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Archive for June, 2012

Biomarkers identified for recurrence in HBV-related HCC patients post surgery

Posted in Biological Networks, Gene Regulation and Evolution, CANCER BIOLOGY & Innovations in Cancer Therapy, Disease Biology, Small Molecules in Development of Therapeutic Drugs, Genome Biology, Liver & Digestive Diseases Research, tagged biomarkers, Birc3, Cancer - General, cell cycle protein, cyclin B1, HBV, HCC, Hepatocellular carcinoma, immunohistochemistry, microarray, PBMC, RT-PCR, Sec62, surgery, tumor on June 25, 2012| 2 Comments »

Author and Reporter: Ritu Saxena, Ph.D.

On June 4, 2012, I authored a post on HBV and HCV-associated Liver Cancer: Important Insights from the Genome http://pharmaceuticalintelligence.com/2012/06/04/hbv-and-hcv-associated-liver-cancer-important-insights-from-the-genome/ reporting about the major role of chromatin remodeling complexes and involvement of both interferon and oxidative stress pathways in hepatocellular malignant proliferation and transformation based on the genes showing recurrent mutations in the observed genes.

In this post, I have discussed the latest research on cyclin B1 and Sec62 expression in PBMCs of HCC patients and how their elevated expression correlates to significantly to negative prognostic value in terms of recurrence-free survival.

Researchers at the Changhai and Gongli Hospital in Shanghai, Military Medical University, People’s Republic of China recently identified the candidate biomarkers for HBV-related HCC recurrence after surgery. The research was published in the June 2012 issue of Molecular Cancer journal. According to the group findings, Cyclin B1 and Sec62 may serve as effective biomarkers and potential therapeutic targets for HBV-related HCC recurrence after surgery.

Research article: Identification of cyclin B1 and Sec62 as biomarkers for recurrence in patients with HBV-related hepatocellular carcinoma after surgical resection. http://www.ncbi.nlm.nih.gov/pubmed/22682366

HCC background and Research Problem: Hepatocellular carcinoma is cancer of the liver. It is different from Metastaticc liver cancer, which starts in another organ (such as the breast or colon) and spreads to the liver. The most frequent factors causing HCC include chronic viral hepatitis (types B and C), alcohol intake and afla- toxin exposure.

In most cases, scarring of the liver referred to as cirrhosis is an important risk factor for HCC. Cirrhosis may be caused by:

Alcohol abuse (the most common cause in the United States)
Autoimmune diseases of the liver
Hepatitis B or C virus infection
Inflammation of the liver that is long-term (chronic)
Iron overload in the body (hemochromatosis)

http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001325/.

However, patients with hepatitis B or C are at risk for liver cancer, even if they have not developed cirrhosis.

According to the data from International Agency for Research on Cancer, hepatocellular carcinoma (HCC) is the third leading cause of cancer-related deaths worldwide, with over a half million deaths per annum. http://www-dep.iarc.fr/

In China, a very high infection rates with HBV have been reported. According to the recent statistics reported by Jemal et al in 2011, HCC cases occurring in China account for 55% of the total cases reported in the world. http://www.ncbi.nlm.nih.gov/pubmed?term=Global%20Cancer%20Statistics%20Jemal

Surgical resection, although provides an opportunity for cure, however, frequent recurrence post surgery has posed a major challenge to longterm survival. Pertinent to their research, authors state “Frequent tumor recurrence after surgery is related to its poor prognosis. Although gene expression signatures have been associated with outcome, the molecular basis of HCC recurrence is not fully understood..”.

Research: To determine the molecular basis of HCC, authors used the Peripheral blood mononuclear cells (PBMCs) to predict the recurrence of HCC after surgery. Use of PBMCs was in contrast to previous studies that used just the liver tissues. PBMCs have the advantage of being easily obtained in the clinical setting. Thus, identification of biomarkers using PBMCs would be a great way to predict the recurrence of HCC post surgery.

A microarray-based gene expression profiling was performed to indentify candidate genes related to HCC recurrence. In all, mRNA derived from 6 HCC cases (3 cases with recurrence and 3 without recurrence) were subjected to genome-wide analysis. Some critical genes were indentified including cyclin B1 (CCNB1), SEC62 homolog (S. cerevisiae) (SEC62), and baculoviral IAP repeat-containing 3 (BIRC3), suggesting that they probably play important roles in the pathogenesis of HCC recurrence. To confirm the results of microarray analysis, the mRNA and protein expressions of these 3 genes were measured in 80 HCC samples from HCC cases and 30 samples from healthy cases. The authors found that the transcriptional and protein expressions of cyclin B1, Sec62, and Birc3 in the PBMCs were significantly higher in HCC samples than those in the non-recurrent and normal samples.

Furthermore, to determine the clinicopathologic significance of cyclin B1, Sec62, and Birc3 in HCC, immunohistochemical analysis from 35 recurrent tissues and 45 nonrecurrent revealed that the protein levels of cyclin B1, Sec62, and Birc3 were substantially higher in the recurrent tissues than those in the non-recurrent samples. Thus, the immunohistochemical results from tissues were consistent with the previous transcriptional and protein results in PBMCs.

Conclusion of study: The authors discussed that “In recent years, studies on malignant tumors has primarily focused on cell proliferation, migration, and apoptosis. Cyclin B1, Sec62, and Birc3, chosen in this study according to our microarray analysis, likely play important roles in cell proliferation and migration. They can exert a tumor-promoting effect on HCC by regulating cell cycle and protein translocation.” As derived from the statistical methods employed in the research, elevated cyclin B1 and Sec62 expression in PBMCs had a significantly negative prognostic value in terms of recurrence-free survival, which hints the potential use of these molecular markers to predict the risk of tumor recurrence after surgery and to act as therapeutic targets to reduce tumor recurrence and improve clinical therapies.

Thus, these results revealed that cyclin B1 and Sec62 may be candidate biomarkers and potential therapeutic targets for HBV-related HCC recurrence after surgery.

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Global Supplier Strategy for Market Penetration & Partnership Options (Niche Suppliers vs. National Leaders) in the Massachusetts Cardiology & Vascular Surgery Tools and Devices Market for Cardiac Operating Rooms and Angioplasty Suites

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Bio Instrumentation in Experimental Life Sciences Research, Cardiac & Vascular Repair Tools Subsegment, Ecosystems & Industrial Concentration in the Medical Device Sector, Exec Compensation in the Cardiac & Vascular Repair Tools Subsegment, Frontiers in Cardiology and Cardiovascular Disorders, Massachusetts Niche Suppliers and National Leaders, Medical Devices R&D and Inventions, Mitral Valve: Repair and Replacement, Stents & Tools, Valves & Tools, tagged Aortic valve, Coronary stent, Edwards Lifesciences, Edwards Lifesciences Corporation, Industry Concentration Ratio in Medical Devices Markets, Market Penetration Cost, Market Penetration in Medical Devices Market, Niche supplier, Peripheral, Stent, Vascular surgery on June 22, 2012| 12 Comments »

Global Supplier Strategy for Market Penetration & Partnership Options (Niche Suppliers vs. National Leaders) in the Massachusetts Cardiology & Vascular Surgery Tools and Devices Market for Cardiac Operating Rooms and Angioplasty Suites

Curator: Aviva Lev-Ari, PhD, RN

The ecosystem of Cardiac and Vascular Surgery for Repair or Replacement by Implantation of a new blood vessel or medical device covers the following procedure-related devices and tools now in use:

Arterial catheterization kit
Embolectomy catheters
Occlusion catheter
Coronary stents
Neurovascular stents
Carotid stents
External and internal carotid shunts
Peripheral stents
Biliary stents
Micro vascular clips
Stainless steel tunneler vascular graft
Cardiopulmonary bypass vascular catheter
Coronary stent graft system
Catheter tip occluder
Synthetic/biological composite vascular graft
Valvulotome tools
Aortic Valve
Mitral Valve
Angioplasty Guided Wires

No Aorta valve suppliers in MA. The National Leader supplier Edwards Lifesciences and its SAPIEN product for Transcatheter Aortic-Valve Implantation (TAVI) and Replacement (TAVR) is covered in Executive Compensation and Comparator Group Definition in the Cardiac and Vascular Medical Devices Sector: A Bright Future for Edwards Lifesciences Corporation in the Transcatheter Heart Valve Replacement Market 6/20/2012

http://pharmaceuticalintelligence.com/2012/06/19/executive-compensation-and-comparator-group-definition-in-the-cardiac-and-vascular-medical-devices-sector-a-bright-future-for-edwards-lifesciences-corporation-in-the-transcatheter-heart-valve-replace/

Medical Devices Market in Massachusetts: Product Concentration Ratios (1 to 10) by Product and Partnership Target Advantage – Niche Suppliers vs. National Leader in the Cardiology & Vascular Surgery Tools and Devices in use in Cardiac Operating Rooms and in Angioplasty Suites

Industry Concentration Ratios per Product Line in the Cardiac and Vascular Medical Devices Segments
A	B	C	D	E	F	G	H	I	J
		US comparison				MA comparison
Cardiology & Vascular Surgery Tools and Devices in use	Global Suppliers	US Suppliers	Market share	Global ratio	Index	MA Suppliers	Market share	Global ratio	Index
Arterial catheterization kit	4	6	0.09	0.40	5.6	2	0.14	0.67	3.6
Embolectomy catheters	11	28	0.03	0.28	1.9	3	0.07	0.79	2.4
Occlusion catheter	1	7	0.11	0.13	2.8	3	0.20	0.25	2.4
Coronary stents	11	34	0.02	0.24	1.7	2	0.07	0.85	2.6
Neurovascular stents	2	6	0.11	0.25	4.5	1	0.25	0.67	5.5
Carotid stents	1	12	0.07	0.08	1.7	1	0.33	0.50	5.5
External and internal carotid shunts	2	5	0.13	0.29	5.5	2	0.20	0.50	3.7
Peripheral stents	0	7	0.13	0.00	1.0	1	0.50	0.00	1.0
Biliary stents	7	13	0.05	0.35	3.1	1	0.11	0.88	3.6
Micro vascular clips	3	6	0.10	0.33	5.2	2	0.17	0.60	3.7
Stainless steel tunneler vascular graft	3	3	0.14	0.50	10.0	1	0.20	0.75	5.1
Cardiopulmonary bypass vascular catheter	14	39	0.02	0.26	1.6	5	0.05	0.74	2.0
Coronary stent graft system	0	6	0.14	0.00	1.0	1	0.50	0.00	1.0
Catheter tip occluder	1	6	0.13	0.14	3.3	2	0.25	0.33	3.3
Synthetic/biological composite vascular graft	3	5	0.11	0.38	6.3	2	0.17	0.60	3.7
Valvulotome tools	3	6	0.10	0.33	5.2	1	0.20	0.75	5.1
Aortic Valve	2	9	0.08	0.18	2.9	0	0.33	1.00	10.0
Mitral Valve	4	7	0.08	0.36	4.8	0	0.20	1.00	6.4
Angioplasty Guided Wires	8	11	0.05	0.42	3.7	2	0.09	0.80	3.0
					126				27
Source for A, B, C, G – http://www.medicregister.com
Source for D,E,F,H,I,J – Computed ratios per formulas below byAviva Lev-Ari, PhD, RN
D = 1/(1+B+C) = projected market share assuming non-differential production capacity

E = B/(B+C) = fraction of global among all suppliers

F = DE$F$24+1 = product of “D” and “E”, scaled to be in the range from 1 to 10

“H” is the same as “D” but with MA suppliers replacing “US suppliers”
“I” is the same as “E” but with MA suppliers replacing “US suppliers”
“J” is the same as “F” but with MA suppliers replacing “US suppliers”

Product Advantage for Partnership with Niche Suppliers in MA

Product Concentration Ratio (PRC) for Tools and Devices in use in Cardiology & Vascular Surgery	Targeting a Niche Supplier based in Massachusetts	Aiming at the Industry Leader
Arterial catheterization kitPRC = 3.6	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Smiths Medical ASD, Inc Weston
External and internal carotid shuntsPRC = 3.7	Bard Electrophysiology www.bardep.comLowell Lemaitre Vascular, Inc. www.lemaitre.com Burlington
Micro vascular clipsPRC = 3.7	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Life Instrument Corporation www.lifeinstruments.com Braintree
Stainless steel tunneler vascular graftPRC = 5.1	Lemaitre Vascular, Inc. www.lemaitre.comBurlington
Cardiopulmonary bypass vascular catheterPRC = 2	Abiomed, Inc. www.abiomed.comDanvers Vortex Medical Inc www.angiovac.com Norwell Lemaitre Vascular, Inc. www.lemaitre.com Burlington Clinical Instruments Intl., Inc. Southbridge Smiths Medical ASD, Inc Weston
Coronary stent graft systemPRC = 2.6	Lemaitre Vascular, Inc. www.lemaitre.comBurlington
Catheter tip occluderPRC = 2.4	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Clinical Instruments Intl., Inc. Southbridge
Valvulotome toolsPRC = 5.1	Lemaitre Vascular, Inc. www.lemaitre.comBurlington

Product Advantage for Partnership with National Leader in MA

Cardiology & Vascular Surgery Tools and Devices in use	Niche Supplier based in Massachusetts	Industry Leader
Neurovascular stentsPRC = 5.5		Boston Scientific Corporation www.bostonscientific.comNatick
Carotid stents PRC = 5.5		Boston Scientific Corporation www.bostonscientific.comNatick
Peripheral stentsPRC = 1		Boston Scientific Corporation www.bostonscientific.comNatick
Biliary stentsPRC = 3.6		Boston Scientific Corporation www.bostonscientific.comNatick

Product Advantage for Partnership with Niche Suppliers and National Leader in MA

Cardiology & Vascular Surgery Tools and Devices in use	Niche Supplier based in Massachusetts	Industry Leader
Embolectomy cathetersPRC = 2.4	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Clinical Instruments Intl., Inc. Southbridge	Boston Scientific Corporation www.bostonscientific.comNatick
Occlusion catheterPRC = 2.4	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Telemed Systems Inc. www.telemedsystems.com Hudson	Boston Scientific Corporation www.bostonscientific.comNatick
Coronary stentsPRC = 2.6	Lemaitre Vascular, Inc. www.lemaitre.comBurlington	Boston Scientific Corporation www.bostonscientific.comNatick
Synthetic/biological composite vascular graftPRC = 3.7	Lemaitre Vascular, Inc. www.lemaitre.comBurlington	Boston Scientific Corporation www.bostonscientific.comNatick
Angioplasty Guided WiresPRC = 3.0	Arrow International, Walrus DivisionWoburn	Boston Scientific Corporation www.bostonscientific.comNatick

Source:

http://www.medicregister.com/Cardiology_Vascular_Surgery/Categories/cid2.htm

Penetration Strategy for a Global Supplier Targeting the US Market in Massachusetts

Customized predictions of penetration cost and estimation of potential revenues based on the industry segment concentration ratios in the Table above per Partnership Option are part of an Actionable Strategic Market Entry Plan in Massachusetts.

Contact Us

Aviva Lev-Ari, PhD, RN

Leaders in Pharmaceutical Business Intelligence

Founder & Director of Pharmaceutical Business Intelligence Services

1-617-244-4024

avivalev-ari@alum.berkeley.edu

Follow me on

http://www.linkedin.com/in/avivalevari

https://twitter.com/#!/pharma_BI

http://www.linkedin.com/groups?gid=4346921&trk=hb_side_g

blog: http://pharmaceuticalintelligence.com

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Competition in the Ecosystem of Medical Devices in Cardiac and Vascular Repair: Heart Valves, Stents, Catheterization Tools and Kits for Open Heart and Minimally Invasive Surgery (MIS)

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Bio Instrumentation in Experimental Life Sciences Research, CABG, Cardiac & Vascular Repair Tools Subsegment, Ecosystems & Industrial Concentration in the Medical Device Sector, Frontiers in Cardiology and Cardiovascular Disorders, Massachusetts Niche Suppliers and National Leaders, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Mitral Valve: Repair and Replacement, Pharmacotherapy of Cardiovascular Disease, Stents & Tools, Valves & Tools, tagged Angioplasty Suite, Cardiac & Vascular Repair, Cardiac Surgery Operating Room, Industry Concentration Ratio in Medical Devices Markets, Market Penetration Cost, Market Penetration in Medical Devices Market, National Leader Supplier, Niche supplier, Potential Revenue by Partnership Options on June 22, 2012| 20 Comments »

Competition in the Ecosystem of Medical Devices in Cardiac and Vascular Repair: Heart Valves, Stents, Catheterization Tools and Kits for Open Heart and Minimally Invasive Surgery (MIS)

Curator: Aviva Lev-Ari, PhD, RN

This report covers the following product categories

Heart Valve Frames:

Transcatheter Aortic-Valve Implantation (TAVI) and Replacement (TAVR)
Aortic-Valve Implantation and Replacement in Open Heart Surgery (AVR)
Mitral Valve

Stents:

Coronary stents
Neurovascular stents
Carotid stents
Peripheral stents
Biliary stents

Surgical tools:

Endoscopic surgical tools
Guide wires for trans-catheter interventions (angioplasty)

The National Leader Supplier Edwards Lifesciences and its SAPIEN product for Transcatheter Aortic-Valve Implantation (TAVI) and Replacement (TAVR) is covered in Executive Compensation and Comparator Group Definition in the Cardiac and Vascular Medical Devices Sector: A Bright Future for Edwards Lifesciences Corporation in the Transcatheter Heart Valve Replacement Market 6/20/2012

The ecosystem of Cardiac and Vascular Surgery for Repair or Replacement by Implantation of a new blood vessel or medical device covers the following procedure-related devices and tools now in use:

Arterial catheterization kit
Embolectomy catheters
Occlusion catheter
Coronary stents
Neurovascular stents
Carotid stents
External and internal carotid shunts
Peripheral stents
Biliary stents
Micro vascular clips
Stainless steel tunneler vascular graft
Cardiopulmonary bypass vascular catheter
Coronary stent graft system
Catheter tip occluder
Synthetic/biological composite vascular graft
Valvulotome tools
Aortic Valve
Mitral Valve
Angioplasty Guided Wires

Product Category Total US and Total Global Suppliers, Suppliers in MA by Product, Segment Industry Concentration in the US and in MA

Cardiology & Vascular Surgery Tools and Devices in use	Total number of Suppliers	GlobalSupplier	US Supplier	Suppliers in Massachusetts	Segment ConcentrationRatio in US Market	Segment Concentration Ratio in the State of MA
Arterial catheterization kit	10[MA=2]	4	6	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Smiths Medical ASD, Inc Weston	5.6	3.6
Embolectomy catheters	39[MA=3]	11	28	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Clinical Instruments Intl., Inc. Southbridge Boston Scientific Corporation www.bostonscientific.com Natick	1.9	2.4
Occlusion catheter	8[MA=3]	1	7	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Boston Scientific Corporation www.bostonscientific.com Natick Telemed Systems Inc. www.telemedsystems.com Hudson	2.8	2.4
Coronary stents	45[MA=2]	11	34	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Boston Scientific Corporation www.bostonscientific.com Natick	1.7	2.6
Neurovascular stents	8[MA=1]	2	6	Boston Scientific Corporation www.bostonscientific.comNatick	4.5	5.5
Carotid stents	13[MA=1]	1	12	Boston Scientific Corporation www.bostonscientific.comNatick	1.7	5.5
External and internal carotid shunts	7[MA=2]	2	5	Bard Electrophysiology www.bardep.comLowell Lemaitre Vascular, Inc. www.lemaitre.com Burlington	5.5	3.7
Peripheral stents	7[MA=1]	0	7	Boston Scientific Corporation www.bostonscientific.comNatick	1.0	1.0
Biliary stents	20[MA=1]	7	13	Boston Scientific Corporation www.bostonscientific.comNatick	3.1	3.6
Micro vascular clips	9[MA=2]	3	6	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Life Instrument Corporation www.lifeinstruments.com Braintree	5.2	3.7
Stainless steel tunneler vascular graft	6[MA=1]	3	3	Lemaitre Vascular, Inc. www.lemaitre.comBurlington	10.0	5.1
Cardiopulmonary bypass vascular catheter	53[MA=5]	14	39	Abiomed, Inc. www.abiomed.comDanvers Vortex Medical Inc www.angiovac.com Norwell Lemaitre Vascular, Inc. www.lemaitre.com Burlington Clinical Instruments Intl., Inc. Southbridge Smiths Medical ASD, Inc Weston	1.6	2.0
Coronary stent graft system	6[MA=1]	0	6	Lemaitre Vascular, Inc. www.lemaitre.comBurlington	1.0	1.0
Catheter tip occluder	7[MA=2]	1	6	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Clinical Instruments Intl., Inc. Southbridge	3.3	3.3
Synthetic/biological composite vascular graft	8[MA=2]	3	5	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Boston Scientific Corporation www.bostonscientific.com Natick	6.3	3.7
Valvulotome tools	9[MA=1]	3	6	Lemaitre Vascular, Inc. www.lemaitre.comBurlington	5.2	5.1
Aortic Valve	11[MA=0]	2	9	none	2.9	10.0
Mitral Valve	11[MA=0]	4	7	none	4.8	6.4
Angioplasty Guided Wires	21[MA=2]	8	11	Arrow International, Walrus DivisionWoburn Boston Scientific Corporation www.bostonscientific.com Natick	3.7	3.0

Source: Name of products and Names of Suppliers were extracted from: http://www.medicregister.com/Cardiology_Vascular_Surgery/Categories/cid2.htm

Industry Segment Concentration Ratio: Impact on Market Penetration Cost and Potential Revenue and Market Share per Product Line

Industry Concentration Ratios per Product Line in the Cardiac and Vascular Medical Devices Segments
A	B	C	D	E	F	G	H	I	J
		US comparison				MA comparison
Cardiology & Vascular Surgery Tools and Devices in use	Global Suppliers	US Suppliers	Market share	Global ratio	Index	MA Suppliers	Market share	Global ratio	Index
Arterial catheterization kit	4	6	0.09	0.40	5.6	2	0.14	0.67	3.6
Embolectomy catheters	11	28	0.03	0.28	1.9	3	0.07	0.79	2.4
Occlusion catheter	1	7	0.11	0.13	2.8	3	0.20	0.25	2.4
Coronary stents	11	34	0.02	0.24	1.7	2	0.07	0.85	2.6
Neurovascular stents	2	6	0.11	0.25	4.5	1	0.25	0.67	5.5
Carotid stents	1	12	0.07	0.08	1.7	1	0.33	0.50	5.5
External and internal carotid shunts	2	5	0.13	0.29	5.5	2	0.20	0.50	3.7
Peripheral stents	0	7	0.13	0.00	1.0	1	0.50	0.00	1.0
Biliary stents	7	13	0.05	0.35	3.1	1	0.11	0.88	3.6
Micro vascular clips	3	6	0.10	0.33	5.2	2	0.17	0.60	3.7
Stainless steel tunneler vascular graft	3	3	0.14	0.50	10.0	1	0.20	0.75	5.1
Cardiopulmonary bypass vascular catheter	14	39	0.02	0.26	1.6	5	0.05	0.74	2.0
Coronary stent graft system	0	6	0.14	0.00	1.0	1	0.50	0.00	1.0
Catheter tip occluder	1	6	0.13	0.14	3.3	2	0.25	0.33	3.3
Synthetic/biological composite vascular graft	3	5	0.11	0.38	6.3	2	0.17	0.60	3.7
Valvulotome tools	3	6	0.10	0.33	5.2	1	0.20	0.75	5.1
Aortic Valve	2	9	0.08	0.18	2.9	0	0.33	1.00	10.0
Mitral Valve	4	7	0.08	0.36	4.8	0	0.20	1.00	6.4
Angioplasty Guided Wires	8	11	0.05	0.42	3.7	2	0.09	0.80	3.0
					126				27
Source for A, B, C, G – http://www.medicregister.com
Source for D,E,F,H,I,J -Computed ratios per formulas below by Aviva Lev-Ari, PhD, RN
D = 1/(1+B+C) = projected market share assuming non-differential production capacity

E = B/(B+C) = fraction of global among all suppliers

F = DE$F$24+1 = product of “D” and “E”, scaled to be in the range from 1 to 10

“H” is the same as “D” but with MA suppliers replacing “US suppliers”
“I” is the same as “E” but with MA suppliers replacing “US suppliers”
“J” is the same as “F” but with MA suppliers replacing “US suppliers”

Penetration Strategy for a Global Supplier Targeting the US Market and the Massachusetts Market

Customized predictions of penetration cost and estimation of potential revenues based on the industry segment concentration ratios in the Table above are part of an Actionable Strategic Market Entry Plan into the US market.

Contact Us

Aviva Lev-Ari, PhD, RN

Leaders in Pharmaceutical Business Intelligence

Founder & Director of Pharmaceutical Business Intelligence Services

1-617-244-4024

avivalev-ari@alum.berkeley.edu

Follow me on

http://www.linkedin.com/in/avivalevari

https://twitter.com/#!/pharma_BI

http://www.linkedin.com/groups?gid=4346921&trk=hb_side_g

blog: http://pharmaceuticalintelligence.com

National Medical Device Suppliers within the Cardiac and Vascular Repair Market by Product Category

Cardiology vascular surgery – The OR equipment

Bard Electrophysiology www.bardep.com

Lowell, Massachusetts Bard Electrophysiology develops & markets products, which aid in the diagnosis and treatment of electrophysiology disorders. Our products include therapeutic, diagnostic & mapping, intracardiac access, temporary pacing electrodes, and EP systems. Our Scorpion®2 Ablation Catheter brings exception more…

Edwards Lifesciences Corporation www.edwards.com

Irvine, California Edwards Lifesciences Corporation delivers acute hemodynamic monitoring & heart valves. Our new perimount magna heart valve (bioprosthesis), with its supra-annular design, offers optimal hemodynamics and flow characteristics for treatment of aortic heart valve diseases. Our embolectomy catheters are more…

Bridgepoint Medical, Inc. www.bridgepointmedical.com

Plymouth, Minnesota Bridgepoint Medical, Inc. deals with the field of interventional cardiology for access to and treatment of chronic total occlusions(CTOs). The Crossboss™ CTO catheter and the Stingray™ CTO re-entry system are used to improve physician access to chronic total occlusions. This occlusion oc more…

Futurematrix Interventional +1-(903)-6779166

Athens, Texas Futurematrix Interventional supplies a range of disposable medical devices. Our products include catheters and stents, angioplasty & angiography catheters, vascular stent delivery systems, hydrophilic urethral stents, and biopsy guns. We provide radiology, cardiology, and urology applications. We al more…

Edwards Lifesciences Technology Sarl +1-(949)-250-2500

Anasco Edwards Lifesciences Technology Sarl offers surgical products. Our products include angiography catheters, arterial blood sampling kit, central venous catheter kit, disposable pressure dome, irrigation catheter, fluid delivery tubing, vascular clamps, physiological patient monitors, intravascular ad more…

Peridot Corporation www.peridotcorp.com

Pleasanton, California Peridot Corporation specializes in the production of medical products. We provide pulmonary drug delivery systems, cardiovascular & gastrointestinal treatments, rf/thermal ablations, laproscopic, endoscopic instruments, & arthroscopic instruments, chemotherapy & stent delivery systems and catheters. more…

Medtronic Ablation Frontiers LLC www.ablationfrontiers.com

Carlsbad, California Medtronic Ablation Frontiers LLC is specialized in the treatment of ablation therapy by developing safety devices & solutions for individuals suffering from atrial fibrillation & other cardiac arrhythmias. Our product, cardiac ablation per-cutaneous catheter provides a minimally invasive treatment f more…

Endophotonix, Inc +1-(651)-452-3000

Eagan, Minnesota Endophotonix Inc. designs and manufactures laser-based surgical ablation systems. The products are indicated for the delivery of laser light for the incision, excision, dissection, vaporization, ablation or coagulation of soft tissue, including cardiac tissue, during surgical procedures. The Atrilaz more…

Csa Medical, Inc. www.csamedical.com

Baltimore, Maryland Csa Medical, Inc. deals with cryospray ablation systems. Our cryospray ablation system removes diseased tissue by rapidly freezing and thus destroying the unwanted tissue. The system transports low-pressure liquid nitrogen through a specially designed catheter that is passed through a standard endos more…

Guidant Corporation www.guidant.com

St. Paul, Minnesota Guidant Corporation is involved in the design and development of cardiovascular medical products. We offer products for the treatment of arrhythmias, heart failure, coronary artery and peripheral vascular diseases. Our implantable cardioverter defibrillators are used to treat heart rhythms that are more…

Biotronik GmbH & Co. www.biotronik.com

Germany Biotronik GmbH & Co. manufactures medical products for the electrotherapy of the heart and vascular intervention. Our astron pulsar self-expanding stent utilises technology in stent conception to create a device that ensures flexibility & improved vessel wall scaffolding. Our Pheron® offers a le more…

Medtronic CryoCath LP www.cryocath.com

Quebec, Canada Medtronic CryoCath LP is a medical technology company that creates catheters & probe-based cryotherapy products to treat cardiovascular diseases. We offer products such as Freezor®, Freezor® Xtra, Freezor® MAX & CryoConsole. Our product medtronic cryocath has developed a minimally invasiv more…

Cardima, Inc. www.cardima.com

Fremont, California Cardima, Inc. designs, manufactures & markets microcatheter systems for the mapping & ablation of cardiac arrhythmias. Arrhythmias are abnormal electrical heart rhythms that adversely affect the mechanical activities of the heart and can significantly affect a person’s quality of life & be potential more…

Alsius Corporation www.alsius.com

Irvine, California Alsius Corporation specializes in intravascular thermal regulation technology. Our Icy™ catheter is inserted into the femoral vein and resides in the inferior vena cava. It delivers target temperature and control rewarm after cooling in neuro surgery & cardiac surgery. All Alsius® heat exc more…

Flowcardia, Inc. www.flowcardia.com

Sunnyvale, California Flowcardia, Inc. deals with the design and development of a portfolio of catheter-based technologies to facilitate guidewire crossing of totally occluded coronary & peripheral arteries. Our Crosser® 14 catheter uses high-frequency vibration to facilitate navigation of guidewires beyond chronic t more…

Venetec International, Inc. venetec.com

San Diego, California Venetec International, Inc. supplies medical products. We specialize in catheter securement technology. Our Statlock® devices protect patients and healthcare workers by reducing potential complications & accidental needlesticks. Our StatLock® stabilization devices replace tape & suture, redu more…

Codman & Shurtleff, Inc. www.codman.com

Raynham, Massachusetts Codman & Shurtleff, Inc. develops and markets a wide range of diagnostic & therapeutic products for the treatment of central nervous system disorders. Our focus is on intractable pain management, pediatric & adult hydrocephalus, and neuro critical care. Our product line includes drug pumps, cerebros more…Geister Medizintechnik GmbH www.geister.com

Tuttlingen, Germany Geister Medizintechnik GmbH is a manufacturer of specialized surgical products carrying a full range of advanced surgical instruments and devices. We work in the three business fields such as cardio, neuro and powered. We develop innovative product and process solutions for coronary artery bypass gr more…

Kaisers Surgical Instruments Pty Ltd www.kaisers.com.au

Western Australia, Australia Kaisers Surgical Instruments Pty Ltd is a supplier of high quality Kaiser branded surgical instruments. Our instrument menu comprises of orthopaedic, ophthalmic, general, ENT and cardio instruments. Our repair service offers a fast and efficient means of restoring damaged surgical instruments regard more…

Arterial catheterization kit suppliers

Arrow International, Inc. www.arrowintl.com

Reading, Pennsylvania Arrow International, Inc. combines technology and product innovation to extend the use of catheterization for the diagnosis & treatment of critically ill patients. Our disposable critical care catheterization products are used principally to access the central vascular system for administration of f more…

Lemaitre Vascular, Inc. www.lemaitre.com

Diablo Sales & Marketing, Inc. www.diablosales.com

Diablo, California Diablo Sales & Marketing, Inc. specializes in OEM components to the medical device and high technology sectors. We provide resources for new product designs incorporating the latest engineered material design technologies. We have access to CAD/CAM, solid works and pro/engineer technology for design more…

Angiodynamics, Inc. www.angiodynamics.com

Queensbury, New York Angiodynamics, Inc. provides medical devices for radiologists, surgeons, and other physicians. We offer medical devices for the minimally invasive diagnosis and treatment of cancer and peripheral vascular disease. Our product line includes market-leading radio frequency ablation systems, vascular ac more…

Smiths Medical ASD, Inc

Weston, Massachusetts Smiths Medical ASD, Inc supplies devices that are used during critical & intensive care, surgery, post-operative care during recovery & in a series of high-end home infusion therapies. We focus on developing technologies that offer both clinical & economic advantages to our healthcare providers and more…

Ayra Medikal Yatirimlar Limited Sirketi

Dikmen, Turkey Ayra Medikal Yatirimlar Limited Sirketi manufactures and distributes range of disposable medical devices for use in cardiology, radiology, critical care unit and operation rooms. more…

Intra Special Catheters GmbH www.intra-online.de

Germany Intra Special Catheters GmbH specilizes in catheters. Our product range comprises of arterial catheters, thoracic drainage catheters, central venous catheters and catheters for vessel surgery. The Microseld PTFE is suited for non-traumatic puncture of peripheral arteries for complication-free positi more…

Marconi Medizintechnik Deutschland GmbH +49-(6122)-9140

Germany Marconi Medizintechnik Deutschland GmbH offers medical products. more…

Biomedical Industry Group Inc. www.biomedgroup.com

Ontario, Canada Biomedical Industry Group Inc. manufactures Rollachair™, Needlegard™, Catheterdriver™ and Arterialpressurestand™. Our Rollachair™ is hygienic and meets infection control standards. Our pressure stand is used with a sterile pad during arterial catheterization process. more…

Embolectomy catheters suppliers

Arrow Internacional De Mexico, S.A. De C.V. +52-(610)-378-0131

Mexico Arrow Internacional De Mexico, S.A. De C.V. offers multiple sterile needleless injection hub, wire guides and various intravascular catheters. more…

Atrium Medical Corporation www.atriummed.com

Hudson, New Hampshire Atrium Medical Corporation manufactures breakthrough medical device technologies used in open heart surgery, emergency chest trauma, thoracic drainage and surgical repair of diseased blood vessels. We are an ISO 9000, ISO 9001, ISO 9002 & CE MARK certified company. We offer products like cardiology, more…

Ev3, Inc. www.ev3.net

Plymouth, Minnesota Ev3, Inc. is a medical device company that focuses on catheter based or endovascular, technologies for the minimally invasive treatment of vascular diseases and disorders. We offer neuro products such as embolic coils, liquid embolics, micro catheters, Guidewires, balloons, carotoid stents & embolic more…

Alsius Corporation www.alsius.com

Cook Vascular IncorporatedSEND INQUIRY

Vandergrift, Pennsylvania Cook Vascular Incorporated provides interventional, therapeutic and diagnostic vascular products. We also manufacture a complete line of Vital-port® vascular access ports and a wide variety of catheters, introducers & specialty components. Our lead extraction system is a collection of specialize more…

Vascular Solutions Inc. www.vascularsolutions.com

Minneapolis, Minnesota Vascular Solutions Inc. develops products for the interventional cardiologist and interventional radiologist. Our D-Stat products are based on the scientifically proven hemostatic power of thrombin. Our Vari-Lase endovenous laser system is designed to help physicians provide advanced treatment for v more…

Cook Group Incorporated www.cookgroup.com

Bloomington, Indiana Cook Group Incorporated focuses on the research and product development in minimally invasive medical device technology for diagnostic & therapeutic procedures. Our wire-guided arndt endobronchial blocker set allows one-lung ventilation using a conventional endotrachael tube and a pediatric fiberopt more…

Cordis Corp. +1-(786)-313-2000

Miami Lakes, Florida Cordis Corp., a Johnson & Johnson company develops products to treat circulatory system diseases including congestive heart failure and cerebral aneurysms. Its product lines include the balloons, catheters, forceps, guidewires, and plain and drug-coated stents used in cardiology, endovascular, and n more…

Edwards Lifesciences Corporation www.edwards.com

Medtronic Xomed Surgical Products, Inc www.xomed.com

Jacksonville, Florida Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, Integrated Power Console System, Pillar® System, Big Easy® Piston, and ENT-5000 Video Endosco more…

Merit Medical Systems, Inc. www.merit.com

South Jordan, Utah Merit Medical Systems, Inc. manufactures medical devices used in diagnostic and interventional cardiology & radiology procedures. Our primary products are inflation devices, diagnostic and therapeutic catheters, guide wires, pressure monitoring disposables, fluid delivery systems, medication syringe more…

Medtronic, Inc. www.medtronic.com

Minneapolis, Minnesota Medtronic, Inc. specializes in medical technology, thus providing lifelong solutions for people with chronic pain. We focus on cardiac rhythm disease management (CRDM), spinal & biologics, cardiovascular, neuromodulation, diabetes, and surgical technologies. Our cardiac resynchronization therapy (CR more…

Hotspur Technologies, Inc. www.hotspur-inc.com

Mountain View, California Hotspur Technologies, Inc. develops catheter-based technologies aimed at restoring blood flow for patients with obstructed vessels. The IQCath™ balloon dilatation catheter is a specialty three-in-one device that allows the physician to perform angioplasty, deliver targeted contrast, and perfor more…

Nexgen Medical Systems, Inc.SEND INQUIRY

Reno, Nevada Nexgen Medical Systems, Inc. specializes in developing medical devices. Our medical devices improve safety & efficacy of interventional procedures in patients with neurological and cardiovascular diseases. Our products include embolic protection device, and mechanical clot retrieval device. We provi more…

Pfm Medical, Inc www.pfmmedical.com

Oceanside, California Pfm Medical, Inc specializes in products such as EZ Huber®, pfm PICC Catheters, and interventional cardiology. The EZ huber isolates the caregiver from harmful patient fluids and oncology drug splatter. PICC catheters & trays provides increased flexibility to both administer and medications & pe more…

Lemaitre Vascular, Inc. www.lemaitre.com

Micrus Endovascular Corporation www.micrusendovascular.com

San Jose, California Micrus Endovascular manufactures & markets both implantable and disposable medical devices used in the treatment of cerebral vascular diseases. Our products are used by interventional neuroradiologists and neurosurgeons primarily, to treat cerebral aneurysms in the brain which are responsible for he more…

Spectranetics Corporation, The www.spectranetics.com

Colorado Springs, Colorado The Spectranetics Corporation manufactures and markets the excimer laser system for use in minimally invasive interventional procedures within the cardiovascular system. The spectranetics laser system utilizes a wavelength of 308 nanometers in the ultraviolet region of the light spectrum. The laser more…

Artegraft, Inc. www.artegraft.com

North Brunswick, New Jersey Artegraft, Inc. specializes in offering Collagen Vascular Graft™. Artegraft is a natural collagen vascular graft. Its biological fibrous matrix is processed to enhance long term patency and provide a tightly woven, cross-linked conduit that is flexible & compliant. It is used for segmental byp more…

Arrow International, Inc www.neocare.com

San Antonio, Texas Arrow International, Inc. develops, manufactures and markets a broad range of catheter based therapeutic products. Our Arrow SmartSeal™ hemostatic peelable dialysis sheath is designed to minimize risk of air embolism, minimize blood loss, and reduce clinician’s exposure to blood-borne pathogen more…

Lumen Biomedical, Inc. www.lumenbio.com

Plymouth, Minnesota Lumen Biomedical, Inc. offers interventional devices for embolic protection and thrombus removal throughout the body. Our FiberNet® embolic protection system features a low crossing profile for optimal device deliverability. Its proprietary filter design promotes conformability to asymmetrical v more…

Lucas Medical, Inc. www.lucasmedicalinc.com

Anaheim, California Lucas Medical, Inc. specializes in silicone medical products. Our product portfolio comprises of embolectomy catheters, occlusion catheters, biliary catheters, carotid shunts, thrombectomy catheters, straight irrigation catheters and bi-lumen irrigation catheters. Our arterial embolectomy catheters more…

Clinical Instruments Intl., Inc. +1-(508)-764-2200

Southbridge, Massachusetts Clinical Instruments Intl., Inc. provides carotid bypass shunt, introducers and detergent reagent. more…

Biosensors International USA www.biosensors.com/usa

Newport Beach, California Biosensors International USA develops, manufactures and markets medical devices for interventional cardiology & critical care procedures. Acutrans™ is our fully disposable blood pressure transducer system that is used in invasive blood pressure measurement with lowest possibility of zero drift more…

Applied Medical www.appliedmedical.com

Rancho Santa Margarita, California Applied Medical is associated with clinical areas such as general surgery, urology, vascular, cardiac, colorectal and Ob/Gyn surgery. We have introduced GelPort® laparoscopic system, Kii® abdominal access system, Acucise® endopyelotomy/endoureterotomy system, Direct Drive® graspers a more…

Sorin Group USA, Inc. www.soringroup-usa.com

Arvada, Colorado Sorin Group USA, Inc. designs and manufactures cardiac perfusion & blood management systems. Our D100 oxygenator is designed for neonatal procedures. It is designed to reduce allogenic blood product usage and can have a positive effect on patient outcomes. The flow rates are under 700 cc/minute. Our more…

Edwards Lifesciences Technology Sarl +1-(949)-250-2500

Medrad, Inc. www.medrad.com

Warrendale, Pennsylvania Medrad, Inc. deals in medical devices and services that enable & enhance imaging procedures of the human body. We are engaged in the production of vascular injection systems for diagnostic or interventional procedures. We manufacture and market a complete line of CT injection systems. We also offer more…

Boston Scientific Corporation www.bostonscientific.com

Natick, Massachusetts Boston Scientific Corporation specializes in the development, manufacturing and marketing of medical devices. We also design and produce cardiovascular medical products. Our cardiovascular division concentrates on providing medical treatment to cardiovascular, peripheral vascular & neurovascular dis more…

Venetec International, Inc. venetec.com

Biosensors Intl. Pte. Ltd. www.biosensors.com

Singapore Biosensors Intl. Pte. Ltd. serves as the manufacturing centre for critical care products such as embolectomy catheters, thermodilution catheters,and central venous catheters. more…

Senko Medical Trading Co. www.senko-trd.co.jp

Japan Senko Medical Trading Co. distributes medical products. We focus on cardiothoracic, surgical products, anesthesia, and otolaryngologic products. more…

Invatec Innovative Technologies, S.R.L. www.invatec.com

Italy Invatec Innovative Technologies, S.R.L. is a producer of catheters. Our coronary products include Falcon CTO, Piccolo, Bravo, Grande & Forte, Avion plus, Skylor and Skipper. Our peripheral products are Hippocampus, Scuba, Admiral xtreme, Maris plus & deep. Our Falcon CTO balloon catheter provides so more…

3by Ltd. www.3by.com

Israel 3by Ltd. specializes in turn-key projects of medical components, devices and systems. We provide clean room production, sophisticated plastic injection molding services, technical design assistance, assembly and product testing. Our solutions include injection, automatic assembly, product testing an more…

Pfm Produkte für die Medizin AG www.pfm-ag.de

Germany Pfm Produkte für die Medizin AG is a marketing and sales specialist for medical technology products in the fields of pathology/histology, OP/anesthesia, infusion therapy & interventional technologies. We offer various products including anterior chamber cannulas, anti roll device sets, aprons, arter more…

Intra Special Catheters GmbH www.intra-online.de

Dispomedica GmbH www.dispomedica.de

Germany Dispomedica GmbH deals with healthcare products under categories such as anesthesia, neuro surgery, cardio surgery and sterilization. The ventricular catheters are designed for temporary drainage of cerebrospinal fluid (CSF), in order to reduce and control intracranial pressure. The temporary myocar more…

Vascutech, Inc. +33-(800)-628-9470

France Vascutech, Inc. provides vascular balloon catheter and biliary catheter. more…

Occlusion catheter suppliers

Lemaitre Vascular, Inc. www.lemaitre.com

Catheter Research, Inc. (CRI) www.catheterresearch.com

Indianapolis, Indiana Catheter Research, Inc. (CRI) is a manufacturer and developer of medical devices. We specialize in catheters, tubing and OEM medical device manufacturing. We have numerous patents describing various catheters and similar medical devices with single and multiple elements of shape memory nitinol. The more…

Telemed Systems Inc. www.telemedsystems.com

Hudson, Massachusetts Telemed Systems Inc. is manufacturer of medical accessory devices which are utilized with the flexible endoscope in the field of gastroenterology. Our product line includes polypectomy snares, gastrointestinal cytology brushes, bronchial cytology brushes, balloon catheters, disposable sclerotherapy more…

Boston Scientific Corporation www.bostonscientific.com

Dispomedica GmbH www.dispomedica.de

Billary stents

Vitae Core www.vitaecore.com

Cypress, California Vitae Core is a specialized medical device company involved in the marketing and distribution of OEM/branded products. We offer urology, radiology, gastroenterology, braces/back supports, scissors and dental instruments. Our urology products include urethral balloon catheter, slings, nephrostomy bal more…

Cordis Corp. +1-(786)-313-2000

Polymerex Medical Corp. www.polymerex.com

San Diego, California Polymerex Medical Corp. specializes in providing PTCA, PTA balloon catheters, stents and accessories. We also offer variety of components including tubing, medical balloon, luer and hub. We provide plastics, lubricious & heat shrink tubing, biliary, esophageal & tracheal stent, torque device and ins more…

Flexible Stenting Solutions, Inc. www.flexiblestent.com

Eatontown, New Jersey Flexible Stenting Solutions, Inc. is engaged in the business of stents. Our stenting solutions technology is designed for the harsh loading conditions in the superficial femoral and popliteal arteries, which are in the dominant sites and peripheral vascular diseases. Our fully connected stent has co more…

Allwin Medical Devices, Inc. www.allwinmedical.com

Anaheim, California Allwin Medical Devices, Inc. manufactures urology products. Our urology products include biopsy needles, dilators, guidewires, stone buster pneumatic lithotripters, meatal dilators and urinary diversion stents. We offer needles, catheters, drainage sets, speciality stents, stent removers, stone bask more…

Cordis Corporation, A Johnson & Johnson Co. www.cordis.com

Warren, New Jersey Cordis Corporation, A Johnson & Johnson Co. is a developer and manufacturer of breakthrough stents, catheters and guidewires for interventional medicine, minimally invasive computer-based imaging, and electrophysiology. We offer products for cardiology, endovascular, and biliary. Our brands include more…

Idev Technologies, Inc. www.idevtechnologies.com

Houston, Texas Idev Technologies, Inc. supplies medical device products designed for endovascular interventional use. Our Supera® transhepatic biliary stent uses the novel wire interwoven nitinol (WIN) design which offers great conformity to the natural biliary duct and 1:1 nominal sizing. Above or below the k more…

Medi-Globe Corporation www.mediglobe.com

Tempe, Arizona Medi-Globe Corporation is a developer, manufacturer and distributor of instruments, catheters, devices, implants & equipment for flexible endoscopy, urology, cardiology and wound care. We also distribute a wide range of hospital supplies. We focus on the minimally invasive surgical market with speci more…

Hobbs Medical Inc. www.hobbsmedical.com

Stafford Springs, Connecticut Hobbs Medical Inc. specializes in the design and development of diagnostic & therapeutic accessories for the gastrointestinal & pulmonary market. Our achalasia balloon dilator is manufactured from specially treated polyurethane. It has standard luer-lock fittings for compatibility with inflation/def more…

Bard Peripheral Vascular, Inc. www.bardpv.com

Tempe, Arizona Bard Peripheral Vascular, Inc. deals with vascular products. Our product list comprises of abdominal/thoracic grafts, hemodialysis access grafts, peripheral bypass grafts, stents, stent grafts, and venacava filters. The LifeStent® vascular stent has a combination of helical structures, encompass more…

Boston Scientific Corporation www.bostonscientific.com

Abbott Laboratories www.abbott.com

Abbott Park, Illinois Abbott Laboratories is a diversified health care company which discovers, develops, manufactures and markets innovative products & services that span the continuum of care from prevention, diagnosis to treatment & cure. We focus on advancing medical science & the practice of health care with experti more…

Guidant Corporation www.guidant.com

Olympus KeyMed Ltd. www.keymed.co.uk

Essex, United Kingdom Olympus KeyMed Ltd. manufactures and supplies specialized medical & industrial equipments. We manufacture high-quality electro-optical products, such as cameras & microscopes and endoscopic instrumentation for both medical & industrial applications. Our product categories are laparo-endoscopic singl more…

ACE Medical Devices Pvt. Ltd.SEND INQUIRY

Maharashtra, India Ace Medical Devices Pvt. Ltd. manufactures and distributes medical devices. We are an ISO 9001:2001 and ISO 13485 certified company. Our products are CE-certified in accordance with MDD 93/42/EEC. We offer urology & gastro disposables, and disposable laparoscopic scissors. Our products include ureth more…

Manish Medi-Innovation saimanish.com

Karnataka, India Medi-Innovation produces super specialty surgical disposables in the field of urology, gynaecology and gastroenterology. We deal in stents, catheters, dilators, guide wire, graspers, IP needles, penile clamps, stone baskets and rigid graspers. Endoscopic biliary stents, endoscopic biliary drainage c more…

Aster Medispro Pvt Ltd www.astermedispro.net

Karnataka, India Aster Medispro produces medical devices in the specialities of urology, radiology, gastroenterology and gynaecology. Our products include PCN catheter, malecot catheter, suprapublic catheter, prostatic stent, ureteral dilator, stone basket, stone grasper, loop stent, and tieman. Our urethral indwell more…

Medi-Globe GmbH www.medi-globe.de

Germany Medi-Globe GmbH produces and distributes minimal-invasive instruments & accessories used in the fields of gastroenterology & flexible endoscopy. We also deal with wound care systems. We have DIN EN ISO 13485: 2003 certification to our credit. Some of our products are biopsy forceps, foreign body ret more…

Taewoong Medical Co., Ltd www.stent.net

Korea, Republic Of Taewoong Medical Co., Ltd develops stents. Our GI stents are used to maintain or restore the lumen of hollow organs, vessels, and ducts. Non-vascular stents are devices to create an artificial pathway, open for hollow lumen organs that are closed or obstructed due to cancerous lesions or benign dise more…

Medinol Ltd. www.medinol.com

Israel Medinol Ltd. specializes in the manufacture of cardiology products with the invention of the flexible closed cell stent design. We focus on the stent technology to combine thicker and thinner strut to optimize the balance between flexibility and scaffolding. Our product line comprises of Nirflex® more…

Carotid shunts suppliers

C. r. Bard, Inc. www.crbard.com

Murray Hill, New Jersey C. r. Bard, Inc. manufactures and markets life-enhancing medical technologies in the fields of vascular, urology, oncology & surgical specialty products. We are an ISO 9000 certified company. We offer products by business unit, disease state, process listing, idea generation process, OEM & E commerc more…

Bard Electrophysiology www.bardep.com

Lemaitre Vascular, Inc. www.lemaitre.com

Perouse Medical www.perouse.com

France Perouse Medical specializes in cardiovascular surgery, oncology and interventional imaging fields. Our products for cardiovascular surgery include knitted and woven polyester vascular prostheses, balloon catheters, carotid shunts and vein strippers. Our implantable catheter port is flexible and with more…

External and internal carotid shunts suppliers

Sophysa USA, Inc. www.sophysa.com

Crown Point, Indiana Sophysa USA, Inc. specializes in adjustable valves. Our lumbo-peritoneal catheter kit is a complete set that ensures drainage of cerebrospinal fluid (CSF) from the subarachnoid space of the spine to a sophy valve & from the valve to the peritoneal cavity. Our Pulsar® valve is endowed with a one way device & allows patency checking & CSF access & is available in 2 sizes and 3 pressure ranges. Our infusion sets to be used with Soph-A-Port implantable access port are available, simple or with l more…

Lemaitre Vascular, Inc. www.lemaitre.com

Burlington, Massachusetts LeMaitre Vascular, Inc. is a global provider of devices for the treatment of peripheral vascular disease. We develop, manufacture, and market disposable & implantable vascular devices to address the needs of vascular surgeons & interventionalists. Our product portfolio consists of brand name products used in arteries and veins outside of the heart. We offer stent grafts, biologic vascular patch, carotid shunts, covered stents, contrast injector, and implantable ports. The UniFit aorto-uni-iliac more…

Micro vascular clips suppliers

Roboz Surgical Instrument Co., Inc. www.roboz.com

Gaithersburg, Maryland Roboz Surgical Instrument Co., Inc. specializes in providing hand-crafted surgical instruments. Our surgical instruments include tweezers & forceps, bone instruments, surgical & vascular clips & clamps, scalpels, retractors, wound closure & vascular access instruments, instrument care & handling pro more…

Stoelting Co. www.stoeltingco.com

Wood Dale, Illinois Stoelting Co. produces and distributes instruments for basic biomedical research in neuroscience & physiology. Our ANY-maze™ is a flexible video tracking system designed to automate testing in behavioural experiments more…

Aesculap Inc. www.aesculapusa.com

Center Valley, Pennsylvania Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Our cardiovascular instruments includes peripheral vascular, aorta, anastomosis clamps, vascular clips more…

Lemaitre Vascular, Inc. www.lemaitre.com

RZ-Medizintechnik Gmbh www.rz-medizintechnik.com

Germany RZ-Medizintechnik GmbH offers standard and speciality instruments & accessories for various surgical fields such as arthroscopy, ENT, urology, ophthalmology, & plastic surgery. We offer a complete set of laryngoscopes for adults and children. These laryngoscopes permit a good view of the laryngeal a more…

Stainless steel tunneler vascular graft suppliers

Teleflex Medical www.teleflexmedical.com

Research Triangle Park, North Carolina Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical devices and orthopedic surgical instruments. Our OEM brands include Beere Medical, KMedic, Deknatel more…

Lemaitre Vascular, Inc. www.lemaitre.com

C. R. Bard, Inc., Bard Medical Div. www.bardmedical.com

Covington, Georgia C. R. Bard, Inc., Bard Medical Div. provides products and services that meet the needs of healthcare providers & patients. We specialize in disease state management offering the industry’s comprehensive product inventory for patient care. We offer a full line of Foley catheters including infection c more…

Zeppelin Medical Instruments Ltd. www.zeppelin.md

Germany Zeppelin Medical Instruments Ltd. produces and distributes medical products. Our haematoscope is designed for neuro endoscopic surgery where a large working channel and best image information is needed. Our trepanmotor is designed in particular for the cranial burr hole trepanation at low speed. Our more…

General Surgical Co., (india) Pvt. Ltd. www.gescoindia.com

Tamil Nadu, India General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic, cardio thoracic, urology, oncology, vascular, ophthalmic, dental, oral & maxillofacial surgery ins more…

Baur Und Haselbarth-Chirurg Gmbh www.bh-chirurg.de

Germany Baur Und Haselbarth-Chirurg GmbH is a manufacturer of surgical instruments. We manufacture a broad variety of surgical instruments including aspiration & suction instruments, atomizers, ear specula, gynecological instruments, retractors, trachea tubes and rectal instruments. Our aspiration & suction more…

Vascular stent suppliers

DRG International, Inc. www.drg-international.com

Mountainside, New Jersey DRG International, Inc. is a multinational specialty medical equipment and diagnostics manufacturer & distributor. We offer products for enzyme immunoassays, rapid saliva & tumor tests, radio immunoassays & lab equipments. Our enzyme immunoassays include adrenocorticotropic hormone, alpha fetoprotei more…

Atrium Medical Corporation www.atriummed.com

Cordis Corp. +1-(786)-313-2000

Vascular Architects, Inc.SEND INQUIRY

San Jose, California Vascular Architects, Inc. designs, manufactures and markets instrumentation used in the treatment of vascular stenoses, occlusions and non-vascular obstructions. A key area of emphasis is the treatment of peripheral vascular disease, which manifests itself as a reduction or loss of blood flow due to more…

Lemaitre Vascular, Inc. www.lemaitre.com

Fort Wayne Metals www.fwmetals.com

Fort Wayne, Indiana Fort Wayne Metals specializes in the research, development and production of fine grade medical wire. We work with stainless steel, titanium and titanium alloys and specialty alloys such as nitinol. Our products include flat and shaped wires, center less and precision ground bar, drawn filled tubing more…

Bard Peripheral Vascular, Inc. www.bardpv.com

Micro-tech (Nanjing) Co., Ltd. www.micro-tech.cn/indexen.htm

Jiangsu, China Micro-tech (Nanjing) Co., Ltd develops, manufactures & distributes stents series products, biopsy forceps and other medical devices for minimal invasive operation. We perform sterilization inspection for our single use medical devices. Our product line includes biliary duct, colonic, duodenal, esoph more…

Tayside Flow Technologies Limited www.tayflow.com

United Kingdom Tayside Flow Technologies Limited focuses on the development of vascular devices. We offer vascular devices that are based on blood flow dynamics spiral laminar flow technology. Our SLF™ spiral grafts are monitored by conventional techniques to determine the effects on the pressure and flow ch more…

Cardio-Nef, S.A. De C.V. www.cardionef.com

N.L., Mexico Cardio-Nef, S.A. De C.V. provides coronary stent, guide wire catheter and catheter introducer. more…

Taewoong Medical Co., Ltd www.stent.net

Contech Medical International, Ltd. www.contechireland.com

Ireland Contech Medical International, Ltd. is an OEM sub-contract manufacturer servicing the medical device industry. We offer OEM medical device assembly & packaging, winged infusion and straight needle sets, both uncoated & coated balloon, stent protectors, catheter & guide wire dispensers. Our technical more…

Micro-Tech (Nan Jing) Co., Ltd. www.stent.cc

China Micro-Tech (Nan Jing) Co., Ltd. manufactures & distributes stent series products, biopsy forceps and medical devices for minimally invasive operations. We perform sterilization inspection for single use medical devices. Our product line comprises of biliary duct, colonic, duodenal, esophageal, prost more…

Cardiopulmonary bypass vascular catheter suppliers

Autosuture www.autosuture.com

Norwalk, Connecticut Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO 9001, ISO 9002, CE MARK certified company. We offer products like endo catch™ 10mm specimen bag, end more…

Chase Medical www.chasemedical.com

Richardson, Texas Chase Medical designs & manufactures products for the comprehensive surgical treatment of congestive heart failure, including products for surgical ventricular restoration procedures and for both beating heart & traditional CABG procedures. We offer products such as catalyst, Marisa™, Mannequin & PT more…

Abiomed, Inc. www.abiomed.com

Danvers, Massachusetts Abiomed, Inc. develops & distributes heart assist and replacement systems. We offer healthcare professionals an array of choices across a broad clinical spectrum from the catheterization lab to the surgical suite, together with interventional cardiologists and surgeons. Our AbioCor is a completely s more…

Cook Group Incorporated www.cookgroup.com

Viasys Healthcare Inc www.viasyshealthcare.com

San Diego, California Viasys Healthcare Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-level nasal CPAP for the spontaneously breathing neonate through delivery of sighs above a baseline more…

Edwards Lifesciences Corporation www.edwards.com

Medtronic Xomed Surgical Products, Inc www.xomed.com

Integra LifeSciences Corporation www.integra-ls.com

Plainsboro, New Jersey Integra LifeSciences Corporation develops & markets surgical instruments, as well as devices and products for use in neurosurgery, reconstructive surgery, general surgery and soft tissue repair. Our Samy™ vascular retractors enable the neurosurgeon to elevate, retract and depress the vessel, t more…

Luxtec www.luxtec.com

West Boylston, Maryland Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monitors, printers, and light sources. Our ultralite consists of ergonomic designs that use the head’s nat more…

Medtronic, Inc. www.medtronic.com

Vortex Medical Inc www.angiovac.com

Norwell, Massachusetts Vortex Medical Inc specializes in novel endomechanical devices for the endovascular market. We provide AngioVac® cannula and circuit. It is a novel catheter-based device that facilitates the suction, filtering, and simultaneous reinfusion of blood. The AngioVac® cannula, a unique balloon-act more…

Endoscopic Technologies, Inc. www.estech.com

San Ramon, California Endoscopic Technologies, Inc. develops medical devices and disposables that enable cardiac surgeons to perform a variety of traditional and minimally invasive surgical procedures. Our Cobra Adhere XL™ surgical system is a minimally invasive epicardial probe that utilizes ten electrodes to crea more…

Global Blood Resources, Llc +1-(800)-9429243

Windsor, Connecticut Global Blood Resources, Llc offers cardiopulmonary bypass blood reservoir and cardiopulmonary bypass vascular catheters. more…

Pemco, Inc. www.pemcomed.com

Cleveland, Ohio Pemco, Inc. is a manufacturer of precision surgical instruments that include custom perfusion systems. Our products include anesthesia shield, suction handles, suction sets, suction tips, cannula connectors, heart pumps and retractors. Our anesthesia shield provides a protective area around the pati more…

Cardeon Corp. +1-(408)-253-3319

Cupertino, California Cardeon Corp. specializes in providing various catheters, cannula & tubing, vascular and cardiopulmonary bypass products. more…

Cardiac Assist, Inc. www.cardiacassist.com

Pittsburgh, Pennsylvania CardiacAssist, Inc. develops, manufactures and markets medical device products to provide cardiologists and cardiac surgeons. Our product range includes tandemheart cannula set, tandemheart controller and tandemheart system pump. Our tandemheart transseptal cannula set-enhanced flow 72 provides exte more…

Circulatory Technology, Inc. www.cirtec.com

Oyster Bay, New York Circulatory Technology, Inc. develops medical devices to improve the safety and efficacy of cardiopulmonary bypass. Our products include The Better-Bladder™ (BB), The V-Bag™, The Better-Header™ and The Better-Venter™. The Better-Bladder™ (BB) is an inline reservoir that more…

Lemaitre Vascular, Inc. www.lemaitre.com

Cascade Life Solutions, LLC +1-(616)-977-2505

Grand Rapids, Michigan Cascade Life Solutions, LLC are providers of tourniquet kit with snares, cardioplegia cannulae, sucker and cardiovascular accessories. more…

Avalon Laboratories, Inc. www.avalonlabs.com

Rancho Dominguez, California Avalon Laboratories, Inc. is a supplier of wire-reinforced catheters and cannulae. Our products include vascular access kits, bi-caval dual lumen and multi-port venous femoral catheters. The bi-caval dual lumen catheter is a single site, kink resistant, veno-venous device designed to enable optimal more…

Voss Medical Products vossmedicalproducts.com

San Antonio, Texas Voss Medical Products is a medical device developer/specifier specializing in surgical products. Our product categories are positioning, cardiovascular and specialty. We offer positioning devices, and graft markers, cannulas, and clamps used in coronary bypass procedures. Our single use disposable P more…

Alliant Healthcare Products www.allianthealthcare.com

Richland, Michigan Alliant Healthcare Products designs, develops, manufactures and markets products for the healthcare market. We also provide custom assembly, packaging and manufacturing for acute care hospitals, government & original equipment (OEM) for private label customers. We focus on cardiovascular, general su more…

Vitalcor, Inc. www.vitalcor.com

Westmont, Illinois Vitalcor, Inc. manufactures and distributes medical devices used primarily in cardio-thoracic surgery. We specialize in coronary artery perfusion cannulae with balloon. The balloon is made of self-inflating PVC with no latex. more…

Atek Medical www.atekmedical.com

Grand Rapids, Michigan Atek Medical is a producer of medical products. We manufacture class II and III disposable, implantable and electro-mechanical devices. We have extensive assembly capabilities that include UV bonding, ultrasonic welding, pad printing, laser marking, FFS packaging, tray sealing, bar sealing, catheter more…

Shelhigh, Inc. www.shelhigh.com

Union, New Jersey Shelhigh, Inc. offers SemiStented™ aortic tricuspid valves, stentless aortic valves, stentless valve conduit, and tricuspid valves. The NR2000 stentless aortic valves offers supravalvular implantation using single layer continuous suture line. It requires no rinsing and is available in a wide more…

California Medical Laboratories www.calmedlab.com

Costa Mesa, California California Medical Laboratories develops, distributes and manufactures cardiovascular cannulation products. Our product line includes cardiovascular cannulation products, cardioplegia products, vent catheters, suction wands, beating heart products, custom cannulation kits & accessories. Our custom c more…

Surge Medical Solutions, LLC. www.surgemedical.com

Grand Rapids, Michigan Surge Medical Solutions, LLC. provides solution for cardiovascular surgery, emergency services and emergency preparedness as well as a variety of other healthcare markets. Our retrograde provides the means for delivering cardioplegia solution to the patient’s heart. The cannulae permit delivery of c more…

Bard Shannon Limited +1-(908)-277-8000

Humacao Bard Shannon Limited supplies medical devices and diagnostic equipments. Our product line includes biopsy systems, mesh bags and precision pass. more…

Churchill Medical Systems, Inc. www.churchillmedicalsystems.com

Montgomeryville, Pennsylvania Churchill Medical Systems, Inc. is a manufacturer of procedure kits, IV sets and accessories, TPN bags & pharmacy admixture products. We offer a complete custom product program. Our extension sets include standard bore extension sets, micro bore extension sets, minibore & ultra-microbore extension s more…

C. R. Bard, Inc., Bard Medical Div. www.bardmedical.com

Jostra Bentley, Inc. +1-(302)-454-9959

Anasco Jostra Bentley, Inc. offers various surgical and disposable medical products. We provide arterial filters, blood infusion line, cardioplegia cooling/administration set, cardiotomy venous reservoirs, custom cardiovascular perfusion kits, disposable sucker, oxygen saturation meter, pleural drainage/au more…

Vygon Corp. www.vygonusa.com

Norristown, Pennsylvania Vygon Corp. deals with single-use medical and surgical products. Our neonatal & pediatric special care products are categorized as vascular access, digestive tract and respiratory tract. The PremiCath is a 27G (1.1 Fr) Flexane® catheter for mid-long term I.V.therapy. Its 24G splitting introducer more…

Clinical Instruments Intl., Inc. +1-(508)-764-2200

Southbridge, Massachusetts Clinical Instruments Intl., Inc. provides carotid bypass shunt, introducers and detergent reagent. more…

Terumo Medical Corporation +1-(410)-392-7243, 800-283-7866

Elkton, Maryland Terumo Medical Corporation deals with blood specimen collection devices, coaxial introducers, entry needles, guide wires, phlebotomy needle cap holders, and piston syringes. more…

Sorin Group USA, Inc. www.soringroup-usa.com

Terumo Cardiovascular Systems www.terumo-cvs.com

Ann Arbor, Massachusetts Terumo Cardiovascular Systems (TCVS) develops, manufactures and distributes medical devices for cardiac & vascular surgery with an emphasis on cardiopulmonary bypass, intra–operative monitoring & vascular grafting. The Fresenius continuous autotransfusion system (C.A.T.S) salvages red blood cells fo more…

Atrion Medical Products, Inc. www.atrionmedical.com

Arab, Alabama Atrion Medical Products, Inc., a division of Atrion Corporation specializes in medical devices. Our product lines provide solutions for a variety of medical markets such as cardiovascular, orthopedic, ophthalmic, urological and anesthesia. Our QL® inflation device is perfect for a wide array of more…

Smiths Medical ASD, IncSEND INQUIRY

Smiths Medical Deutschland GmbH www.smiths-medical.com/de

Germany Smiths Medical Deutschland GmbH provides medical devices for the hospital, emergency, home and specialist environments. Our Point-Lok® device is a needle safety solution for needles found in epidural, spinal and other procedural trays. Our BCI® 3301 pulse oximeter and Digit™ finger pul more…

Erika De Reynosa, S.A. De C.V. +52-(899)-921-3500

Mexico Erika De Reynosa, S.A. De C.V. specializes in offering orthopedic, prosthetic and surgical appliances & supplies. Our products include tubing clamps, catheter connectors, I.V. administration sets, single needle blood sets & accessories, and various types of blood tubing sets, transducer protectors f more…

Kelsar, S.A. +52-(0)-89-41-86

Mexico Kelsar, S.A. specializes in offering catheter bags, intraventricular probes and oxygen & bag feeder. Our Argyle DeLee suction catheter with mucous trap is intended to aspirate liquids or semisolids from a patient’s upper airway. more…

Terumo Corporation www.terumo.co.jp

Tokyo, Japan Terumo Corporation manufactures & distributes medical products & equipment that include pharmaceuticals, nutritional food supplement, blood bags, disposable medical devices, cardiovascular systems, peritoneal dialysis, blood glucose monitoring system, medical electronic and digital thermometers. Our more…

Dideco S.P.A. www.sorin-cp.com

MO, Italy Dideco S.P.A. focuses on perfusion and blood management systems. Our products include endoscopic vessel harvesting, cardiopulmonary equipment, oxygenators, optimized bypass systems, venous and cardiotomy reservoirs, arterial filters, cardioplegia, hemoconcentration, monitoring, centrifugal blood pum more…

Sorin S.p.A.SEND INQUIRY

Italy Sorin S.p.A. focuses on the development of products used to treat cardiovascular and renal diseases. Our product categories are endoscopic vessel harvesting, cardiopulmonary equipments, oxygenators, arterial filters and cannulae & suckers. Our ClearGlide® ERA for endoscopic radial harvesting ena more…

DMC Medical Ltd. www.dmcmedical.net

Ireland DMC Medical Ltd. offers manufacturing, consultancy and distribution service to the medical device sector. Our product list comprises of saphenous vein distention systems, cardiac insulation pads, vein irrigation cannulas, and polycarbonate connectors. The saphenous vein distention system (SVDS) prev more…

Admedes Schuessler Gmbh www.admedes.com

Germany Admedes Schuessler Gmbh provides nitinol self expandable components to medical industries. Our product line comprises of nitinol stents, percutaneous heart valve frames, filters, occlusion devices and distal protection devices. We also specialize in laser cuttings, shape settings, surface finishes, more…

Maquet Cardiopulmonary Ag www.maquet-cp.com

Germany Maquet Cardiopulmonary Ag is a provider of medical technology for emergency rooms, operating rooms and intensive care units. We offer complete solutions for operating theatres and intensive care units. We supply OR tables, lights and complete OR solutions. Endoscopic vessel harvesting or EVH is a pr more…

Bionic Medizintechnik GmbH www.bionic-jms.com

Taunus, Germany Bionic Medizintechnik GmbH specializes in the distribution of dialysis and transfusion products. We also manufacture catheters and therapy chairs & beds. We offer a wide range of medical single-use products. We supply blood bags and equipments needed for blood transfusion. Demers-Katheter® is a more…

Vygon S A www.vygon.com

France Vygon S A offers single use medical and surgical products. We focus on urinary tract surgery, wound drainage, digestive tract, respiratory tract, neonatology, and operation theater products. Our urinary tract products include pediatric vesical catheters, rectal catheters, hourly diuresis and urine d more…

Allegiance Healthcare Corp. 847-473-1500

Dominican Republic Allegiance Healthcare Corp are providers of introducer needle reusables, disposable bome marrow biopsy needles and trays. more…

Davis And Geck Caribe, Ltd. 203-845-1000

Dominican Republic Davis And Geck Caribe, Ltd. specializes in the production of polytetrafluorethylene pledget, disposable endoscopic specimen pouch, steel sutures and umbilical tape-sterile round cotton tape. more…

Cardiomed Supplies Inc. www.cardiomed.com

Ontario, Canada Cardiomed Supplies Inc. is a manufacturer and distributor of disposable surgical products. We supply disposable products for open heart surgery, critical care, dialysis, and oncology. Our comprehensive product line includes renal and peritoneal dialysis catheters, catheters for intensive and critica more…

Coronary stent graft system suppliers

TriReme Medical, Inc. www.trirememedical.com

Pleasanton, California TriReme Medical, Inc. specializes in providing products for physicians to use in the treatment of coronary artery disease. We offer Antares™ coronary stent system and Glider™ PTCA balloon catheter. Our Glider™ PTCA balloon catheter can be used to dilate highly-stenosed lesions. more…

Elixir Medical Corporation www.elixirmedical.com

Sunnyvale, California Elixir Medical Corporation develops products that combine medical devices with pharmaceuticals to provide treatment solutions. Drug-eluting stent systems are designed to optimize localized drug delivery to provide a safe treatment for cardiovascular patients. Our coronary stent is manufactured from more…

Lemaitre Vascular, Inc. www.lemaitre.com

Abbott Hematology www.abbott.us

Santa Clara, California Abbott Hematology offers pharmaceutical, medical, and nutritional products. Our product range comprises of medicines, medical diagnostic instruments & tests, minimally invasive surgical devices, and a spectrum of nutritional supplements for infants, children & adults. Our perclose A-T suture medicat more…

Medtronic Neurosurgery +1-(901)-344-0645 , 800-468-9710

Goleta, California Medtronic Neurosurgery deals with cranial neurosurgery market. Our products include a wide variety of PS Medical® silicone elastomer valves, catheters, & shunts for hydrocephalus management, neuroendoscopes for improved surgical access and cranial closure products for quick & secure reattachment more…

Catheter tip occluder suppliers

Teleflex Medical www.teleflexmedical.com

Cook Group Incorporated www.cookgroup.com

Medtronic Xomed Surgical Products, Inc www.xomed.com

Lemaitre Vascular, Inc. www.lemaitre.com

Clinical Instruments Intl., Inc. +1-(508)-764-2200

Southbridge, Massachusetts Clinical Instruments Intl., Inc. provides carotid bypass shunt, introducers and detergent reagent. more…

Applied Medical www.appliedmedical.com

Codan Medical Aps www.codan.de

Denmark Codan Medical Aps is a manufacturer of disposable medical transfer systems. Our products include infusion sets, transfusion sets, I.V. accessories, pediatric products, syringes, I.V. pumps and continence care products. more…

Synthetic/biological composite vascular graft suppliers

Datascope Corp. www.datascope.com

Fairfield, New Jersey Datascope Corp. offers intervascular and cardiac assist products. We offer balloon pumps, balloon catheters, sutureless securement devices, vascular grafts and peripheral stents. Our CS300 balloon pump with IntelliSense™ combines fiber-optic speed with automatic in vivo calibration. The result more…

Atrium Medical Corporation www.atriummed.com

Lemaitre Vascular, Inc. www.lemaitre.com

Maquet Inc. www.maquet.com

Wayne, New Jersey Maquet Inc. designs equipment and disposables for cardiac surgery. We provide products for ventilation, perfusion systems, cardiac surgery and cardiopulmonary products. We also produce different types of operating tables and lights. more…

Boston Scientific Corporation www.bostonscientific.com

Terumo Corporation www.terumo.co.jp

Perouse Medical www.perouse.com

Bionova International Pty. Ltd. www.bionova.com.au

VIC, Australia Bionova International Pty. Ltd. manufactures vascular prostheses. Our Omniflow II is a biosynthetic vascular prosthesis fpr peripheral revascularization and arteriovenous access. Our research and testing laboratories are equipped to conduct many specialized evaluations on the physico-chemical charac more…

Valvulotome suppliers

Koven Technology, Inc. www.koven.com

St. Louis, Missouri Koven Technology, Inc offers healthcare products. We are an ISO certified company. Our HD-307 is a versatile bi-directional surgical doppler & has a special single frequency unit created for optimal sound quality in low flow states. Our echosounder ES-102EX is a heavy-duty desktop fetal doppler that more…

Edwards Lifesciences Corporation www.edwards.com

Scanlan International www.scanlaninternational.com

St. Paul, Minnesota Scanlan International designs and manufactures surgical instrumentation. Our product categories are cardiac/vascular, neurosurgical, single-use products, instrument care and custom design. Our Scanlan® single-use aorta/vein punches have large finger rings for greater control & accuracy and taper more…

Instrumed International, Inc. www.instrumedinc.biz

Schaumburg, Illinois Instrumed International, Inc. specializes in providing reusable surgical instruments. We offer surgical products for bipolar, CV/thoracic, ENT, general, hand & micro surgery, laparoscopic, laryngeal, maxillo-facial, neuro/spine, OB/GYN, ophthalmic, orthopedic, plastics and urology. We also carry a b more…

Lemaitre Vascular, Inc. www.lemaitre.com

Uresil, LLC www.uresil.com

Skokie, Illinois Uresil, LLC is a medical device development, manufacturing and distribution company that serves the needs of physicians who perform minimally invasive procedures. Our products are categorized into interventional radiology and surgical products. Some of our products are catheter with locking pigtail, more…

Geister Medizintechnik GmbH www.geister.com

Olympus Imaging Corporation www.olympus.co.jp

Japan Olympus Imaging Corporation specializes in medical endoscopes and surgical products,artificial bone replacement material and dental products. We also deal with microscopes and the medical information systems program. The Evis Lucera upper alimentary canal general-purpose video scope corresponds to n more…

Dimeda Instrumente Gmbh www.dimeda.de

Germany Dimeda Instrumente Gmbh specializes in surgical instruments. We offer products for endoscopy, neurosurgery, cardiovascular surgery, gynecology, orthopedics and plastic surgery. Our product list comprises of laryngoscopes, aneurysm vessel clips, saw & power tools, and nasopharyngolaryngoscopes. Our e more…

Guided wires

http://www.neometricsinc.com/technologies.html

Medical Guidewire Expertise from Design Through ManufacturingNeoMetrics Minneapolis, MNare the experts in manufacturing OEM mandrel guide wires and wire-based OEM medical devices. NeoMetrics offers medical guide wires for OEM medical procedures. We specialize in FDA cleared steerable guide wires and nitinol guide wires for OEM medical devices.

Guided Wires MA based

Techdevice Corporation www.techdevice.com

Watertown, Massachusetts Techdevice Corporation manufactures balloons, catheters, coils, ground cores and finished guidewires. We specialize in the development of custom medical balloons. Our balloons are ideal for PTCA and PTA catheters, stent delivery systems, esophageal & endotrachial applications and spine therapies. We more…

Biosphere Medical, Inc. www.biospheremed.com

Rockland, Massachusetts Biosphere Medical, Inc. focuses on applying proprietary microsphere technology to medical applications using embolotherapy techniques. Our core technologies, consisting of patented bio-engineered polymers and manufacturing methods, are used to produce miniature spherical beads with beneficial proper more…

Navilyst Medical, Inc. www.navilystmedical.com

Marlborough, Massachusetts Navilyst Medical, Inc. offers medical devices for vascular access, and for the diagnosis & treatment of vascular disease. Our products are used by various healthcare providers including interventional radiologists, interventional cardiologists, oncologists, surgeons, IV nurses & oncology nurses. We more…

Guidewire Technologies, Inc. guidewiretech.com

Salem, New Hampshire Guidewire Technologies, Inc. offers medical guidewires. Our guidewires come in standard, fixed core, and custom designs. Our capabilities include spring winding, grinding, welding, marking, j-tip forming, and PTFE coating. more…

Angiotech Pharmaceuticals, Inc. www.angiotech.com

Vancouver Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company that discovers, develops, & markets innovative technologies & medical products primarily for local diseases or for complications associated with medical device implants, surgical interventions & acute inj more…

Pace Medical, Inc. www.pacemedicalinc.com

Waltham, Massachusetts Pace Medical, Inc. is involved in designing and marketing a complete line of high-quality temporary cardiac pacing products. Our products include both single and dual-chamber temporary cardiac pacemakers, a dual-chamber pacing analyzer, autoclavable temporary pacemaker extension and surgical cables, more…

Concert Medical www.concertmedical.com

Norwell, Massachusetts Concert Medical provides interventional cardiology products. We offer conductor guidewire family and regional anesthesia products. We provide BSmart™, injection monitor for use in regional anesthesia. It has been designed to provide significant clinical information at a fantastic value. more…

Advanced Biomedical Devices, Inc. (ABD, Inc.) www.abd-inc.com

Andover, Massachusetts Advanced Biomedical Devices, Inc. (ABD, Inc.) provides contract engineering and design. We offer medical grade gas dispenser for balloon inflation with CO2 and CO2 powered injector for thermal dilution. This is useful for filling balloons especially for pediatric and adult procedures, whenever there more…

Radius Medical Technologies, Inc. www.radiusmed.com

Acton, Massachusetts Radius Medical Technologies, Inc. specializes in design, development and marketing of minimally invasive medical devices for treating cardiovascular diseases. Our Expro™ elite snare has a 0.035″ profile that permits delivery through conventional diagnostic or therapeutic catheters elimina more…

Rocket Medical www.rocketmedical.com

Hingham, Massachusetts Rocket Medical deals with products for cardiac and thoracic drainage, ascites drainage, infertility, labor ward, colposcopy, and sterile supplies. Our Rocket® Genesis™ embryo transfer catheter set has a new inner catheter design combined with an ultra smooth tip profile that reduces the ri more…

Boston Scientific Corporation www.bostonscientific.com

Ovalum Ltd. www.ovalum.net

Israel Ovalum Ltd. develops and implements effective and safe solutions for chronic and acute total occlusions in the coronary and peripheral arteries. Based on proprietary shape memory alloy techniques and laser processes we offer systems for minimally-invasive cardiology and interventional radiology fiel more… Ovalum Ltd. develops and implements effective and safe solutions for chronic and acute total occlusions in the coronary and peripheral arteries. Based on proprietary shape memory alloy techniques and laser processes we offer systems for minimally-invasive cardiology and interventional radiology fields. The minimally-invasive solution, the citop™ guidewire system, was created for the treatment of arterial conditions that today require bypass surgery or amputation of the lower limb. Our products citop™ 10 CTO Crossing System is a complete platform for CTO cross-over, traverse™ micro-catheter is a 1.9F (0.025”) micro-catheter for easy penetration & octobooster™ is an extension wire.

Aortic Valve

Cryolife Inc. www.cryolife.com

Kennesaw, Georgia CryoLife® Inc. is a biomedical company that produces low temperature preservation of human tissues for implant. Our CryoLife-O’Brien® stentless aortic porcine valve is made of three non-coronary leaflets & is implanted with a single suture line technique. Our BioGlue® surgical adhesive i more…

Carbomedics Inc. www.carbomedics.com

Austin, Texas Carbomedics Inc. specializes in the development of products for treatment of valvular heart disease. We focus on products used to treat cardiovascular & renal diseases. Our OrbisTM universal aortic and mitral valve have a multipurpose cuff design, which allows for a variety of implantation technique more…

St. Jude Medical, Inc. www.sjm.com

St. Paul, Minnesota St.Jude Medical, Inc. delivers implantable bradycardia, cardiac surgical, electrophysiology, implant cardiac monitors, repair, tachycardia, tissue valves, spinal cord stimulation, patient care network, mechanical valves, cardioverter defibrillators, pacemakers, electrophysiology catheters, vascular more…

Edwards Lifesciences Corporation www.edwards.com

Nucleus Medical Art Inc. www.nucleusinc.com

Kennesaw, Georgia Nucleus Medical Art Inc. creates and/or licenses medical illustrations, medical animations, medical images, anatomical charts, anatomical models and interactive multimedia for educational and commercial use. We maintain a proprietary database of more than 15,000 highly detailed, expert reviewed medi more…

Direct Flow Medical, Inc. www.directflowmedical.com

Santa Rosa, California Direct Flow Medical, Inc. deals with aortic tissue valve prosthesis. Our aortic tissue valve prosthesis provides treatment for cardiac valve insufficiency with a safe and effective percutaneous option. more…

On-X Life Technologies, Inc www.onxlti.com

Austin, Texas On-X Life Technologies, Inc manufactures the On-X® Prosthetic Heart Valve. Our heart valve is a pure carbon bileaflet heart valve prosthesis. The smooth surfaces of pure carbon, a transitional flare at the inlet and sleek interior contours of the valve diminish the principal causes of turbulence more…

ATS Medical, Inc. www.atsmedical.com

Minneapolis, Minnesota ATS Medical, Inc. caters to the requirements of the cardiovascular surgery market, providing life-sustaining solutions for cardiac surgeons and their patients. Our products include ATS Open Pivot® heart valves, ATS 3f® aortic bioprosthesis, ATS simulus® annuloplasty valve repair rings/bands and ATS more…

Shelhigh, Inc. www.shelhigh.com

Sorin Biomedica Cardio S.p.A. www.sorin-cid.com

Via Crescentino, Italy Sorin Biomedica Cardio S.p.A. specializes in the field of high-technology bioengineering. We manufacture heart valves. Our bicarbon slimline valve is designed for supra-annular placement of the whole sewing cuff. Our soprano aortic bioprosthesis is created for a totally supra-annular seating, which more…

Minogue Medical, Inc. www.minogue-med.com

Quebec, Canada Minogue Medical, Inc. is engaged in the production of surgical robot. We offer da Vinci ® surgical robot that enables surgeons to control every aspect of surgery. Our da Vinci ® prostatectomy offers robotic surgery for prostate cancer or robotic prostatectomy. It is a minimally invasive surg more…

Mitral Valve

Carbomedics Inc. www.carbomedics.com

St. Jude Medical, Inc. www.sjm.com

Edwards Lifesciences Corporation www.edwards.com

Nucleus Medical Art Inc. www.nucleusinc.com

On-X Life Technologies, Inc www.onxlti.com

Shelhigh, Inc. www.shelhigh.com

Thomas Medical Products, Inc. www.thomas-medical.com

Malvern, Pennsylvania Thomas Medical Products, Inc. is a medical device manufacturer. We design and develop Class II and Class III single-use devices for OEM customers. We focus on catheter based vascular access and vascular device delivery medical devices for diagnostic and therapeutic procedures in the cardiology, elec more…

Landmark Surgical Ltd www.landmark-surgical.co.uk

Merseyside, United Kingdom Landmark Surgical Ltd supplies a wide range of surgical instruments. We offer a wide range of quality instruments for minimally invasive surgery. Our cardio thoracic instruments include forceps, artery forceps, coronary artery bypass retractors, hand held retractors, bulldog clamps, dilators, corona more…

Sorin Biomedica Cardio S.p.A. www.sorin-cid.com

Kaisers Surgical Instruments Pty Ltd www.kaisers.com.au

Minogue Medical, Inc. www.minogue-med.com

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Bone remodelling in a nutshell

Posted in Bone Disease and Musculoskeletal Disease, Cell Biology, Signaling & Cell Circuits, Nitric Oxide in Health and Disease, tagged adaptation, bone architecture, bone mass, bone physiology, bone remodelling, haemostasis, mechanical loading, mechanosensation, mechanosensitive, osteoblasts, osteoclasts, osteocytes on June 22, 2012| 11 Comments »

Author: Aviral Vatsa, Ph.D., MBBS

Bone is a highly dynamic tissue that responds to changes in its external environment. Our bones adapt their mass and architecture according to the external mechanical loading conditions. Any long term alterations in loading conditions result in alteration of bone mass and architecture. This is highlighted in the following examples:

Astronauts tend to lose their bone when they are in space. This is because the bones are not mechanically loaded externally due to absence of or reduction in gravitational force.
Tennis players gain more mass in their playing forearm as compared to the non-playing forearm.

In both these examples bones tend to readjust their internal structural mass and alignment as per the external loads or their absence. How bones can achieve this? How bone forming and bone resorbing cells can be orchestrated to bring about this adaptation?

Bone cells

The questions mentioned above can be answered by knowing more about the cellular components of bone and their functions. Our bones primarily have four cell types: osteocytes, osteoblasts, osteoclasts and bone lining cells. Osteocytes are believed to be the ‘professional’ mechanosensors of bone i.e. they sense the external loads put on bone. Osteoblasts are the bone forming cells. Osteoclasts are the bone resorbing cells and as the name suggests, bone lining cells line the bone surfaces and play a role in regeneration of osteogenic cells. Osteocytes, following mechanical loading, secrete signalling molecules such as nitric oxide (besides others). These signalling molecules then modulate the activity of bone forming osteoblasts and/or bone resorbing osteoclasts. Thus osteocytes orchestrate this process wherein adequate bone mass and architecture is achieved in accordance with the external loading conditions.

Anatomically, the osteocytes reside with in the hard bony matrix. They are the majority cell types in bone and are ideally placed to sense the mechanical loads. Osteocytes have a cell body and from the cell body arise nearly fifty cell processes. Through these cell processes each osteocyte forms a network with the surrounding osteocytes. Through this network, following mechanical loading, osteocytes can stimulate the activity of osteoblasts and inhibit the activity of osteoclasts. This process of maintenance of bone mass and architecture is called bone remodelling. Bone remodelling occurs through out our life. It occurs in response to microfractures, which can appear in our bone without being noticed clinically. As long as our bone metabolism is physiologically normal these stimuli, such as microfractures, result in bone remodelling.

In diseases such as osteoporosis, the mechanism of bone remodelling is disrupted and there is more bone resorbtion than new bone formation thus leading to reduction in bone mass and alteration of bone architecture. Drug therapies for osteoporosis such as bisphosphonates, act by inhibiting the activity of osteoclasts thereby resulting in reduction in bone resorbtion and hence helping in maintenance of adequate bone mass and architecture. Newer therapies that target to modulate a part of bone remodelling are being investigated.

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Cancer and Bone: low magnitude vibrations help mitigate bone loss

Posted in Bone Disease and Musculoskeletal Disease, CANCER BIOLOGY & Innovations in Cancer Therapy, Disease Biology, Small Molecules in Development of Therapeutic Drugs, tagged anabolic agents, bone loss, bone mineral density, Cancer - General, fracture, LIV, low intensity vibtration, mechanosensitive, osteoblastogenesis, osteoblasts, osteopenia, osteoporosis, ovarian cancer, stem cells on June 19, 2012| Leave a Comment »

Cancer and Bone: low magnitude vibrations help mitigate bone loss

Curator and Reporter: Ritu Saxena, Ph.D.

Recently, an article published in the journal Bone described that the low magnitude vibrations might be helpful in mitigating osteopenia in spontaneous granulosa cell ovarian cancer.

Osteopenia is defined as the bone mineral density (BMD) that is lower than normal peak BMD but not low enough to be classified as the diseased condition called osteoporosis. Bone mineral density is a measurement of the level of minerals in the bones, that shows how dense and strong they are. Having osteopenia means there is a greater risk that, as time passes, you may develop BMD that is very low compared to normal, known as osteoporosis

Cancer progression is often paralleled by a decline in bone mass, raising risk of fracture. Loss in bone mass can be therapeutically treated by using bone anabolic agents that increase the process of bone formation compared to bone resorption thus leading to an overall increase in bone mass. However, use of anabolic agents for preventing cancer associated bone loss presents a lot of concern as they may exacerbate cancer tissue expansion.

Bone is a mechanosensitive organ. Osteoblastogenesis, or the process of differentiation of precursor cells to bone forming cells (osteoblasts) is encouraged by low intensity vibration (LIV) via a mechanical signal. Rubin et al explored the possibility of slow cancer-associated bone loss, but this goal must be achieved without fostering disease progression. The hypothesis was tested in the murine model.

Seventy female F1-SWRxSWXJ-9 mice, a strain prone to developing granulosa cell tumors, were divided into three groups – baseline control (BC: n=10), age-matched control (AC: n=30), and LIV (n=30), which received mechanical signals (90Hz @ 0.3g) for 15m/day, 5day/w over the course of 1year. Survival curves observed in the three groups indicated that longevity was unperturbed by LIV. Rubin et al stated that “1year, bone volume of proximal tibiae in LIV mice was 25% greater than AC while bone volume of L5 vertebrae was 16% higher in LIV over AC (p<0.02). Primary lesions and peripheral metastases were apparent in both LIV and AC; however, overall tumor incidence was approximately 30% less in LIV (p=0.27) and, when disease was evident, involved fewer organ systems (p=0.09).”

These experiments indicate that LIV helps protect bone mass in mice inherently susceptible to cancer without compromising life expectancy, perhaps through mechanical control of stem cell fate. Further, these data reflect the numerous system-level benefits of exercise in general, and mechanical signals in particular, in the preservation of bone density and the suppression of cancer progression.

Source: Journal article- http://www.thebonejournal.com/article/S8756-3282(12)00867-8/abstract, http://www.webmd.com/osteoporosis/tc/osteopenia-overview

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The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED)

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cardiac & Vascular Repair Tools Subsegment, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Valves & Tools, tagged Centers for Medicare & Medicaid Services (CMS), Coverage with Evidence Development (CED), FDA, Transcatheter Aortic Valve Replacement on June 19, 2012| 9 Comments »

The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED)

Reporter: Aviva Lev-Ari, PhD, RN

Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N)

The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED) with the following conditions:

TAVR is covered for the treatment of symptomatic aortic valve stenosis when furnished according to an FDA approved indication and when all of the following conditions are met.

The procedure is furnished with a complete aortic valve and implantation system that has received FDA premarket approval (PMA) for that system’s FDA approved indication.

Two cardiac surgeons have independently examined the patient face-to-face and evaluated the patient’s suitability for open aortic valve replacement (AVR) surgery; and both surgeons have documented the rationale for their clinical judgment and the rationale is available to the heart team.

The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care.  TAVR must be furnished in a hospital with the appropriate infrastructure that includes but is not limited to: On-site heart valve surgery program,
Cardiac catheterization lab or hybrid operating room/catheterization lab equipped with a fixed radiographic imaging system with flat-panel fluoroscopy, offering quality imaging,
Non-invasive imaging such as echocardiography, vascular ultrasound, computed tomography (CT) and magnetic resonance (MR),
Sufficient space, in a sterile environment, to accommodate necessary equipment for cases with and without complications,
Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures,
Appropriate volume requirements per the applicable qualifications below.

There are two sets of qualifications; the first set outlined below is for hospital programs and heart teams without previous TAVR experience and the second set is for those with TAVR experience.  Qualifications to begin a TAVR program for hospitals without TAVR experience:

The hospital program must have the following:

≥ 50 total AVRs in the previous year prior to TAVR, including ≥ 10 high-risk patients, and;

≥ 2 physicians with cardiac surgery privileges, and;

≥ 1000 catheterizations per year, including ≥ 400 percutaneous coronary interventions (PCIs) per year.

Qualifications to begin a TAVR program for heart teams without TAVR experience:

The heart team must include:

Cardiovascular surgeon with:

≥ 100 career AVRs including 10 high-risk patients; or

≥ 25 AVRs in one year; or

≥ 50 AVRs in 2 years; and which include at least 20 AVRs in the last year prior to TAVR initiation; and

Interventional cardiologist with:

Professional experience with 100 structural heart disease procedures lifetime; or;

30 left-sided structural procedures per year of which 60% should be balloon aortic valvuloplasty (BAV). Atrial septal defect and patent foramen ovale closure are not considered left-sided procedures; and

Additional members of the heart team such as echocardiographers, imaging specialists, heart failure specialists, cardiac anesthesiologists, intensivists, nurses, and social workers; and

Device-specific training as required by the manufacturer.

Qualifications for hospital programs with TAVR experience:

The hospital program must maintain the following:

≥ 20 AVRs per year or ≥ 40 AVRs every 2 years; and

≥ 2 physicians with cardiac surgery privileges; and

≥ 1000 catheterizations per year, including ≥ 400 percutaneous coronary interventions (PCIs) per year.

Qualifications for heart teams with TAVR experience:

The heart team must include:

A cardiovascular surgeon and an interventional cardiologist whose combined experience maintains the following:

≥ 20 TAVR procedures in the prior year, or;

≥ 40 TAVR procedures in the prior 2 years; and

Additional members of the heart team such as echocardiographers, imaging specialists, heart failure specialists, cardiac anesthesiologists, intensivists, nurses, and social workers.

The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.

The heart team and hospital are participating in a prospective, national, audited registry that: 1) consecutively enrolls TAVR patients; 2) accepts all manufactured devices; 3) follows the patient for at least one year; and 4) complies with relevant regulations relating to protecting human research subjects, including 45 CFR Part 46 and 21 CFR Parts 50 & 56. The following outcomes must be tracked by the registry; and the registry must be designed to permit identification and analysis of patient, practitioner and facility level variables that predict each of these outcomes:

Stroke;

All cause mortality;

Transient Ischemic Attacks (TIAs);

Major vascular events;

Acute kidney injury;

Repeat aortic valve procedures;

Quality of Life (QoL).

The registry should collect all data necessary and have a written executable analysis plan in place to address the following questions (to appropriately address some questions, Medicare claims or other outside data may be necessary):

When performed outside a controlled clinical study, how do outcomes and adverse events compare to the pivotal clinical studies?

How do outcomes and adverse events in subpopulations compare to patients in the pivotal clinical studies?

What is the long term ( ≥ 5 year) durability of the device?

What are the long term ( ≥ 5 year) outcomes and adverse events?

How do the demographics of registry patients compare to the pivotal studies?

Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above-listed standards and address the above-listed research questions.

TAVR is covered for uses that are not expressly listed as an FDA approved indication when performed within a clinical study that fulfills all of the following. The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.

As a fully-described, written part of its protocol, the clinical research study must critically evaluate not only each patient’s quality of life pre- and post-TAVR (minimum of 1 year), but must also address at least one of the following questions:

What is the incidence of stroke?

What is the rate of all cause mortality?

What is the incidence of transient ischemic attacks (TIAs)?

What is the incidence of major vascular events?

What is the incidence of acute kidney injury?

What is the incidence of repeat aortic valve procedures?

The clinical study must adhere to the following standards of scientific integrity and relevance to the Medicare population:

The principal purpose of the research study is to test whether a particular intervention potentially improves the participants’ health outcomes.

The research study is well supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.

The research study does not unjustifiably duplicate existing studies.

The research study design is appropriate to answer the research question being asked in the study.

The research study is sponsored by an organization or individual capable of executing the proposed study successfully.

The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found in the Code of Federal Regulations (CFR) at 45 CFR Part 46. If a study is regulated by the Food and Drug Administration (FDA), it also must be in compliance with 21 CFR Parts 50 and 56. In particular, the informed consent includes a straightforward explanation of the reported increased risks of stroke and vascular complications that have been published for TAVR.

All aspects of the research study are conducted according to appropriate standards of scientific integrity (see http://www.icmje.org).

The research study has a written protocol that clearly addresses, or incorporates by reference, the standards listed as Medicare coverage requirements.

The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard only if the disease or condition being studied is life threatening as defined in 21 CFR §312.81(a) and the patient has no other viable treatment options.

The clinical research study is registered on the http://www.ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollment of the first study subject.

The research study protocol specifies the method and timing of public release of all prespecified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. The results must be made public within 24 months of the end of data collection. If a report is planned to be published in a peer reviewed journal, then that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Editors (http://www.icmje.org). However a full report of the outcomes must be made public no later than three (3) years after the end of data collection.

The research study protocol must explicitly discuss subpopulations affected by the treatment under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria affect enrollment of these populations, and a plan for the retention and reporting of said populations on the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary.

The research study protocol explicitly discusses how the results are or are not expected to be generalizable to the Medicare population to infer whether Medicare patients may benefit from the intervention. Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or Medicaid eligibility.

The principal investigator must submit the complete study protocol, identify the relevant CMS research question(s) that will be addressed and cite the location of the detailed analysis plan for those questions in the protocol, plus provide a statement addressing how the study satisfies each of the standards of scientific integrity (a. through m. listed above), as well as the investigator’s contact information, to the address below. The information will be reviewed, and approved studies will be identified on the CMS website.

Director, Coverage and Analysis Group

Re: TAVR CED

Centers for Medicare & Medicaid Services (CMS)

7500 Security Blvd., Mail Stop S3-02-01

Baltimore, MD 21244-1850

TAVR is not covered for patients in whom existing co-morbidities would preclude the expected benefit from correction of the aortic stenosis.

http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=257&ver=4&NcaName=Transcatheter+Aortic+Valve+Replacement+(TAVR)&bc=ACAAAAAAIAAA&

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Executive Compensation and Comparator Group Definition in the Cardiac and Vascular Medical Devices Sector: A Bright Future for Edwards Lifesciences Corporation in the Transcatheter Heart Valve Replacement Market

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cardiac & Vascular Repair Tools Subsegment, Ecosystems & Industrial Concentration in the Medical Device Sector, Exec Compensation in the Cardiac & Vascular Repair Tools Subsegment, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Uncategorized, Valves & Tools, tagged Aortic valve, Aortic valve stenosis, Cardiac surgery, Edwards Lifesciences Corporation, Edwards SAPIEN, Food and Drug Administration, Heart valve, PARTNER II Clinical Trial, Total stockholder return (TSR), Transcatheter Aortic Valve Replacement (TAVR) on June 19, 2012| 16 Comments »

Curator: Aviva Lev-Ari, PhD, RN

Edwards Lifesciences Corporation, Irvine, California delivers acute hemodynamic monitoring & heart valves. Their new perimount magna heart valve (bioprosthesis), with its supra-annular design, offers optimal hemodynamics and flow characteristics for treatment of aortic heart valve diseases. Their embolectomy catheters are indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

Edwards Lifesciences Reports Strong 2012 Fourth Quarter Results

February 5, 2013

IRVINE, CA, February 04, 2013 — Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today reported net income for the quarter ended December 31, 2012, of $91.1 million, or $0.77 per diluted share, compared to net income of $63.1 million, or $0.53 per diluted share, for the same period in 2011.

During the quarter, the company recorded a global realignment pretax charge of $9.0 million, primarily related to severance costs. Additionally, in its non-GAAP results for the quarter, the company included an $8.4 million tax benefit, which represents the portion of the recently renewed Federal research and development (R&D) tax credit that is retroactive to the beginning of 2012. In the quarter ending March 31, 2013, the company will record the 2012 tax credit as required, but will exclude it from non-GAAP results. The impact of these special items was $0.13 per diluted share.

Adjusting for special items from both periods detailed in the reconciliation table below, fourth quarter diluted earnings per share were $0.90, compared to $0.62 in the prior year quarter, an increase of 45.2 percent.

Fourth quarter net sales increased 18.7 percent to $510.5 million compared to the same period last year. Sales growth excluding the impact of foreign exchange was 21.2 percent.

“Our fourth quarter capped a year of significant progress as we introduced our innovative SAPIEN technology to the U.S.,” said Michael A. Mussallem, chairman and CEO. “We are very proud that more than 5,000 patients in the U.S. have been treated with our transcatheter valves since launch, and we are aggressively investing to expand the availability of this important therapy. In spite of a difficult economic environment, underlying(1) sales were up 16 percent in 2012 driven by a strong finish in each of our product lines.”

Sales Results
For the fourth quarter, the company reported Surgical Heart Valve Therapy product group sales of $197.7 million, which included $29.1 million of cardiac surgery systems sales. Sales grew 3.8 percent over the fourth quarter last year, or 5.5 percent excluding the impact of foreign exchange. Growth outside the U.S. was 4.0 percent, or 7.2 percent excluding the impact of foreign exchange, while sales in the U.S. grew 3.5 percent.

Sales of transcatheter heart valves (THV) were $161.0 million for the quarter, a 72.8 percent growth over the fourth quarter last year, or 77.2 percent excluding the impact of foreign exchange. These results were driven by the ongoing U.S. launch of the SAPIEN valve, with total U.S. THV sales of $80.7 million. Outside the U.S., sales grew by 5.5 percent, or 10.0 percent excluding the impact of foreign exchange.

“We continue to expect underlying transcatheter heart valve sales to grow 30 to 45 percent in 2013. This would result in global sales of $710 million to $790 million, which includes $390 million to $440 million of sales in the U.S.,” Mussallem said.

Critical Care product group sales were $151.8 million for the quarter, including vascular sales of $13.8 million. Critical care sales were $138.0 million, representing growth of 3.5 percent, or 6.0 percent excluding the impact of foreign exchange. Growth was driven primarily by advanced monitoring products in Japan and the U.S.

Domestic and international sales for the fourth quarter were $224.9 million and $285.6 million, respectively.

Additional Operating Results
For the quarter, Edwards’ gross profit margin was 75.4 percent, compared to 72.2 percent in the same period last year. This improvement was driven primarily by a more profitable product mix and the impact from foreign exchange.

Selling, general and administrative expenses were $177.9 million for the quarter, or 34.8 percent of sales, compared to $163.4 million, or 38.0 percent of sales, in the same period last year. The increase in expenses was driven primarily by U.S. transcatheter launch-related investments.

Research and development for the quarter grew 23.4 percent to $74.9 million, or 14.7 percent of sales. This increase was the result of additional investments in clinical studies and new product development efforts in all of the company’s product lines.

Free cash flow for the quarter was $70.6 million, defined as cash flow from operating activities of $126.4 million, less capital spending of $55.8 million.

Cash and cash equivalents and short-term investments were $521.4 million at the end of the quarter. Total debt at December 31, 2012, was $189.3 million.

During the quarter, the company repurchased approximately 2.1 million shares of common stock for $186.9 million. At December 31, 2012, approximately $248 million was available for share repurchase under the company’s existing share repurchase authorization.

Twelve-Month Results
For the twelve months ended December 31, 2012, the company recorded net income of $293.2 million, or $2.48 per diluted share, compared to $236.7 million, or $1.98 per diluted share, for the same period in 2011. On a non-GAAP basis, earnings per diluted share were $2.69, compared to $2.02, a 33.2 percent increase.

Net sales for the twelve months of 2012 increased 13.2 percent to $1.90 billion. Underlying sales growth was 16.2 percent.

Domestic and international sales for the twelve months were $812.1million and $1,087.5 million, respectively.

Free cash flow for the year was $253.1 million, defined as cash flow from operating activities of $373.8 million, less capital spending of $120.7 million.

During 2012, the company repurchased approximately 4.0 million shares of common stock for $353.2 million.

Outlook
“We expect another exciting year for Edwards Lifesciences with continued strong sales growth, greater operating leverage, and progress on a number of important clinical milestones,” Mussallem said. “To strengthen our leadership position we plan to continue investing substantially in the development of transcatheter valves and other structural heart disease therapies, as well as in critical care technologies. We believe our focused innovation strategy, together with our global presence and strong financial footing, uniquely position us to drive strong, sustainable growth, while we help treat additional patients.

“We continue to expect full year sales of $2.1 billion to $2.2 billion and earnings per diluted share, excluding special items, of $3.21 to $3.31,” said Mussallem. “For the first quarter 2013, we project total sales of $505 million to $530 million and diluted earnings per share, excluding the $0.07 benefit from the 2012 R&D tax credit and any other special items, between $0.74 and $0.78.”

SOURCE:

http://www.fiercemedicaldevices.com/press-releases/edwards-lifesciences-reports-strong-fourth-quarter-results?utm_medium=nl&utm_source=internal

History of Edwards Lifesciences

Edwards Lifesciences’ roots date to 1958, when Miles “Lowell” Edwards set out to build the first artificial heart.  Edwards was a 60-year-old, recently retired engineer holding 63 patents in an array of industries, with an entrepreneurial spirit and dreams of helping patients with heart disease. His fascination with healing the heart was sparked in his teens, when he suffered through two bouts of rheumatic fever, which can scar heart valves and eventually cause the organ to fail.

With a background in hydraulics and fuel pump operations, Edwards believed the human heart could be mechanized. However, when he presented the concept to Dr. Albert Starr, a young surgeon at the University of Oregon Medical School, the idea was met with hesitation. Instead, Starr encouraged Edwards to focus first on developing an artificial heart valve, for which there was an immediate need.   After only two years, the first Starr-Edwards mitral valve- which is not longer available for sale – was designed, developed, tested, and successfully placed in a patient. Newspapers around the world reported on what they termed a “miraculous” heart surgery.   This innovation spawned a company, Edwards Laboratories, which set up shop in Santa Ana, Calif. — not far from where Edwards Lifesciences’ global headquarters is located today.

Edwards Lifesciences’ heart valve expertise has led to the development of one of the most exciting opportunities in the cardiovascular field – transcatheter heart valve replacement. The specially-designed valve and delivery system* is being evaluated in clinical studies in which high-risk patients receive a valve replacement without traditional open-heart surgery and while their heart continues to beat. Clinicians replace a patient’s aortic valve via a catheter inserted into a small incision in either the leg or between the ribs. Edwards Lifesciences’ leadership in transcatheter heart valve replacement includes a commitment to rigorous scientific study of the procedure and to extensive clinician training and education.  Consistent with this effort to explore less invasive surgery, the company is committed to providing tools for minimally invasive cardiac surgery that allow cardiac surgeons to perform heart valve operations through small openings, or “ports,” in the spaces between the ribs.

http://cardiovascular.eng.uci.edu/edwardslifesciences/history

In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.)

The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves

This study is currently recruiting participants.

Verified May 2012 by Edwards Lifesciences

First Received on March 7, 2011. Last Updated on May 23, 2012 History of Changes

Sponsor:	Edwards Lifesciences
Information provided by (Responsible Party):	Edwards Lifesciences
ClinicalTrials.gov Identifier:	NCT01314313

Purpose

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems: NovaFlex (transfemoral access) and Ascendra2 (transapical access) in patients with symptomatic, calcific, severe aortic stenosis.

Condition	Intervention	Phase
Symptomatic Severe Aortic Stenosis	Device: TAVR Implantation of the Transcatheter Aortic Valve ProsthesisDevice: AVR with a surgical heart valveDevice: TAVR Implantation of the Transcatheter Aortic Valve ProsthesisDevice: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis	Phase 3

Study Type:	Interventional
Study Design:	Allocation: RandomizedEndpoint Classification: Safety/Efficacy StudyIntervention Model: Parallel AssignmentMasking: Open LabelPrimary Purpose: Treatment
Official Title:	The PARTNER II Trial “Placement of AoRTic TraNscathetER” Valves Trial” (US) [Edwards Study 2010-12]

http://www.clinicaltrials.gov/ct/show/NCT01314313?order=4

Unparalleled Commitment to Research

The research vision for The Edwards Lifesciences Center for Advanced Cardiovascular Technology is a dynamic process and will be developed and implemented by the Center and faculty.

The broad vision will encompass basic research and development of new technologies focused on the treatment of cardiovascular disease.

The breadth of this vision will allow the flexibility to recruit the most outstanding faculty in the cardiovascular field, as well as allow the Center’s research activity to move quickly into new areas while remaining focused in the cardiovascular system. Potential areas of expertise and focus will include, but are not limited to:

Valve replacement technology
Regenerative and degenerative cardiovascular medicine (including tissue engineering and stem cell biology)
Non-invasive (wireless) cardiovascular monitoring, intervention, and imaging
Novel stent or catheter-based therapies including new biological coatings

The engineering expertise that will be applied to these areas include Micro-Electro-Mechanical Systems (MEMS), nanotechnology, biophotonics, biomaterials, systems biology, and computation/modeling.

Core Facilities

The Center has three fully functional core research facilities, and a fourth facility in the final planning stages. The facilities will provide unique and/or synergistic instrumentation and expertise for the campus and community. Access to the core facilities is limited to faculty members who are members of the Center and their trainees. The core facilities are briefly described below, and more information about the instrumentation, access, training, and reservations can be found on each facility’s page:

1. Surgical and Imaging Facility (SIF). The SIF is currently in a planning stage. This facility could potentially provide a major resource to the campus, not only for cardiovascular research, but other organ systems that need small and large animal models, as well as training opportunities for UC Irvine and community-based cardiologists, scientists, or sales representatives from local companies. The planned facility will include the following functionalities:

Complete catheterization including hemodynamic monitoring with bi-plane fluoroscopic imaging

Ultrasound

MicroCT

MicroPET (positron emission tomography)

MicroSPECT (single positron emission computed tomography)

OCT (optical computed tomography)

In addition to the catheterization lab, a fully functional operating room for both acute and chronic procedures are planned.

2. Cell and Tissue Facility (CTF). The Cell and Tissue Facility, located in Engineering Hall rooms 2110 and 2128, is a complete cell-culturing facility. The center offers six biosafety cabinets, two water baths, six CO2 incubators – including one for oxygen tension control – two benchtop incubators – including one for oxygen tension control – centrifuges with refrigeration capabilities, three cell culture microscopes, refrigeration, -80C and -20C freezers, liquid nitrogen storage, and a purified water source.

3. Mechanical Testing Facility (MTF). This core facility provides two basic instruments for investigating mechanical properties. The Synergie 100 system performs tension or compression testing, while the rheometer provides the capability to study dynamic and shear properties. The instruments are housed in Engineering Hall room 2115.

4. Microscopy Core Facility (MCF). Microscopy Core Facility has multiple imaging capabilities, including confocal, fluorescence, differential interference contrast, phase contrast, darkfield, and brightfield microscopy. This core facility is equipped with a Nikon Eclipse TE300 Inverted Scope with Nikon PCM2000 Confocal Attachment, an Inverted Eclipse TE300, and an Upright Eclipse E800 w/ VFM epi-fluorescence attachment. Each microscopy is equipped with a 12-bit CCD camera; specifications can be found on the facility’s website.

http://cardiovascular.eng.uci.edu/book/export/html/12

Executive Compensation in the Cardiology and Cardiac Surgery Medical Devices Market: Comparison of Edwards Lifesciences Corporation with other Suppliers – Analysis of the SAPIEN Contribution

Edwards Lifesciences Corporation

NOTICE OF 2012 ANNUAL MEETING OF STOCKHOLDERS

To be held on Thursday, May 10, 2012

http://ht.edwards.com/sci/edwards/sitecollectionimages/edwards/investorrelations/2012edwardsproxy.pdf

Definition of a Comparator Group for Determination of Executive Compensation. Edwards Lifesciences 2011 Comparator Group include:

Allergan, Inc.

Masimo Corp.

Becton Dickinson & Co.

Medtronic, Inc.

Boston Scientific Corp.

PerkinElmer, Inc.

C. R. Bard, Inc.

ResMed, Inc.

CareFusion, Inc.

St. Jude Medical, Inc.

Covidien plc

Stryker Corp.

Gen-Probe, Inc.

Thoratec Corp.

Hospira, Inc.

Varian Medical Systems, Inc.

Illumina, Inc.

Zimmer Holdings, Inc.

Integra Lifesciences Holding Corp.

http://ht.edwards.com/sci/edwards/sitecollectionimages/edwards/investorrelations/2012edwardsproxy.pdf

p.28

In the Chairman of the board address: 2011 Performance was Strong. The year 2011 was one of significant investment and major milestones. Successful PARTNER trial results culminated in U.S. regulatory approval to begin commercially offering the SAPIEN transcatheter heart valve to many inoperable patients. We developed a rigorous training program to promote the teamwork of cardiac surgeons and interventional cardiologists, and to emphasize excellent clinicalresults. To support expected growth, we expanded our heart valve manufacturing capacity, and made additional enhancements to our infrastructure, including our information and quality systems.As a result of the combined efforts of our management team and their employees, in 2011, theCompany delivered another year of strong financial performance. The company-wide financial measures usedto determine 2011 incentive compensation consisted of goals for revenue growth, net income, and free cashflow.

The following table shows the 2011 results for these three metrics compared against the 2011 targets and the comparable performance measures for 2010 and 2009:

2011 2011 2010 2009

Actual Target Actual Actual

Revenue Growth* . . . . . . . . . . . . . . . . . . . . . 11.0%** 11.4%** 12.7% 11.4%

Net Income* . . . . . . . . . . . . . . . . . . . . . . . . $259.6** $244.0** $218.9 $181.5

Free Cash Flow* . . . . . . . . . . . . . . . . . . . . . $215.0** $215.0** $196.2 $178.1

http://ht.edwards.com/sci/edwards/sitecollectionimages/edwards/investorrelations/2012edwardsproxy.pdf

p.25

	Comparison of Cumulative Five Year Total Stock Return
	2007	2008	2009	2010	2011
Edwards Life Sciences	98	117	185	344	301
S&P	104	64	79	89	89
Morgan Stanley Health Care Products	103	82	102	109	115
http://ht.edwards.com/sci/edwards/sitecollectionimages/edwards/investorrelations/2012edwardsproxy.pdf p.26

Pay for Performance Philosophy.The Compensation Committee strongly believes that executive compensation should be tied to performance and strives to create a pay for performance culture. Our compensation objectives are to offer programs that emphasize performance-based compensation and align the financial interests of our executives with those of the Company’s stockholders. Accordingly, approximately 80% of the total direct compensation of our Chairman of the Board and Chief Executive Officer (the ‘‘Chairman and CEO’’) and our Named Executive Officers is at risk based upon the performance of the Company. p.26

Company	CEO TDC (Average) (in thousands)
Company	Most Recent FY	Last 3 FYs	Last 5 FYs
2011 Comparatoe Group
90th Percentile	$10,627	$11,110	$10,398
75th Percentile	$9,590	$10,012	$9,143
Median	$7,839	$7,748	$7,836
25th Percentile	$5,011	$5,008	$5,228
Edwadrs Lifesciences	$5,829	$5,789	$5,567
Percentile	36.60%	33.90%	26.60%
http://ht.edwards.com/sci/edwards/sitecollectionimages/edwards/investorrelations/2012edwardsproxy.pdf p.29

When compared to the competitive data based on the 2011 Comparator Group, the average base salary compensation paid to the Named Executive Officers for the 2011 fiscal year was approximately 2.5% below the median, the total cash compensation was at the median, and total direct compensation was approximately at the median. The following chart illustrates the total direct compensation of our Chairman and CEO.

The total stockholder return (TSR) for the Company’s common stock for the previous one, three, and five years, compared to the data of our 2011 Comparator Group:

2011 Edwards Most Recent Return: -11.8%, 42 percentile

Last 3 FYs 55.6%, maximum percentile

Last 5 FYs 37.3%, maximum percentile

2011 Comparator Group: 90^th percentile subgroup, Most Recent TSR 7.6%

Last 3 FYs 18.9%

Last 5 FYs 8.5%

Executive compensation at Edwards in 2012 will increase significantly as a direct results from the Edwards’ stock soars after FDA panel nod on expanded Sapien valve use

On June 14, 2012:

Stock Price and Trading Volume 7/2011 to 6/14/2012

http://www.dailyfinance.com/quote/nyse/edwards-lifesciences-corp/ew/charts

Stock Price and Trading Volume 5/21/2012 to 6/14/2012

http://www.dailyfinance.com/quote/nyse/edwards-lifesciences-corp/ew/charts

Edwards Lifesciences Corp. (EW) won the backing of U.S. advisers for an expanded use of the company’s Sapien heart valve as an alternative to open-heart surgery. Edwards’ transcatheter aortic heart valve may soon have two indications: for aortic stenosis patients who are both inoperable and at high risk for surgery.

Smith, PARTNER trial’s principal investigator of Cohort A during the sponsor presentation, urged that the higher frequency of neurological events that occurred within the TAVR group should not be “trivialized” in either treatment group. Smith called aortic stenosis “one of the conditions we understand best in cardiovascular disease.” He called transcatheter aortic valve replacement (TAVR) a “miracle therapy,” and said that outcomes for the procedure will only continue to improve. And while most of the day’s conversation gave kudos to the PARTNER trial and its findings, concerns did focus on gender differences and neurological events.

Mark Hollmer explains that Edwards Lifesciences ($EW) scored a major win on Wednesday, successfully making its case before an FDA panel of experts that its Sapien transcatheter heart valve should be used in a broader class of patients. The agency’s Circulatory Systems Advisory Committee voted 11-0 (one panelist abstained) that the benefits outweighed any risks in using the valve for patients with severe aortic stenosis who are high-risk but could otherwise undergo surgery.

Investors reacted favorably, driving Edwards’ stock up more than 8% to $98.55 by midday on June 14. Bloomberg, MedPage Today, The Associated Press, CardiovascularBusiness and many others covered the day-long panel meeting and final vote. While the FDA doesn’t have to follow the panel’s recommendation, it usually does. Panel members also voted 12-0 that Sapien is effective and 10-2 that the valve is safe.

When the FDA comes out with its final decision is anyone’s guess, but Bloomberg predicts final action could come in October, based on the timeline for Sapien’s initial approval in 2011 (panel meeting in July; regulatory approval in November). Sapien initially gained FDA approval for patients with limited classes of stenosis who can’t have surgery.

To make its case during the 8-hour-plus hearing, Edwards Life Sciences relied on the “Cohort B” part of its pivotal PARTNER trial, which compared transcatheter aortic valve implantation (TAVI) with surgery. (“Cohort A” was used for the initial approval in November.) PARTNER recruited 699 high-risk older patients with severe aortic stenosis and randomly assigned them to TAVI (n=348) or surgery. About two-thirds of the TAVI patients underwent transfemoral procedures, where the device was threaded through the femoral artery, while 103 had transapical access procedures, where the device was inserted directly into the tip of the left ventricle of the heart.

Death rates were essentially the same at 1 year for the Sapien group and the control group. When divided up by type of valve implantation compared with matched surgery controls, the death rate for Sapien implanted via a transfemoral approach was 24.2% versus 26.8% for surgery; and for the transapical approach the 1-year mortality rate was 22.2% for the Sapien group and 26.4% for the open-heart surgery group. Although the death rate was very similar, TAVI patients had double the rate of stoke during the 30-day period following the procedure. With the transapical approach, there appeared to be an even greater increased risk for early stroke, which the panel chalked up to the fact that patients who received TAVI via transapical approach were sicker patients, so their outcomes were poorer than those who were implanted via a transfemoral approach.

The trial involved 699 older patients of high risk with severe aortic stenosis who were randomly assigned to the TAVI procedure or surgery. Among the findings: the death rate was similar for both, but patients who had transcatheter aortic valve implantation faced double the rate of stroke over the initial 30-day period after the surgery. That finding concerned both FDA scientists and panel members, though Edwards countered that stroke rates evened out after another year, Bloomberg notes. Regulators in advance of the hearing were also bothered by how the company chose patients and categorized them for the trial, arguing that it constituted bias to some degree, and potentially skewed the results.

Edwards wants to do a post-approval study to follow patients from the trial and also create a registry to enroll new patients. FDA staff members agree, and urged at least 5 years of follow-up for subjects from the trial.

http://www.fiercemedicaldevices.com/story/edwards-lifesciences-argue-expanded-sapien-valve-use/2012-06-12?utm_medium=nl&utm_source=internal

http://www.medpagetoday.com/Cardiology/PCI/33263

Transcatheter Heart Valve Replacement Market: A Market of $2.5 Billion in the US

The market for transcatheter valves may total $2.5 billion in the U.S., said Jason Mills, a San Francisco-based analyst with Canaccord Adams Inc. The initial FDA approval of Sapien in November boosted Edwards’s sales 67 percent in the first quarter to $122 million, Michael Mussallem, the company’s chairman and chief executive officer, said in an April 24 earnings call.

The device is meant to treat aortic stenosis. The debilitating condition is caused by a narrowing valve that restricts the ability of blood to enter the aorta, the main artery that carries blood from the heart, according to the National Institutes of Health.

“A broader indication for high-risk patients would enable multidisciplinary heart teams to choose the approach best suited to their patients’ needs,” Mussallem said in a statement after the panel’s vote. “We look forward to working closely with the FDA during the review process, and thank the panel for their thoughtful analysis.”

The FDA may decide on approval in October if reviewers follow the same timeline they did when they cleared the valve for inoperable patients. Advisers met in July to consider the device for inoperable patients and approved it in November.

http://www.cardiovascularbusiness.com/index.php?option=com_articles&view=article&id=34321:sapien-makes-more-headway-in-aortic-stenosis-world

Another point of concern, as Bloomberg points out: FDA staff noted that patients treated with Sapien faced twice the stroke risk in the initial month after the implant procedure, compared to patients who had open-heart surgery instead.

The FDA wants the company to commit to a long-term follow up, post-approval study that tracks patients for at least 5 years to address its concerns. Edwards appears to be on the same page, having proposed a post-approval study that would follow patients from its pivotal trial, as well as a new patient registry, according to the story.

http://www.fiercemedicaldevices.com/story/edwards-lifesciences-argue-expanded-sapien-valve-use/2012-06-12?utm_medium=nl&utm_source=internal

Edwards won a PMA for the Sapien device for inoperable patients with aortic stenosis, a hardening and narrowing of the aortic valve, in November 2011.* FDA reviewers said the arm of the study covering the high-risk patients may have been flawed by the inconsistencies.

“FDA notes that screening and subsequent enrollment practices were not homogenous. The large variation between the ratios of those screened to those enrolled may represent different selection criteria among sites,” according to documents released ahead of the meeting scheduled for Wednesday. “Enrollment practices related to identification of ‘inoperable’ and ‘high risk’ patients were not homogenous across sites.”

https://www.massdevice.com/news/fda-possible-selection-bias-issues-confound-edwards-sapien-study

FDA Panel

There was “no significant difference” in mortality between patients treated with surgery vs. treatment with the Sapien valve, according to the documents. But some patients who were slated for traditional open heart surgery were treated with the TAVI device, and vice-versa, making it difficult to evaluate the study’s endpoints.

“[T]he issue of [surgery] patients not receiving [surgery], [Sapien] patients receiving [surgery], and [surgery] patients undergoing concomitant operations makes evaluation of these endpoint results difficult,” according to the FDA reviewers. “Although the primary endpoint was met, issues related to potential selection bias confound the interpretation of these results.”

“We believe the Partner trial was well-designed and executed. We are proud of the efforts of the leading heart teams that supported this ground-breaking trial and what it means for patients,” an Edwards spokeswoman told MassDevice.com via email. “We are reserving further comment on this or related matters until the Advisory Committee scheduled for June 13.”

The FDA also wants the circulatory devices panel to consider better ways to construct future trials of similar devices and to come up with appropriate endpoints for a post-market surveillance study. The panel is scheduled to vote on whether the device is as safe and effective as surgery and whether its benefits outweigh its risks for the high-risk cohort.

https://www.massdevice.com/news/fda-possible-selection-bias-issues-confound-edwards-sapien-study?page=2

Medicare to Cover Edwards’ Sapien Heart Valve

On May 2, 2012 Mark Hollmer reported that for medical device companies, gaining Medicare reimbursement for surgical procedures involving their implants can be a sort of financial holy grail. After all, an implant won’t be used much if the cost can’t be covered. Edwards Lifesciences ($EW) has reached that point now that the Centers for Medicare & Medicaid Services has agreed to pay for surgery involving its Sapien transcatheter heart valve. Ssince Sapien’s U.S. debut in November. As a result, sales should get a boost, Wells Fargo analyst Larry Biegelsen said, as quoted by Bloomberg in its coverage of the news.

Specifically, CMS approved reimbursement of transcatheter aortic valve replacement therapy when the device is used to treat symptomatic aortic valve stenosis. The coverage determination is flexible and authorizes current and future FDA approved indications, the company notes, as well as coverage for clinical studies.

About 300,000 U.S. patients suffer from deterioration of the aortic heart valve, which forces the heart to work harder to pump blood, often leading to heart failure, blood clots and sudden death. More than half of patients diagnosed with the condition, called aortic stenosis, die within two years, according to the FDA. Every year about 50,000 people in the U.S. undergo open-heart surgery to replace the valve, which involves sawing the breastbone in half, stopping the heart, cutting out the old valve and sewing a new one into place. Thousands of other patients are turned away, deemed too old or ill to survive the operation.

The Sapien valve is usually threaded through the femoral artery via a small incision in the leg, and then guided up to the heart via catheter. An alternate procedure inserts the valve through a small incision between the ribs. The valve is then wedged into the aortic opening by an inflatable balloon, replacing the natural heart valve. The device is made from cow tissue and polyester supported by a steel frame.

Analysts estimate as many as 70,000 to 100,000 patients per year could eventually receive the valve. In the most recent quarter Edwards reported Sapien sales of $121.5 million, with the U.S. contributing $41 million. For the full year Edwards expects sales of $530 million to $600 million.

http://www.mercurynews.com/business/ci_20850361/fda-panel-backs-broader-use-edwards-heart-valve

eBook: Waiting for Guidelines Will FDA take the reins of laboratory-developed tests?

Two cardiac surgeons must independently evaluate the patient first, and hospitals offering the procedure must have an on-site heart valve surgery program, plus a cardiac catheterization lab or a lab/operating room hybrid with appropriate imaging systems. And as Bloomberg points out, the guidelines limit who can conduct the procedure to a multidisciplinary team of doctors that must include at least one heart surgeon and interventional cardiologist. And those experts must perform the surgery at least 20 times annually to remain certified.

CMS also requires the heart team and hospital to take part in a post-surgery clinical trial, a national registry that follows patients who have the procedure for at least one year. This study will look at variables including strokes, death, heart attacks, kidney injuries, any repeat procedures and overall quality of life.

Sapien, generated $41 million in sales during the first quarter, the first full quarter the device has been on the market.

http://www.fiercemedicaldevices.com/story/medicare-cover-edwards-sapien-heart-valve/2012-05-02?utm_medium=nl&utm_source=internal

June 13, 2012 – FDA panel votes in favor of Sapien valve. The FDA’s Circulatory System Devices Committee gave Edwards Lifesciences ($EW) a win Wednesday with a vote recommending the devicemaker’s Sapien transcatheter heart valve after an epic session. The panel voted 9-0–with one member abstaining–that the device’s benefits outweighed its risks, 7-3 in favor of its safety, and 9-1 for its effectiveness. The FDA will make a decision on the valve at a later date.

Earlier in the week, the FDA released a report showing the valve, which can be implanted without major surgery, significantly reduced death rates versus standard therapy in people with severe aortic stenosis. However, there was a higher incidence of major strokes and major vascular events seen in the group receiving the Sapien valve in a study.

Indeed, neurological events represented a major issue in the meeting, as heartwire notes, with several panel members pointing out that older, frail patients are far more concerned about strokes than death. Furthermore, mortality reduction with TAVI is, as the FDA terms it, impressive, but most treated patients die within two years. That said, panel members concluded that the benefits of transcatheter valve replacement in these frail patients offset the stroke risk.

“We are pleased with the panel’s strong recommendation for approval, and would like to thank them for their comprehensive and thoughtful review of the data presented from The PARTNER Trial. This represents another important step on the path to what we hope will lead to FDA approval of SAPIEN,” Michael Mussallem, Edwards’ chairman and CEO, says in a statement. “We would also like to thank the principal investigators and their heart teams at the PARTNER hospitals for their dedication to this clinical trial, and to their patients for participating in a study of a new therapy.”

Edwards has marketed Sapien in Europe since 2007 and could start selling it in the U.S. in Q4, 2012. Analysts note the worldwide market for heart valves could ultimately grow to $2 billion in annual sales, as the Orange County Business Journal reports.

http://www.fiercemedicaldevices.com/story/fda-panel-votes-favor-sapien-valve/2011-07-20

The valve SAPIEN is currently approved for patients who aren’t healthy enough to undergo the more invasive open-heart surgery, which has been used to replace the aortic valve for decades. On June 13, 2012 – the implant is approved for patients who are healthier, but still face serious risks from chest-opening surgery. Many such patients are in their 80s and have complicating medical factors like diabetes.

Irvine, Calif.-based Edwards plans to conduct two follow-up studies to evaluate long-term safety as well as differences in gender outcomes per FDA panel on June 13, 2012.

Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N)

The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED) with the following conditions described in

http://pharmaceuticalintelligence.com/2012/06/19/the-centers-for-medicare-medicaid-services-cms-covers-transcatheter-aortic-valve-replacement-tavr-under-coverage-with-evidence-development-ced/

CONCLUSIONS

The Pay for Performance Philosophy at Edwards Lifesciences will support a substantial reward for the Chairman and CEO in 2012. His $5.8 Million in total compensation in 2011, occurred for a average of Five Year Total Stockholders Return of 301% while at the same time S&P delivered an anemic Five Year Total Stock Return of 89% per 2011 Edwards Most Recent Return: -11.8%, 42 percentile as reported in 2011 Edwards Annual Report. With the potential of EW symbol exceeding $100 per share in the second half of 2012, CEOs total compensation may move Edwards from the 36 percentile to the median in the Comparator Group selected for determination of Executive compensation at Edwards. . In the most recent quarter Edwards reported Sapien sales of $121.5 million, with the U.S. contributing $41 million. For the full year Edwards expects sales of $530 million to $600 million.

FDA’s broadening definition of patients eligible for TAVR to include other patients than the ones with aortic stenosis that can’t undergo open heart surgery, will have an immediate effect on the total cost that these procedures will bear by having the procedure been covered by Medicare and Medicaid. An increase in the Healthcare cost and its National burden is expected. Analysts estimate as many as 70,000 to 100,000 patients per year could eventually receive the valve.

The Procedure will have a major improvement in the quality of life of patients undergoing TAVR with a favorable impact on their longevity.

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Treatment of Refractory Hypertension via Percutaneous Renal Denervation

Posted in Cardiac & Vascular Repair Tools Subsegment, Ecosystems & Industrial Concentration in the Medical Device Sector, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, HTN, Massachusetts Niche Suppliers and National Leaders, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Pharmacotherapy of Cardiovascular Disease, Renal Denervation, tagged American Heart Association, Blood pressure, Boston Scientific, Cardiosonic, Cleveland Clinic, Covidien, Hypertension, Inc., Kona Medical, Medtronic, Mercator MedSystems, Millennium Research Group, ReCor Medical, Renal denervation medical devices, Renal denervation procedure, St. Jude, Vessix Vascular on June 13, 2012| 15 Comments »

Treatment of Refractory Hypertension via Percutaneous Renal Denervation

Curator: Aviva Lev-Ari, PhD, RN

UPDATED 8/5/2013

VIEW VIDEO – Editorial the Heart.org

Renal denervation: Clinical lessons from around the world

Renal Denervation treatment represents a medical subfield, it has its roots in surgical sympathectomy techniques dating back to the 1930s. This radical approach to blood pressure control, which did not specifically target renal nerves, was ultimately abandoned due to associated perioperative complications. However, experience in renal transplantation, a procedure in which the renal nerves are selectively severed, suggests that the denervated kidney can maintain volume and electrolyte homeostasis.

http://ajpregu.physiology.org/content/298/2/R245.full

http://www.ncbi.nlm.nih.gov/pubmed/3326559?dopt=Abstract

Potential effects of renal denervation are on improved glucose control, sleep apnea, and treatment of heart failure syndromes and renal dysfunction – all consequences of sustained hypersympathetic activity.

Based on these observations, the specific targeting of renal nerves as a major operative in the pathophysiology of hypertension and other conditions associated with increased sympathetic activity (renal dysfunction and heart failure) appears to be an attractive therapeutic approach.

http://bmctoday.net/evtoday/2012/02/article.asp?f=renal-artery-denervation-a-brave-new-frontier

A new therapeutic paradigm of percutaneous renal artery denervation using the application of radiofrequency (RF) energy (Symplicity renal denervation system [Ardian, acquired by Medtronic, Inc., Minneapolis, MN]) has recently been demonstrated to be safe, effective, and durable in significantly reducing systolic blood pressure in patients with resistant hypertension.

This new technology represents the first time that physicians have been able to target renal nerves specifically via a catheter-based intervention. This endovascular approach opens the door to better understanding the relationship between sympathetic hyperactivity and hypertension.

Current therapeutic strategies center on lifestyle changes and pharmacologic interventions; however, the rates of blood pressure control and therapeutic efforts to reduce the rate of progression of hypertensive end-organ damage (resulting in myocardial infarction, stroke, and renal dysfunction) remain a neglected priority.

http://rd.springer.com/article/10.1007/s11906-010-0119-1

Renal denervation is used to treat uncontrolled hypertension, or high blood pressure, by the ablation of the nerves that line the renal arteries using a catheter. The Cleveland Clinic called renal denervation the No. 1 healthcare innovation of 2012. More than 12 million patients worldwide whose blood pressure remains uncontrolled despite taking three or more anti-hypertensive medications representing a global market opportunity for renal denervation that could ultimately grow to $30 billion. The Millennium Research Group estimates that the hypertension-treating devices could generate $4.4 billion per year, Bloomberg reported. That number could swell if the FDA indicates the systems for simple hypertension and not just the drug-resistant sort. As Bloomberg notes, a boom in hypertension devices would be a welcome development for the device industry, which has struggled over the past four years with recalls, litigation and regulatory woes, leading to a 7% decline in Standard & Poor’s Healthcare Equipment Index.

“At least 23 companies, mainly smaller, private companies are developing products,” Wang said, based on information she gathered at the American College of Cardiology Conference in Chicago in March.

http://medcitynews.com/2012/04/medtronic-aside-a-whole-host-of-firms-chasing-hypertension-market/

http://www.fiercemedicaldevices.com/story/bloomberg-hypertension-devices-could-pay-big-us/2012-05-25?utm_medium=nl&utm_source=internal

According to the American Heart Association, a 5 mm Hg (millimeters of mercury) reduction in systolic blood pressure results in a 14 percent decrease in stroke, a 9 percent decrease in heart disease, and a 7 percent decrease in overall mortality. Renal denervation has shown in clinical studies to be safe, durable and effective in reducing systolic blood pressure by as much as 20 percent.

Numerous analysts suggest that there are more than 12 million patients worldwide whose blood pressure remains uncontrolled, despite taking three or more anti-hypertensive medications. This represents a global market opportunity for renal denervation approaching $30 billion.

Procedure Benefits

Hypertension, though often asymptomatic, is the number one risk factor for premature death worldwide.¹ Renal Denervation (RDN) treatment aims to address this condition at its source to provide a substantial and durable reduction in blood pressure. After the procedure, people can often return to their normal activities quickly. The benefit is often achieved after several weeks to months.

Benefits and New Indications for Usage of Intravascular Stimulation/Ablation of Autonomics

1. Reduction in Heart Rate and Heart Rate Variability

Dr. Scherlag experiments noted changes in heart rate which have also been reported in SYMPLICITY HTN-1 and SYMPLICITY HTN-2 (8-9). The SYMPLICITY HTN-2 study demonstrated profound bradycardia in 13% of patients that was treated with atropine.

The intra-procedure effect on heart rate during renal artery denervation documented in the SYMPLICITY trials is also manifest long term by measuring heart rate variability (10). Indeed, cardiac effects would be expected with autonomic modulation. Besides the two example above showing that cardiac sympathetic denervation effects heart rate, there are many more that are just beginning to be reported in the literature.

These articles shows the effects of renal denervation on heart rate.

http://www.ncbi.nlm.nih.gov/pubmed/1735574
http://www.ncbi.nlm.nih.gov/pubmed/8777835

A Cleveland Clinic review article states: “Additionally, the resting heart rate was lower and heart rate recovery after exercise improved after the procedure, particularly in patients without diabetes.”
http://www.ccjm.org/content/79/7/501.full

2. Renal Sympathetic Denervation lowers Atrial Fibrillation

This article discusses the effect of renal sympathetic denervation on atrial fibrillation.

http://www.ncbi.nlm.nih.gov/pubmed/22585944

3. Regression of Left Ventricular Hypertrophy, Increase in Ejection Fraction (EF) and improved Diastolic Dysfunction

“Brandt reported regression of left ventricular hypertrophy and significantly improved cardiac functional parameters, including increase in ejection fraction and improved diastolic dysfunction, in a study of 46 patients who underwent renal denervation. This findings suggests a potential beneficial effect on cardiac remodeling.” (Brandt MC, Mahfoud F, Reda S, et al. Renal sympathetic denervation reduces left ventricular hypertrophy and improves cardiac function in patients with resistant hypertension. J Am Coll Cardiol 2012; 59:901–909)

4. Reduction in Ventricular Tachyarrhythmias (VT)

“Ukena reported reduction in ventricular tachyarrhythmias in two patients with congestive heart failure who had therapy-resistant electrical storm.” (Ukena C, Bauer A, Mahfoud F, et al. Renal sympathetic denervation for treatment of electrical storm: first-inman experience. Clin Res Cardiol 2012; 101:63–67)

5. Intravascular Stimulation of Autonomics Effects on Heart Failure

The most recent data from Europe shows the following effects on heart failure:

http://www.eurekalert.org/pub_releases/2012-08/esoc-rdg082712.php
http://www.theheart.org/article/1364267.do

Dr. Scherlag, writes, [N]early ten examples of the effects of “CARDIAC SYMPATHETIC DENERVATION” and what are the effects on the kidney?

No change in GFR. No change in creatinine.

http://pharmaceuticalintelligence.com/2012/09/02/imbalance-of-autonomic-tone-the-promise-of-intravascular-stimulation-of-autonomics/

Procedure Risks

Although major complications are uncommon, RDN treatment carries many of the same risks as an angioplasty procedure for the treatment of artery disease. The catheter insertion site could become infected, become bruised or bleed heavily. Other possible complications include heart attack, stroke, kidney damage or malfunction, heart rhythm disturbances, arterial damage, hypotension, sudden cardiac death, burns and pain. Imaging agents, pain medications and anti-spasm agents are commonly used during the procedure and carry known risks.

1. Mathers, C., et al. World Health Organization; 2009

http://www.ardian.com/ous/patients/benefits-risks.shtml

Medical Debate on the Procedure – The candidates are hypertensive patients receiving blood-pressure-lowering medication that are truly “resistant.”

The Symplicity system (Medtronic) is the far-and-away front runner, having demonstrated average office-based BP drops of 32/12 mm Hg at six months in the SYMPLICITY HTN 2 trial, as reported by heartwire, with 84% of patients having had a >10-mm-Hg drop in systolic blood pressure from baseline.

Upwards of 20 other companies, according to Dr Ron Waksman (Washington Hospital, DC), are busy developing competing systems, some of which were featured in a EuroPCR session devoted to emerging technologies in May 2012 in Paris.

Leading this pack is St Jude’s EnligHTN system, which received CE Mark on the opening day of the meeting. Dr Stephen Worthley (Royal Adelaide Hospital, Australia) presented 30-day results in 47 resistant-hypertension patients treated with the multielectrode, RF-ablation-based system. Mean office BP changes at one month in EnligHTN 1 were -28 systolic and -10 diastolic (p<0.0001 from baseline), with 78% of patients having systolic BP drops of >10 mm Hg.

https://www.massdevice.com/news/europcr-st-judes-enlightn-lowers-blood-pressure-faster-rival-systems

In terms of safety, no serious complications were seen in the renal artery or at the access site in the EnligHTN study; minor procedure-related events included four hematomas, three vasovagal responses to sheath removal, and two postprocedure transient bradycardias.

Other devices featured in the session included a second RF-energy system and two ultrasound systems, see below technology description by supplier.

The risk of cardiovascular death doubles with every 20 point increase in systolic blood pressure, so an average blood pressure reduction of 28 points is quite significant and demonstrates just how effective the technology is. Principal investigator Prof. Stephen Worthley said in prepared remarks. “From other clinical trials studying the impact of renal denervation we have learned that blood pressure continues to be reduced over time, so I would not be surprised to see this trend continue and see an even greater benefit for patients.” St. Jude’s study included 47 patients with high blood pressure that wasn’t managed with drug therapy. Participants had an average of 176/96 mmHg baseline blood pressure, despite taking multiple medications, before the denervation procedure and an average of 148/87 mmHg after. More than 40% had systolic rates below 140 mmHg.

http://investors.sjm.com/phoenix.zhtml?c=73836&p=irol-newsArticle&ID=1695802

Interventionalists who spoke with heartwire were unvaryingly excited about the potential of renal denervation, with some caveats.

“You need enthusiasm to develop new things, and in hypertension we haven’t seen an innovation in decades,” Dr Thomas Lüscher (University Hospital Zürich, Switzerland) told heartwire. “So just the possibility that you would be able to have a persistent treatment effect by a procedure that helps severe hypertension patients and maybe in the future even the option to cure hypertension is very exciting indeed. But I agree it’s a dream at this point. I think we need the SYMPLICITY HTN 3 trial, which hopefully will confirm what the other studies have shown.”

Now enrolling at as many as 90 US centers, SYMPLICITY HTN 3, Lüscher pointed out, has design characteristics addressing two concerns with the earlier trials, namely a sham procedure for the control group and ambulatory blood-pressure monitoring in all patients.

During the same emerging-technologies session, Lüscher explored the albeit-scant data supporting a role for renal denervation in other conditions: everything from metabolic syndrome and obstructive sleep apnea to heart failure, atrial fibrillation, and polycystic-ovary syndrome.

But his counterpoint, Dr Jean Renkin (UCL St Luc University Hospital, Brussels, Belgium), was skeptical, pointing to the myriad unanswered questions with the technology.

“Currently, reasonably solid data are available only for patients with hypertension resistant to pharmacotherapy, which cannot necessarily be extrapolated to other forms of hypertension or conditions referred to [by Dr Lüscher]. However, at this point in time, no clouds have appeared in the sky, so let us dream on.”

Dr Renkin had one staggering number for the audience to consider: of 5000 patients who have undergone renal denervation, only 250 were actually treated as part of clinical studies. While no device has US approval, five denervation systems already hold CE Mark in Europe and are being used with increasing frequency.

Treating the Truly Medication Treatment “Resistant”

For a comprehensive presentation of Triple Antihypertensive Combination Therapy Significantly Lowers Blood Pressure in Hard-to-Treat Patients with Hypertension and Diabetes, refer to

http://pharmaceuticalintelligence.com/2012/05/29/445/

Another talking point is the proportion of patients who are truly “resistant.” The number agreed on by Lüscher, Waksman, and session comoderator Dr Robert Whitbourn (St Vincent’s Hospital, Fitzroy, Australia) was that just 3% of all hypertensive patients receiving blood-pressure-lowering medication are truly “resistant.” Numbers as high as 30% have been suggested in other reports, he noted.

“Interestingly, when we’ve been involved in various trials, every cardiologist says they have hundreds of these patients, but when we actually go to get them, no one actually has any,” Whitbourn quipped. “I think it should be a sobering thought—the numbers are actually quite small.”

Dr William Wijns (Cardiovascular Center Aalst, Belgium), also speaking with heartwire, agreed that the subset was “small” but argued it was “still big numbers, millions of people,” and “a massive unmet need.”

Waksman, insisting he was “excited” by what he called “robust reductions in blood pressure,” nevertheless urged eager interventionalists to work with hypertension experts and resist the urge “to jump on patients before we truly verify that they are resistant to medical treatment.”

In the vast majority of people even for whom renal denervation is appropriate, it “won’t be a cure,” Waksman said. “Most of these patients will have to continue on medical treatment—this is not replacing medical treatment, it is just getting [patients] more in control.”

http://www.theheart.org/article/1402321/print.do

The Global Supplier Ecosystem for Renal Denervation Systems

US Campbell, CA Kona Medical is attempting to address these limitations. The system delivers energy from outside the patient to the renal nerves. Ultimately, the procedure will be a “no puncture,” noninvasive technique, compatible with technologies that will allow for temperature and lesion mapping. A noninvasive procedure will allow titration of the therapy— that is, the application of patient-specific dose fractions while monitoring therapeutic effect in between fractions. The basis of the technology is focused ultrasound, not high intensity (HIFU) as one might see and expect in the treatment of tumors, but low-intensity focused ultrasound (LIFU). The biologic underpinnings of this treatment are described in past literature for treating nerves using ultrasound. Kona noninvasive system. The system is depicted in a custom chair; another version of the system is compatible with a standard fluoroscopy or MRI table. Both ultrasound (through elastography and the evolution of temperature mapping and MRI) allow further imaging and analysis of the treatment area. The dose distribution surrounding the artery is that of an annular ring around the wall of the artery. Kona has shown in animal studies that a heat/vibratory cloud at one plane along the artery is highly effective at long-term inhibition of renal nerves with no visible effect on any portion of the artery at any time point.

US, Ronkonkoma, NY & Germany – Paradise by ReCor Medical 6-F compatible catheter with a cylindrical transducer that emits ultrasound energy circumferentially, allowing for a more efficient renal denervation procedure First-in-human (15 patients at 3 months) BP drop, mm Hg -32/-16 at 3 mo. The ultrasound transducer lies within a low-pressure balloon that allows for self-centering of the transducer and gentle contact with the artery wall for uniform circumferential denervation. This means that nerves below the surface of the artery wall are damaged in 360° with a single emission. The balloon also enables cooled fluid to circulate during the energy delivery process, thereby cooling the endothelial wall and protecting it from any excessive heating that could be caused by other energy sources or designs. Preliminary F-I-M clinical data for PARADISE were reported previously at the “TRenD 2012” transcatheter renal denervation scientific meeting by cardiologist Thomas A. Mabin, M.D., Vergelegen Medi-Clinic, South Africa. The updated PARADISE data show that systolic blood pressure was reduced by a statistically significant average of 36 mm Hg in 8 patients at 90-days follow-up. The scientific literature demonstrates that only a 5 mm Hg reduction in BP results in a 14% decrease in stroke, a 9% decrease in heart disease, and a 7% decrease in mortality.

US, San Leandro, CA The Mercator Bullfrog by Mercator MedSystems, Inc. is a catheter-guided system designed to inject therapeutic agents directly, nonsystemically, and safely through blood vessel walls into adventitial tissues and has received US Food and Drug Administration 510(k) clearance. The Bullfrog catheter is tipped with a balloon-sheathed microneedle and is guided and inflated in a manner similar to an angioplasty catheter but with far lower expansion pressures (2 atm vs 6–20 atm) in vessels of 3 to 6 mm in diameter. It is compatible with 0.014-inch guidewires and 6-F introducer sheaths. When the desired injection site is reached, the balloon is inflated with saline and radiopaque contrast, securing the system for injection and sliding the microneedle through the vessel wall. Nonclinical studies have shown that the Bullfrog catheter is able to deliver up to 5 mL per injection into the renal artery adventitia with no apparent safety concerns. Guanethidine Ismelin) is delivered to the renal artery adventitia to accomplish sympathetic denervation. Given locally, guanethidine is known to induce an autonomic denervation directly and through an immune-mediated pathway. Mercator’s preclinical experiments have shown that guanethidine, injected at appropriate concentrations into the adventitial space around renal arteries, selectively ablates the nerves in the adventitia around the renal artery after a single, 20-minute procedure

J Neurosci. 1983;3:714-724

US – Laguna Hills, CA – V² Radiofrequency Baloon by Vessix Vascular, Inc. Bipolar RF balloon catheter REDUCE-HTN pilot (10 patients)

BP drop, mm Hg -30/-11 at 1 mo V ² catheter, a patented noncompliant balloon catheter with RF electrodes and thermistors mounted on the exterior of the balloon, and the proprietary V ² bipolar RF generator. Once inserted into the renal artery, a 30-second inflation/treatment per renal artery delivers simultaneous RF therapy with independent temperature control to all electrode pairs. V ² catheter is available in balloon diameters ranging from 4 to 7 mm, with a balloon length of 25 mm. Larger-diameter balloons have eight electrode pairs, and smaller-diameter balloons have four to six electrode pairs made of solid gold, which are biocompatible and facilitate good electrode contact with the renal arterial wall. In addition, the electrodes are radiopaque, allowing the V ² catheter to be easily visualized under fluoroscopy. Beginning in the first quarter of 2012, the V 2 renal denervation system will be utilized in the company’s first international, multicenter clinical study: REDUCEHTN.

Israel, Tel Aviv – Tivus by Cardiosonic A6-F transducer-tipped catheter, ultrasound energy (Animal data only) The solution for renal denervation is a high-intensity, nonfocused ultrasonic (US) catheter system named TIVUS (Therapeutic IntraVascular UltraSound) (Figure 3). By applying ultrasonic energy, the TIVUS technology enables remote, localized, controlled, and repeatable thermal modulation of the renal vessel wall tissue, resulting in safe renal nerve ablation. The remote thermal effect is located in the adventitia and perivascular region, with no thermal damage to the endothelium and media, therefore, preventing the development of vessel injury processes. Swine kidney tissue NE concentrations at 30- and 90-day follow-up have demonstrated successful renal denervation as witnessed by a 50% or more decline in tissue NE. Localized tissue thermal modulation/ablation, without damage to the blood vessel wall.

US, MN – SYMPLICITY HTN 2 by Medtronic average office-based BP drops of BP drop, mm Hg 32/12 mm Hg at six months in the SYMPLICITY HTN 2 trial, as reported by heartwire, with 84% of patients having had a >10-mm-Hg drop in systolic blood pressure from baseline. 14 points in 30 days and 27 points after 1 year. Available in Europe. Medtronic is the furthest ahead in its development process, predicting it will get Symplicity on the American market by 2015. catheter in the renal artery near each kidney to deliver radiofrequency energy to ablate the nerves. A single electrode in contrast to St. Jude’s mutli-electrode approach, is already on the road to FDA review with clinical trials approved last summer in the U.S. Symplicity system has been safely used in nearly 5,000 patients since commercialization

US, MN – EnligHTN 1 by St Jude radiofrequency (RF) energy to create lesions (tiny scars) along the renal sympathetic nerves Mean office BP changes at one month in BP drop, mm Hg 28 systolic and -10 diastolic after 1 month (p<0.0001 from baseline), with 78% of patients having systolic BP drops of >10 mm Hg. St. Jude Medical’s (St. Paul, MN) announcement in late 2011 of the first patient to be enrolled in their first-in-man ARSENAL trial ¹⁵ at the University of Adelaide

Ireland, Dublin – OneShot™ by Covidien acquisition of Maya Medical, Saratoga, CA New Irrigated RF Balloon Catheter secure first human use for the device in the third quarter of this year, followed by a CE mark for the drug-resistant hypertension treatment in 2013. Presumably, a filing with the FDA would follow that. the OneShot renal denervation system, was born out of the company’s extensive expertise in radiofrequency (RF) ablation and percutaneous coronary interventions (PCI), drawing upon the benefits and best practice standards of each distinct yet complementary clinical discipline. The result is a unique product platform that could further accelerate the paradigm shift in the management of resistant hypertension. consistent with Maya’s balloon-based approach is the ability to deliver predictable apposition of the RF electrode to the vessel wall for more controlled targeted delivery of the RF energy. By offering a more reliable single-treatment approach coupled with enhanced ease of use and reduced procedure times, Maya Medical believes its OneShot renal denervation system has the potential to significantly expand clinical adoption

http://bmctoday.net/evtoday/2012/02/article.asp?f=renal-artery-denervation-a-brave-new-frontier

US, Natick, MA Boston Scientific lags behind in the race to cash in on hypertension-treating devices, incoming CEO Michael Mahoney said at a Monday conference that it has a plan for its RDN renal denervation system. As MassDevice reports, Mahoney said Boston Sci expects to secure first human use for the device in the third quarter of this year, followed by a CE mark for the drug-resistant hypertension treatment in 2013.

St Jude’s EnligHTN system

Said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division “This launch is important because it represents a significant growth opportunity and exemplifies our commitment to advancing the practice of medicine. We’ve applied the decades of insight we’ve gained from developing successful ablation technologies that treat cardiac arrhythmias to establish an innovative solution for hypertension.” With the unique basket design, each placement of the ablation catheter allows a consistent and predictable pattern of four ablations in 90-second intervals. Compared to single electrode ablations, the multi-electrode EnligHTN system has the potential to improve consistency and procedural reliability, save time as well as result in workflow and cost efficiencies. Additionally, the minimal catheter repositioning may result in a reduction of contrast and fluoroscopic (x-ray) exposure. The technology includes a guiding catheter, ablation catheter and ablation generator. The generator uses a proprietary, temperature-controlled algorithm to deliver effective therapy.

http://investors.sjm.com/phoenix.zhtml?c=73836&p=irol-newsArticle&ID=1695802

http://medgadget.com/2012/05/st-jude-medical-launches-enlightn-renal-denervation-system.html

St Jude’s EnligHTN system – view video

http://www.sjmprofessional.com/Products/Intl/Renal-Ablation-Therapy/enlightn-renal-denervation-system.aspx

Covidien

Unveiled a Novel Renal Denervation System OneShot™ at EuroPCR congress in Paris on 5/16/2012. “Live” Cases with New Irrigated RF Balloon Catheter for Treatment of Medication-resistant Hypertension and poor outcomes of pharmacological agents. The OneShot system is an irrigated, radiofrequency (RF) based balloon catheter used to ablate the renal sympathetic nerves located in the outer wall of the renal arteries. The OneShot technology received CE mark clearance in February 2012.

The OneShot system was featured in “live” cases at the Covidien-sponsored “Tools & Techniques (TNT) Interventions” presentation and panel session for hypertension and renal denervation at the EuroPCR congress. Professor Dirk Scheinert performed two cases at Park Hospital in Leipzig, Germany, that were transmitted live at the Palais des Congrès de Paris. In addition, John Ormiston, MD, Medical Director for Mercy Angiography and President of the Asia-Pacific Society of Interventional Cardiology in New Zealand, presented first-in-human results of cases performed with the OneShot system in New Zealand. The OneShot system and Covidien’s other endovascular solutions was on display at the EuroPCR meeting.

Additional faculty in the TNT session is a distinguished group of speakers including:

Professor Karl-Heinz Kuck, MD, F.A.C.C. – Director, Cardiology Department Allgemeines Krankenhaus St. Georg – Hamburg, Germany

Dr. Stephen R. Ramee, FACC, FSCAI Ochsner Medical Center – New Orleans, Louisiana

Dr. John Ormiston, MBChB, FRACP – Medical Director Mercy Hospital Angiography Unit – Auckland, New Zealand

Professor Marc Sapoval, MD, PhD – Department Head Cardiovascular/Interventional Radiology – Hospital Pompidou University – Paris, France

Dr. Renu Virmani – Medical Director CVPath Institute – Gaithersburg, Maryland

Covidien discloses that it purchased Maya Medical for $60 million in cash on April 20. If Maya Medical meets certain regulatory and sales milestones, it will receive up to an additional $170 million. Covidien notes that Maya Medical’s OneShot system received the CE Mark in February.

MedCity News was the first to report Covidien’s interest in Maya Medical on 5/8/2012.

In a note to investors Monday, analyst Bob Hopkins of Bank of America said that renal denervation “has the potential to be one of the largest new markets in medtech over the next 2-4 years and for [Covidien] this looks like another small deal with big potential.”

http://medcitynews.com/2012/05/covidien-discloses-60m-purchase-of-hypertension-treatment-firm/?edition=medical-devices

Clinical Trial for RAPID is ongoing

Rapid Renal Sympathetic Denervation for Resistant Hypertension (RAPID)

This study is currently recruiting participants.

Verified June 2012 by Maya Medical

First Received on January 25, 2012. Last Updated on June 4, 2012 History of Changes

Sponsor:	Covidien (Maya Medical)
Collaborator:	Meditrial Europe LTD
Information provided by (Responsible Party):	Maya Medical
ClinicalTrials.gov Identifier:	NCT01520506

Purpose

Maya Medical OneShot™ Ablation System use is to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.

Condition	Intervention	Phase
Hypertension, Resistant to Conventional Therapy	Device: Maya Medical OneShot	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy StudyIntervention Model: Single Group AssignmentMasking: Open LabelPrimary Purpose: Treatment
Official Title:	Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the Maya Medical OneShot™ Ablation System

http://www.clinicaltrials.gov/ct2/results?term=Renal+Denervation&pg=2&show_flds=Y

Covidien into direct competition with Medtronic, whose Symplicity renal denervation system is approved in Europe. Currently, the system is being tested in the U.S. St. Jude Medical, Medtronic’s in-state rival, is also developing a therapy and that is expected to have a limited European market launch before the end of the year. But it is not only the larger players that Covidien will have to play against in Europe. A whole host of companies is developing products there, including ReCor Medical.

http://www.canada.com/entertainment/ReCor+Medical+discloses+data+from+clinical+study+PARADISE+ultrasound/6430884/story.html

Medtronic

Medical device giant Medtronic (NYSE: MDT), November 23, 2010 said it has agreed to pay $800 million upfront, plus commercial milestone payments through 2015, to acquire Mountain View, CA-based Ardian. Medtronic had previously built up an 11 percent ownership stake in Ardian, when it invested with its venture backers, which include Morgenthaler Ventures, Advanced Technology Ventures, Split Rock Partners, and Emergent Medical Partners. Ardian’s windfall comes about one week after it presented some eye-opening clinical trial results in The Lancet, and at the American Heart Association’s scientific meeting.

http://www.xconomy.com/san-francisco/2010/11/23/medtronic-buys-ardian-for-800m-upfront-grabs-novel-treatment-for-high-blood-pressure/

Clinical Trial for SYMPLICITY is ongoing.

Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)

This study is currently recruiting participants.

Verified June 2012 by Medtronic Vascular

First Received on August 15, 2011. Last Updated on June 11, 2012 History of Changes

Sponsor:	Medtronic Vascular
Information provided by (Responsible Party):	Medtronic Vascular
ClinicalTrials.gov Identifier:	NCT01418261

Purpose

The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter – a percutaneous system that delivers radiofrequency (RF)energy through the luminal surface of the renal artery.

Condition	Intervention	Phase
Uncontrolled Hypertension	Device: Renal denervation (Symplicity Catheter System)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: RandomizedEndpoint Classification: Safety/Efficacy StudyIntervention Model: Parallel AssignmentMasking: Single Blind (Subject)Primary Purpose: Treatment

http://clinicaltrials.gov/ct2/show/NCT01418261

The Symplicity™ Renal Denervation System has two main components:

The elements are designed to work together as an integrated system to ensure consistent performance:

Symplicity™ Catheter – Low profile, endovascular energy delivery catheter

Symplicity™ Generator – Automated, portable RF generator

The Symplicity Renal Denervation System uses controlled, low-power radiofrequency (RF) energy to deactivate the renal nerves, thereby selectively reducing both the pathologic central sympathetic drive to the kidney and the renal contribution to central sympathetic hyperactivity. The outcome, we hope, will be a significant and sustained reduction in both blood pressure and the level of systemically damaging neurohormones. Since the endovascular procedure does not involve an implant, patients recover quickly and can soon return to their daily living. The device may usher in a new era in the treatment of hypertension, hopefully allowing a one-time procedure to offer patients a long-lasting benefit.

Medtronic Procedure – view video

http://www.ardian.com/ous/medical-professionals/procedure.shtml

Conclusions

The entire industry subsegment is awaiting the results of SYMPLICITY HTN-3. Forecasts of market share by supplier will be predicated on this Clinical Trial completion.

Shutting down overactive nerves around the kidneys as a strategy for fighting resistant hypertension is “one of the most exciting growth markets in medical devices,” Sean Salmon, vice president and general manager of Medtronic’s coronary and peripheral business, said in a statement.

I had a piece in these pages last week about what kind of difference the Ardian treatment was making. The most recent Ardian study showed the new treatment, in combination with standard drugs, was able to bring average blood pressure scores down from 178 over 97 to 146 over 85 after six months of follow-up, while those who just got standard treatments were essentially unchanged. The results were “a big achievement,” according to Murray Esler, the study’s principal investigator.

http://www.xconomy.com/san-francisco/2010/11/23/medtronic-buys-ardian-for-800m-upfront-grabs-novel-treatment-for-high-blood-pressure/

Resources

REFERENCES for Dr. Scherlag’s 1999 Patent and pioneering work on Intravascular Stimulation/Ablation of Autonomics

1. Schauerte P, Scherlag BJ, Scherlag MA, Goli S, Jackman WM, Lazzara R. Transvenous parasympathetic cardiac nerve stimulation: an approach for stable sinus rate control. J Electrophysiol. 1999 Nov;10(11):1517-24.

2. Schauerte P, Scherlag BJ, Scherlag MA, Goli S, Jackman WM, Lazzara R. Ventricular rate control during atrial fibrillation by cardiac parasympathetic nerve stimulation: a transvenous approach. J Am Coll Cardiol. 1999 Dec;34(7):2043-50.

3. Schauerte P, Scherlag BJ, Pitha J, Scherlag MA, Reynolds D, Lazzara R, Jackman WM. Catheter ablation of cardiac autonomic nerves for prevention of vagal atrial fibrillation. Circulation. 2000 Nov 28;102(22):2774-80.

4. Scherlag MA, Scherlag BJ, Yamanashi W, Schauerte P, Goli S, Jackman WM, Reynolds D, Lazzara R. Endovascular neural stimulation via a novel basket electrode catheter: comparison of electrode configurations. J Interv Card Electrophysiol. 2000 Apr;4(1):219-24.

5. Scherlag BJ, Yamanashi WS, Schauerte P, Scherlag M, Sun YX, Hou Y, Jackman WM, Lazzara R. Endovascular stimulation within the left pulmonary artery to induce slowing of heart rate and paroxysmal atrial fibrillation. Cardiovasc Res. 2002 May; 54(2):470-5.

6. Hasdemir C, Scherlag BJ, Yamanashi WS, Lazzara R, Jackman WM. Endovascular stimulation of autonomic neural elements in the superior vena cava using a flexible loop catheter. Jpn Heart J. 2003 May;44(3):417-27.

7. Webster W Jr, Scherlag BJ, Scherlag MA, Schauerte P. Method and apparatus for transvascular treatment of tachycardia and fibrillation. US Patent 6,292,695. Filed June 17, 1999.

8. Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009;373(9671):1275-1281.

9. Symplicity HTN-2 Investigators. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010;376:1903-1909.

10. Frank Himmel MD, Joachim Weil MD, Michael Reppel MD, Kai Mortensen MD, Klaas Franzen, Leidinger Ansgar MD, Heribert Schunkert MD, Frank Bode MD. Improved Heart Rate Dynamics in Patients Undergoing Percutaneous Renal Denervation. Letter to the Editor. JCH. 31 MAY 2012.1751-7176.

Sympathetic Hyperactivity & Hypertension

For more information on hypertension, please visit the medical professional hypertension portal at TheHeart.org .

Siddiqi L, Joles JA, Grassi G, Blankestijn PJ. Is kidney ischemia the central mechanism in parallel activation of the renin and sympathetic system? J Hypertens. 2009 Jul;27(7):1341-9.

Augustyniak RA, Tuncel M, Zhang W, Toto RD, Victor RG. Sympathetic overactivity as a cause of hypertension in chronic renal failure. J Hypertens. 2002;20(1):3-9.

DiBona GF. Sympathetic nervous system and the kidney in hypertension. Curr Opin Nephrol Hypertens. 2002;11(2):197-200.

Mancia G, Grassi G, Giannattasio C, Seravalle G. Sympathetic activation in the pathogenesis of hypertension and progression of organ damage. Hypertension. 1999;34(4 Pt 2):724-728.

References in Scientific Journals about Renal Denervation Treatment

Symplicity HTN-2 Investigators. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010;376:1903-1909.

Symplicity HTN-1 Investigators. Catheter-Based Renal Sympathetic Denervation for Resistant Hypertension – Durability of Blood Pressure Reduction Out to 24 Months. Hypertension. Volume 57, Number 5, May 2011.

Rippy, M. et al. Catheter-Based Renal Sympathetic Denervation: Chronic Preclinical Evidence for Renal Artery Safety. Clin Res Cardiol. 2011 Dec; 100(12): Pages 1095-1101.

Mahfoud, F. et al. Effect of Renal Sympathetic Denervation on Glucose Metabolism in Patients With Resistant Hypertension. Circulation. Volume 123, No. 18, May 10, 2011. Pages 1940-1946.

Witkowski A., et al. Effects of Renal Sympathetic Denervation on Blood Pressure, Sleep Apnea Course, and Glycemic Control in Patients with Resistant Hypertension and Sleep Apnea. Hypertension. Volume 58, Number 4, October 2011. Pages 559-565.

Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009;373(9671):1275-1281.

Schlaich MP, Sobotka PA, Krum H, Lambert E, Esler MD. Renal Sympathetic-Nerve Ablation for Uncontrolled Hypertension. N Engl J Med. 2009;361(9):932-934.

Schlaich MP, Sobotka PA, Krum H, Whitbourn R, Walton A, Esler MD. Renal Denervation as a Therapeutic Approach for Hypertension. Novel Implications for an Old Concept. Hypertension. 2009;54(6):1195-1201.

Esler M. The 2009 Carl Ludwig Lecture: pathophysiology of the human sympathetic nervous system in cardiovascular diseases: the transition from mechanisms to medical management. J Appl Physiol. 2010;108(2):227-237.

Dibona GF, Esler MD. Translational Medicine: the antihypertensive effect of renal denervation. Am J Physiol Regul Integr Comp Physiol. 2010;298(2):R245-253.

Katholi RE, Rocha-Singh KJ. The role of renal sympathetic nerves in hypertension: has percutaneous renal denervation refocused attention on their clinical significance? Prog Cardiovasc Dis. 2009;52(3):243-248.

Doumas M, Faselis C, Papademetriou V. Renal Sympathetic Denervation and Systemic Hypertension. Am J Cardiol. 2010;105(4):570-576.

Schlaich MP, Krum H, Sobotka PA. Renal sympathetic nerve ablation: the new frontier in the treatment of hypertension. Curr Hypertens Rep. 2010;12(1):39-46.

Katholi RE, Rocha-Singh KJ, Goswami NJ, Sobotka PA. Renal nerves in the maintenance of hypertension: A potential therapeutic target. Curr Hypertens Rep. 2010;12:196-204.

Esler MD, Lambert EA, Schlaich M, Navar LG. The Dominant Contributor to Systemic Hypertension: Chronic Activation of the Sympathetic Nervous System vs Activation of the Intrarenal Renin-Angiotensin System. J Appl Physiol. 2010.

Fisher JP, Fadel PJ. Therapeutic strategies for targeting excessive central sympathetic activation in human hypertension. Exp Physiol. 2010;95(5):572-580.

Malpas SC. Sympathetic nervous system overactivity and its role in the development of cardiovascular disease. Physiol Rev. 2010;90:513-557.

Lambert GW, Straznicky NE, Lambert EA, Dixon JB, Schlaich MP. Sympathetic nervous activation in obesity and the metabolic syndrome–causes, consequences and therapeutic implications. Pharmacol Ther. 2010;126:159-172.

Masuo K, Lambert GW, Esler MD, Rakugi H, Ogihara T, Schlaich MP. The role of sympathetic nervous activity in renal injury and end-stage renal disease. Hypertens Res. 2010;33:521-528.

Schlaich MP, Socratous F, Hennebry S, Eikelis N, Lambert EA, Straznicky N, Esler MD, Lambert GW. Sympathetic activation in chronic renal failure. J Am Soc Nephrol. 2009;20(5):933-939.

Bock JS, Gottlieb SS. Cardiorenal syndrome: New perspectives. Circulation. 2010;121:2592-2600.

Goldsmith SR, Sobotka PA, Bart BA. The sympathorenal axis in hypertension and heart failure. Journal of Cardiac Failure. 2010;16(5):369-373.

Grassi G. Assessment of sympathetic cardiovascular drive in human hypertension: achievements and perspectives. Hypertension. 2009;54(4):690-697.

Ritz E. New approaches to pathogenesis and management of hypertension. Clin J Am Soc Nephrol. 2009;4(12):1886-1891.

Ritz E, Rump LC. Control of sympathetic activity–new insights; new therapeutic targets? Nephrol Dial Transplant. 2010;25(4):1048-1050.

Joyner MJ, Charkoudian N, Wallin BG. Sympathetic nervous system and blood pressure in humans: Individualized patterns of regulation and their implications. Hypertension. 2010;56:10-16.

Mann JF. Whats new in hypertension 2009? Nephrol Dial Transplant. 2010;25(1):37-41.

Bravo EL, Rafey MA, Nally JV, Jr. Renal denervation for resistant hypertension. Am J Kidney Dis. 2009;54(5):795-797.

King A. Hypertension: RF ablation of renal nerves. Nature Reviews Nephrology. 2009;5:364.

Doumas M, Douma S. Interventional management of resistant hypertension. Lancet. 2009;373(9671):1228-1230.

Paulis L. Novel therapeutic targets for hypertension. Nat Rev Cardiol. 2010.

OBrien E. Renal sympathetic denervation for resistant hypertension. Lancet. 2009;373(9681):2109; author reply 2109-2110.

Titze S, Uder M, Schmieder R. Renal nerve ablation: innovative therapy for treatment of resistant hypertension. MMW Fortschr Med. 2009;151(42):52-53.

Katona PG. Biomedical engineering in heart-brain medicine: A review. Cleve Clin J Med. 2010;77 Suppl 3:S46-50.

Abstracts about Renal Denervation Treatment

Schlaich M, Krum H, Walton T, Whitbourn R, Sobotka P, Esler M. Two-year durability of blood pressure reduction with catheter-based renal sympathetic denervation. Journal of Hypertension. 2010;28:e446.

Esler M, Schlaich M, Sobotka P, Whitbourn R, Sadowski J, Bartus K, et al. Catheter-Based Renal Denervation Reduces Total Body and Renal Noradrenaline Spillover and Blood Pressure in Resistant Hypertension. Journal of Hypertension. 2009;27(suppl 4):s167.

Schlaich MP, Krum H, Whitbourn R, Walton T, Lambert GW, Sobotka PA, et al. Effects of Renal Sympathetic Denervation on Noradrenaline Spillover and Systemic Blood Pressure in Patients with Resistant Hypertension. Journal of Hypertension. 2009;27(suppl 4):s154.

Schlaich M, Krum H, Walton T, Lambert E, Lambert G, Sobotka P, et al. A Novel Catheter Based Approach to Denervate the Human Kidney Reduces Blood Pressure and Muscle Sympathetic Nerve Activity in a Patient with End Stage Renal Disease and Hypertension. Journal of Hypertension. 2009;27(suppl 4):s437.

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The Genetics of Pain: An Integrated Approach

Posted in Bone Disease and Musculoskeletal Disease, CANCER BIOLOGY & Innovations in Cancer Therapy, Cardiovascular Pharmacogenomics, Cell Biology, Signaling & Cell Circuits, Chemical Biology and its relations to Metabolic Disease, Chemical Genetics, Computational Biology/Systems and Bioinformatics, Genome Biology, Personalized and Precision Medicine & Genomic Research, Pharmacotherapy of Cardiovascular Disease, Uncategorized, tagged Chronic pain, Clifford J. Woolf, health, intensity pattern, medicine, myocardial infarction, Pain, Pain management, peripheral nerve fibers, Quality of life on June 12, 2012| 5 Comments »

Curated by: Dr. V. S. Karra, Ph.D.

Pain is a major symptom in many medical conditions, and can significantly interfere with a person’s quality of life and general functioning.[1]. It is often caused by intense or damaging stimuli, such as stubbing a toe, burning a finger, putting alcohol on a cut, and bumping the “funny bone.”

Pain is an absolutely unpleasant one. Knowing the time of onset, location, intensity, pattern of occurrence (continuous, intermittent, etc.), exacerbating and relieving factors, and quality (burning, sharp, etc.) of the pain will help the examining physician to accurately diagnose the problem. For example, chest pain described as extreme heaviness may indicate myocardial infarction, while chest pain described as tearing may indicate aortic dissection.

Acute pain is usually managed with medications such as analgesics and anesthetics. Management of chronic pain, however, is much more difficult and may require an interdisciplinary approach for treating or easing the suffering and improving the quality of life. Psychological factors such as social support, hypnotic suggestion, excitement, or distraction can significantly modulate pain’s intensity or unpleasantness.

The International Association for the Study of Pain (IASP) states that “Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage”.[2].

Following is the IASP’s classification of pain:

(1) region of the body involved (e.g., abdomen, lower limbs),

(2) system whose dysfunction may be causing the pain (e.g., nervous, gastrointestinal),

(3) duration and pattern of occurrence,

(4) intensity and time since onset, and

(5) etiology

This system has been criticized by Clifford J. Woolf and others as inadequate for guiding research and treatment.

According to Woolf, there are three classes of pain :

Nociceptive pain: is caused by stimulation of peripheral nerve fibers and the stimulants could be Thermal, Mechanical and/ or Chemical. For example “heat or cold” (thermal), “crushing, tearing, etc.” (mechanical) and “iodine in a cut, chili powder in the eyes” (chemical).

Inflammatory pain: is associated with tissue damage and the infiltration of immune cells, and

Pathological pain: is a disease state caused by damage to the nervous system (neuropathic pain) or by its abnormal function (dysfunctional pain, like in fibromyalgia, irritable bowel syndrome, tension type headache, etc.).[3]

Pain will have a very detrimental effect on the quality of life. Experimental subjects challenged by acute pain and patients in chronic pain experience impairments in attention control, working memory, mental flexibility, problem solving, and information processing speed.[4]. Acute and chronic pain are also associated with increased depression, anxiety, fear, and anger.[5].

Patients who often have a background level of pain controlled by medications and whos pain periodically “breaks through” the medication is called breathrough pain and it is common in cancer patients . The characteristics of breakthrough cancer pain vary from person to person and according to the cause.

Harold Merskey said: “If I have matters right, the consequences of pain will include direct physical distress, unemployment, financial difficulties, marital disharmony, and difficulties in concentration and attention…”

Pain perception (point at which the stimulus begins to hurt) and tolerance thresholds (point at which the individual can’t tolerate the pain any more and when the subject acts to stop the pain) are not the same. The perception of pain is influenced by a multitude of variables including gender, age, mood, ethnicity and genetic factors [6],

Thus it is important to:

understand mechanisms of susceptibility to (chronic) pain,
Explore the genetics, emphasizing the conservation of pain-related genes, their functions and their advantages if any
Understand the role of gene polymorphisms in normal and pathological modulation of pain in models, humans, and as future drug targets
Explore the latest findings from human genome-wide investigation of genomic variability and gene expression on pain
Understand genetic and genomic techniques to study genetic contribution to (human) pain.
Study the progress of cutting-edge clinical trials and translate research findings to clinical practice
develop preventative approaches and novel treatment strategies

Advances in molecular, statistical and behavioral methodologies have suddenly allowed genetic investigations of complex biological phenomena, including pain. Genetic studies of pain are already showing their power to identify new molecular targets for drug development and create new animal models of pain pathology, says Jeffrey S. Mogil, PhD who is currently the E.P. Taylor Professor of Pain Studies and the Canada Research Chair in the Genetics of Pain and wrote a book on “The Genetics of Pain“.

Pain genetics can explain why we’re not all alike with respect to pain – why some people hurt more, and receive less benefit from existing analgesics. The knowledge gained holds the promise of allowing truly individualized pain therapy, says Mogil.

Algorithms for accessing and integrating available public data to examine disease-relevant mechanisms are of growing interest as publically available data sets grow at an ever-increasing rate. A meta-analysis of publicly available microarray data from rodents exposed to neuropathic or inflammatory pain was able to efficiently prioritize pain-related genes [7].

A similar approach using human gene expression data could be highly beneficial in generating data-driven hypotheses for pain genetics.

Most recent article, published on June 7, 2012, in open access journal PLoS Computational Biology, on “Integrative Approach to Pain Genetics Identifies Pain Sensitivity Loci across Diseases” presented a novel integrative approach that combines publicly available molecular data and automatically extracted knowledge regarding pain contained in the literature to assist the discovery of novel pain genes. This study was approved by the Institutional Review Boards of Stanford University and SRI International.

In this meta-analysis, they took advantage of the vast amount of existing disease-related clinical literature and gene expression microarray data stored in large international repositories and

Ranked thousands of diseases according to the Figure shown below.

Obtained gene expression profiles of 121 of these human diseases from public sources.
Selected ‘genes with expression variation significantly correlated with DSPI across diseases’ as candidate pain genes.
Genotyped selected candidate pain genes in an independent human cohort, and finally
Evaluated for significant association between variants and measures of pain sensitivity.

In this study, the genes were chosen based on their high correlation with the DSPI and plausible biology as assessed by the available literature and human expression profile across tissue using The Scripps Research Institute BioGPS database [8].

The selected genes were:

ABLIM3 (actin binding LIM protein family, member 3),
PDE2A (phosphodiesterase 2A, cGMP-stimulated),
CREB1 (cAMP responsive element binding protein 1),
NAALAD2 (N-acetylated alpha-linked acidic dipeptidase 2), and
NCALD (neurocalcin delta).

These genes were selected from the candidate list and were prospectively tested for variants that may be associated with differential pain sensitivity in an independent human cohort.

ABLIM3 was selected as the top candidate as it showed the highest correlation with the DSPI. ABLIM3 is a newly characterized protein-coding gene. ABLIM3 is expressed in various tissues, most prominently in muscle and neuronal tissue [9], [10].

Polymorphisms in ABLIM3 (rs4512126) and NCALD (rs12548828, rs7826700, and rs1075791) showed significant association with the cold pressor pain threshold

“The strongest signal was with rs4512126 (5q32, ABLIM3, P = 1.3×10⁻¹⁰⁾for the sensitivity to cold pressor pain in males, but not in females – a sex-specific association.”

Significant associations were also observed with rs12548828, rs7826700 and rs1075791 on 8q22.2 within NCALD (P = 1.7×10−4, 1.8×10−4, and 2.2×10−4 respectively).

Authors said that, “This data-derived list of pain gene candidates enables additional focused and efficient biological studies validating additional candidates.”

Authors have demonstrated the utility of a novel paradigm that integrates publicly available disease-specific gene expression data with clinical data curated from MEDLINE to facilitate the discovery of pain-relevant genes. This approach was validated through a targeted genetic association study in an independent human cohort, where variants of selected pain gene candidates were evaluated for associations with experimental pain sensitivity measures in humans.

Authors hope that “the outlined approach can complement existing research efforts by assisting the formulation of data-driven hypotheses, and may serve as a template to discover genetic components of other clinically important phenotypes.“

Centers for Medicare and Medicaid (CMS) Targets Hospital Readmissions – A Disconnect Among the Hospitals or Poor Education?

Posted in Health Economics and Outcomes Research, Population Health Management, Genetics & Pharmaceutical, Uncategorized, tagged Accountable Care, CMS, Health Care Delivery, Latest News, Population Health Management on June 12, 2012| 3 Comments »

Reporter: Alan F. Kaul, PharmD. MS. MBA, FCCP

As a part of the Accountable Care Act (ACA) added to the Social Security Act, CMS under the Hospital Readmissions Reduction Program (HRRP) is required to reduce payments to Inpatient Prospective Payment System (IPPS) hospitals reporting excess readmissions commencing with discharges on October 1, 2012.

In the FY2012 IPPS final rule, readmission measures for Acute Myocardial Infarction (AMI), Heart Failure (HF), and Pneumonia (PN) and the calculated excess readmission ratio will be used, in part, to calculate the readmission payment adjustment under the HRRP. CMS using risk adjustment endorsed by the National Quality Forum (NQF) and adjustments for clinically relevant factors such as patient comorbidity, frailty, and demographics will use a national dataset to compare to each hospital’s set of patients. CMS will look-back at three years worth of each hospital’s discharges and a minimum of 25 cases to calculate a hospital’s excess readmission rate for each condition. Beginning FY 2013, each excess readmission ratio will look at discharges occurring from July 1, 2008 through June 30, 2011.

In its FY2013 proposed rules making cycle, CMS proposed to continue the process and which hospitals will be subject to the HRRP, the methodologies used in its calculations, and a process for hospitals to review the information and submit proposed corrections before the information is publically released.

While CMS moves forward with its HRRP, hospitals readiness for population-base accountable care is questionable. A national survey of all hospitals was undertaken in 2011 to assess the current state of hospital readiness in the development of Accountable Care Organizations (ACOs). There were 1,672 responses to the survey or a 34% response rate. Several major themes were identified such as:

1. Only a small percentage of hospitals (3%) participate in ACOs and only 10% were preparing to do so.
2. Hospitals expect their revenue sources fro risk-based financial reimbursement to double from 9% to 18% over the next two years.
3. Most hospitals were engaged in numerous care co-ordination methods, though there was variation in specific practices.
4. There are several perceived barriers between hospitals preparing to participate an ACO and hospitals participating in ACOs. Of note, the greatest challenges of those hospitals participating in ACOS were perceived to be reducing clinical variation and reducing costs. Those planning participation, the greatest challenge was perceived to be increasing the size of the covered patient population.
5. ACO hospitals are significantly more involved in population health management services including coordination across the continuum of care.
6. There are significant gaps in care coordination functionalities. For example, there is a low-use of risk stratification and other care coordination activities. As an example, only 38% of hospitals participating in ACOs, 33% planning their participating, and 24% of hospitals not exploring an ACO model assign case managers to patients at risk for hospital readmission for out-patient follow-up. Less than 25% of hospitals in each group have nurse case managers who work with patients with chronic diseases. Similarly, 23%, 21%, and 11% respectively of those hospitals participating, planning participation, or with no plans to participate in an ACO have a post-hospital discharge continuity of care program with scaled intensiveness. Approximately one-third of hospitals participating in or preparing to participate in an ACO have no chronic-care registry. About 20% have a registry for one condition and 40% for two conditions.
7. ACOs are striving to improve the quality of their services by using valid performance measures and making results available to the public and participating providers.

Sources:

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Readmissions-Reduction-Program.html

Hospital Readiness for Population-based Accountable Care. Health Research and Educational Trust, Chicago:April 2012. Accessed at http://www.hope.org

Accessible at: http://www.hpoe.org/accointable-care

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Archive for June, 2012

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Global Supplier Strategy for Market Penetration &amp; Partnership Options (Niche Suppliers vs. National Leaders) in the Massachusetts Cardiology &amp; Vascular Surgery Tools and Devices Market for Cardiac Operating Rooms and Angioplasty Suites

Curator: Aviva Lev-Ari, PhD, RN

Medical Devices Market in Massachusetts: Product Concentration Ratios (1 to 10) by Product and Partnership Target Advantage – Niche Suppliers vs. National Leader in the Cardiology & Vascular Surgery Tools and Devices in use in Cardiac Operating Rooms and in Angioplasty Suites

Product Advantage for Partnership with Niche Suppliers in MA

Product Advantage for Partnership with National Leader in MA

Product Advantage for Partnership with Niche Suppliers and National Leader in MA

Penetration Strategy for a Global Supplier Targeting the US Market in Massachusetts

Customized predictions of penetration cost and estimation of potential revenues based on the industry segment concentration ratios in the Table above per Partnership Option are part of an Actionable Strategic Market Entry Plan in Massachusetts.

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Competition in the Ecosystem of Medical Devices in Cardiac and Vascular Repair: Heart Valves, Stents, Catheterization Tools and Kits for Open Heart and Minimally Invasive Surgery (MIS)

This report covers the following product categories

Heart Valve Frames:

Stents:

Surgical tools:

The ecosystem of Cardiac and Vascular Surgery for Repair or Replacement by Implantation of a new blood vessel or medical device covers the following procedure-related devices and tools now in use:

Product Category Total US and Total Global Suppliers, Suppliers in MA by Product, Segment Industry Concentration in the US and in MA

Industry Segment Concentration Ratio: Impact on Market Penetration Cost and Potential Revenue and Market Share per Product Line

Penetration Strategy for a Global Supplier Targeting the US Market and the Massachusetts Market

Customized predictions of penetration cost and estimation of potential revenues based on the industry segment concentration ratios in the Table above are part of an Actionable Strategic Market Entry Plan into the US market.

Contact Us

National Medical Device Suppliers within the Cardiac and Vascular Repair Market by Product Category

Cardiology vascular surgery – The OR equipment

Arterial catheterization kit suppliers

Embolectomy catheters suppliers

Arrow Internacional De Mexico, S.A. De C.V. +52-(610)-378-0131

Occlusion catheter suppliers

Billary stents

Carotid shunts suppliers

External and internal carotid shunts suppliers

Micro vascular clips suppliers

Stainless steel tunneler vascular graft suppliers

Vascular stent suppliers

Cardiopulmonary bypass vascular catheter suppliers

Catheter tip occluder suppliers

Synthetic/biological composite vascular graft suppliers

Valvulotome suppliers

Guided wires

Guided Wires MA based

Aortic Valve

Mitral Valve

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Cancer and Bone: low magnitude vibrations help mitigate bone loss

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The Centers for Medicare &amp; Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED)

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Edwards Lifesciences Reports Strong 2012 Fourth Quarter Results

History of Edwards Lifesciences

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Treatment of Refractory Hypertension via Percutaneous Renal Denervation

Procedure Benefits

Benefits and New Indications for Usage of Intravascular Stimulation/Ablation of Autonomics

Procedure Risks

Medical Debate on the Procedure – The candidates are hypertensive patients receiving blood-pressure-lowering medication that are truly “resistant.”

Treating the Truly Medication Treatment “Resistant”

The Global Supplier Ecosystem for Renal Denervation Systems

St Jude’s EnligHTN system

Covidien

Medtronic

Conclusions

Resources

Sympathetic Hyperactivity & Hypertension

Abstracts about Renal Denervation Treatment

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Global Supplier Strategy for Market Penetration & Partnership Options (Niche Suppliers vs. National Leaders) in the Massachusetts Cardiology & Vascular Surgery Tools and Devices Market for Cardiac Operating Rooms and Angioplasty Suites

The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED)