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Posts Tagged ‘Implantable Synchronized Cardiac Assist Device’

Expected New Trends in Cardiology and Cardiovascular Medical Devices

Posted in Bio Instrumentation in Experimental Life Sciences Research, Biomarkers & Medical Diagnostics, BioSimilars, Cardiac & Vascular Repair Tools Subsegment, Cell Biology, Signaling & Cell Circuits, Chemical Biology and its relations to Metabolic Disease, Disease Biology, Small Molecules in Development of Therapeutic Drugs, Ecosystems & Industrial Concentration in the Medical Device Sector, FDA Regulatory Affairs, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, HTN, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Origins of Cardiovascular Disease, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, Pharmacotherapy of Cardiovascular Disease, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, tagged , , , , , , , on August 17, 2012| 8 Comments »

Expected New Trends in Cardiology and Cardiovascular Medical Devices

Reported: Aviva Lev-Ari, PhD, RN

 

UPDATED on 11/22/2018 – Published Activity on http://pharmaceuticalintelligence.com

  • World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017, BOSTON, MA

(a) Real Time Highlights and Tweets: Day 1,2,3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017, BOSTON, MA

(b) e-Proceedings for Day 1,2,3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017, BOSTON, MA

(c)  Tweets by @pharma_BI and @AVIVA1950 at World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017, BOSTON, MA

 

UPDATED on 11/22/2018 – External Sources

  • Latest Medical Devices, Equipment, & Drug Information in Cardiology

Search the latest Cardiology developments in medical devices, equipment and approved drugs. Find new FDA approved procedures, drugs and devices in the MDLinx Product Center.

https://www.mdlinx.com/cardiology/product-center/

  • 5 New Implantable Cardiovascular Technologies to Watch

Recent device technology advances may offer new therapies for atrial fibrillation and heart failure

https://www.dicardiology.com/article/5-new-implantable-cardiovascular-technologies-watch

  • Advances and Trends in Vascular Closure Devices

Faster hemostasis saves nursing time, speeds patient ambulation

https://www.dicardiology.com/article/advances-and-trends-vascular-closure-devices

  • Drivers and Trends in Cardiovascular Device Development: Insights from Key Opinion Leaders

Medical Device Clinical Trials, Medical Device Design, Medical Device Manufacturing & Supply Chain, Medical Device Safety and Regulation

https://xtalks.com/webinars/cardiovascular-device-development-insights-from-key-opinion-leaders/

Cardiology Industry 2018

View Trends, Analysis and Statistics.

Reportlinker.com offers immediate download access to top market reports on the Cardiology Industry.

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US Cardiology Industry 2018-2022

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SOURCE

https://www.reportlinker.com/market-report/Health-Services/115531/Cardiology?utm_source=bingads_usa&utm_medium=cpc&utm_campaign=Healthcare&utm_adgroup=Cardiology_Trends&msclkid=8801b5a8be3910db0eaaee5e55981f3e&utm_term=%2Bcardiology%20%2Btrends&utm_content=Cardiology%20Trends

 

2012

Dr. Joseph Loscalzo of BWH, the moderator of  the  Cardiology Panel — NEJM Dialogue in Medicine, June 22, 2012 has asked the Panel members: What are the new innovations to be foreseen by each member of the Panel which included Panelists:

Emelia Benjamin, BMC

Eugene Braunwald, BWH,

Desmond Jordan, Columbia University Medical Center

Thomas Luscher, Professor and Chairman of Cardiology at the University Hospital Zurich and Director of CardioVascular Research at the Institute of Physiology of the University Zurich, Switzerland.

Craig Smith, Columbia University Medical Center

Dr. Craig Smith of Columbia University Medical Center bet the future of cardiovascular medical devices on the Implantable Synchronized Cardiac Assist Device which has three version, Left ventricle, Right Ventricle or both

Dr. Eugene Braunwald, Founding Chairman, TIMI Study Group (TIMI stands for ‘Thrombolysis In Myocardial Infarction’ and is the name of an Academic Research Organization (ARO) that, since it was founded by Dr. Eugene Braunwald in 1984, has conducted numerous practice-changing clinical trials in patients with cardiovascular disease or risk factors for cardiovascular disease, he has expressed anticipation of the next big and much needed to be available — the Multiple Pill, one drug that is a combination drugs of ASA, TZD, BB, ACE, Statin.

On this Scientific Web Site — Frontiers in Cardiology is one of the Research Categories on Cardiovascular disease, research directed by Dr. Aviva Lev-Ari, noted to be of great relevance to the innovations foreseen by Dr. Craig Smith and by Dr. Brounwald, as expressed by them on June 22, 2012 in Boston, MA

To read on Implantable Artificial Heart — go to 

Lev-Ari, A. (2012G).  Heart Remodeling by Design: Implantable Synchronized Cardiac Assist Device: Abiomed’s Symphony

http://pharmaceuticalintelligence.com/2012/07/23/heart-remodeling-by-design-implantable-synchronized-cardiac-assist-device-abiomeds-symphony/

To read on the only currently available Multiple Pill — go to 

Lev-Ari, A. (2012b). Triple Antihypertensive Combination Therapy Significantly Lowers Blood Pressure in Hard-to-Treat Patients with Hypertension and Diabetes

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

To watch the video of the Cardiology Panel — go to 

http://nejm200.nejm.org/news-and-events/dialogues-in-medicine/?panel=4

To review our post on the Cardiology Panel — go to 

http://pharmaceuticalintelligence.com/2012/08/16/cardiology-panel-nejm-dialogue-in-medicine-june-22-2012/

To review TIMI research results — go to 

http://www.timi.org/ 

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Heart Remodeling by Design – Implantable Synchronized Cardiac Assist Device: Abiomed’s Symphony

Posted in Bio Instrumentation in Experimental Life Sciences Research, Cardiac & Vascular Repair Tools Subsegment, Ecosystems & Industrial Concentration in the Medical Device Sector, FDA Regulatory Affairs, Frontiers in Cardiology and Cardiovascular Disorders, Massachusetts Niche Suppliers and National Leaders, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Origins of Cardiovascular Disease, Pharmaceutical Industry Competitive Intelligence, Pharmacotherapy of Cardiovascular Disease, tagged , , , , on July 23, 2012| 18 Comments »

Heart Remodeling by Design – Implantable Synchronized Cardiac Assist Device: Abiomed’s Symphony

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED 3/24/2013

Abiomed Facing Reclassification of Heart Pump Medical Device

MARCH 18, 2013 / MEDICAL DEVICE BLOG

Reclassification can often be a stressful and expensive process for medical device manufacturers. The recent case of Abiomed, and reclassification of its Impella 2.5 cardiac assist pump, is an example of the consequences of regulatory shift after a product has already been launched on the market.

The Impella 2.5 example is one that has been borne out of the FDA’s initial willingness to make an exception for nonroller cardiovascular blood pumps. Although technically a Class III device, a regulatory exemption created an opportunity for this type of product to avoid the rigors of the pre-market approval process and instead be marketed via 510(k). The basis of the exemption had to do with Abiomed assuring the agency that its pump was similar to other nonroller-type pumps.

Unfortunately for the company, a recent FDA advisory panel (the Circulatory System Devices Panel) reviewed the exemption (in place since 2008) and recommended that the Impella 2.5 lose its Class III 510(k) status. This decision was made after a careful examination of the changing standards for medical device approval over the course of the last five years.

What does this mean for Abiomed? The reclassification will require that the company provide the FDA with specific information proving the safety and efficacy of the Impella 2.5 device. Abiomed is not optimistic about the potential to demonstrate the benefits of its product to the satisfaction of the agency, especially after a previous study did not offer a compelling argument in favor of the pump. The company has 18 months to complete the work required to gather the needed data to support a PMA. Sales of the pump can continue until the PMA is either accepted or rejected.

 SOURCE:

http://www.aptivsolutions.com/blog/medical-device/2013/03/abiomed-facing-reclassification-of-heart-pump-medical-device/?goback=%2Egde_675087_member_223865458

 

Abiomed shares lower as FDA panel votes to retain Class III status for Impella

December 7, 2012 11:30 am by 

Abiomed, Inc. (Nasdaq: ABMD) last night announced that the U.S. FDA Circulatory System Devices Panel voted to retain Class III status for the temporary ventricular support devices within the non-roller type cardiopulmonary bypass blood pumps category, which includes Impella®. The 515i Reclassification Panel’s confirmation of this category of device as Class III devices is consistent with both the current Class III classification for these device types and as recommended in the FDA’s briefing documents, released on December 3, 2012.

“We would like to thank the 515i Panel and FDA for their time and consideration, as well as Dr. Jeffrey Popma of Beth Israel Deaconess Medical Center and Dr. William O’Neill of Henry Ford Hospital, who highlighted the compelling body of clinical evidence supporting Impella, including the PROTECT II data set,” said Michael R. Minogue, President, Chairman and Chief Executive Officer, Abiomed. “We look forward to collaborating with the FDA on next steps and agree with the 515i Panel’s feedback that our existing data, combined with our U.S. registry, position us to work with the FDA to submit a PMA application. We welcome the opportunity for a PMA to strengthen our existing marketing clearances and expand the indications for Impella patients.”

The FDA’s 515i program is designed to review all previously 510(k) cleared Class III devices and determine the appropriate controls to ensure safety and effectiveness for the intended use of these product categories. The classification of Impella as a Class III device requires Pre-Market Approval (PMA) controls (versus prior 510(k) Class III special controls) to ensure safety and effectiveness in the intended use. As per the 515i Reclassification Process and confirmed by the FDA Panel, products will remain on the market for a sufficient period to allow for manufacturers to submit and the FDA to review Pre-Market Approval applications.

As per the statues of the 515i program, there is no change to the current 510(k) clearance for Impella throughout the remaining steps of the reclassification process for Non-Roller Type Cardiopulmonary Bypass Pumps. Following yesterday’s Panel recommendation, the next steps in the 515i process include FDA issuance of a Proposed Final Order, followed by a period of public comment, FDA issuance of a Final Order, and then submission of Pre-Market Approval applications by manufacturers with devices in the category. Throughout this series of reclassification steps, Abiomed will continue to market the Impella family of heart pumps and looks forward to working with FDA to submit the necessary clinical data under the PMA application process.

SOURCE:
http://medcitynews.com/2012/12/abiomed-shares-lower-as-fda-panel-votes-to-retain-class-iii-status-for-impella/#ixzz2OUFvz168

Abiomed (NASDAQ: ABMD) is a pioneer and global leader in healthcare technology and innovation, with a mission of RECOVERING HEARTS AND SAVING LIVES. Abiomed CEO, Chairman, and President, Michael R. Minogue, has focused the company’s efforts on developing ground-breaking technologies designed to assist or replace the life-sustaining pumping function of the failing heart. The Company’s portfolio of products and services offer healthcare professionals an array of choices across a broad clinical spectrum.  From the world’s first total replacement heart to the World’s Smallest Heart Pump, 1/100th the size of the heart with rapid and simple insertion, Abiomed is dedicated to finding ways to bring the most advanced and beneficial technology to patients and physicians.

http://www.abiomed.com/about/about-abiomed/

Quick Facts

Company founded in 1981
Corporate Headquarters: Danvers, Massachusetts
European Division: Aachen, Germany
Number of Employees: 400+
NASDAQ Symbol: ABMD
Only company with FDA approval for heart recovery
First and only World’s Smallest Heart Pump
First Total Artificial Heart
Abiomed Announces Record Fourth Quarter Revenue of $37.3 Million, Up 31% and Achieves Profitability for Full Fiscal Year
DANVERS, Mass., May 16, 2012 (GLOBE NEWSWIRE) — Abiomed, Inc. (Nasdaq:ABMD – News), a leading provider of breakthrough heart support technologies, today reported fourth quarter fiscal 2012 revenue of $37.3 million, up 31% compared to revenue of $28.5 million in the same period of fiscal 2011, and GAAP net income of $2.6 million or $0.06 per diluted share compared to GAAP net loss of $1.8 million or a loss of $0.05 per basic and diluted share in the prior year. For the full fiscal year, total revenue was $126.4 million, up 25% compared to revenue of $101.2 million in the prior fiscal year and GAAP net income was $1.5 million or $0.04 per diluted share compared to GAAP net loss of $11.8 million or a loss of $0.32 per basic and diluted share in the prior year.

http://phx.corporate-ir.net/phoenix.zhtml?c=95629&p=irol-newsArticle&ID=1696354&highlight=

SYMPHONY – SYNCHRONIZED WORLD SMALLEST HEART PUMP ASSIST DEVICE                           [Symphony is not approved for use]

  • Promotes myocardial recovery/remodeling
  • Partial circulatory support device
  • Avoids issues with continuous full flow devices: GI bleeding, aortic valve dysfunction

Why Infraclavicular Fossa? 

  •  Most common site for device placement
  • Avoids thoracotomy/ sternotomy
  • Access to “central” circulation via subclavianartery
  • Previous or future sternotomiesnot an issue

DESIGN & OPERATION

  • An implantable, synchronized assist device
  • Placement in pacemaker pocket
  • Single graft to subclavianartery
  • Synchronized with subcutaneous EKG leads:Afterload reduction-Decreased LV work, Increases Cardiac Output, Increases coronary and systemic blood flow, Decreases filling pressure
  • Device output: 3.0 L/min at 100 bpm

PRODUCT POSITIONING

Meets goals for a less invasive, cost-effective partial assist device designed for recovery:

Improves hemodynamics, may improve QOL

Simple implantation, (No thoracotomy or sternotomy) -Pacemaker pocket

Simple device design, less costly/cost effective

Potential to optimize heart failure medications or future therapies (stem cell, pharma)

Designed to promote recovery with future explant (Promotes native heart recovery/remodeling with intent to explant)

Allows for short LOS and home discharge

 Limitations of current Heart Failure Therapy – Progression of disease impacts patient’s QOL

Prognosis poor with advanced heart failure

Limited heart transplant availability

Implantable LVADs require major operation, long hospitalizations, readmissions and are costly

No current implantable cardiac assist device has been designed for heart recovery/remodeling

SYMPHONY PROJECT STATUS 
  •  Early studies showed efficacy-NIH funding
  •  Over 90 bovine implants and 25 cadavers in development process
  •  Validated final device design
  •  Successful GLP pre-clinical study completed
  •  Ready for First in Man experience

SYMPHONY PRE-CLINICAL IMPLANTS

Bovine model with anastomosisto carotid artery

  • Mimics position in human implants
  • Initial studies showed efficacy in bovine heart failure model
  • Final GLP studies prior to first-in-man implants (n=6) 30 day implants, Warfarin(INR 2x baseline), anti-platelet therapy, full autopsies

Symphony: How it works

CURRENT PRODUCT PORTFOLIO

Impella: How it works

Impella 5.0 Axillary Insertion

Impella 5.0 Cut Down Insertion

Impella LD Insertion

Impella 2.5 Insertion

Automated Impella Controller

AB5000

REFERENCES on Importance of Cardiac Power Output (CPO)

Fincke R, Hochman JS, Lowe AM, et al. Cardiac Power Is The Strongest Hemodynamic Correlate of Mortality in Cardiogenic Shock: A Report From the SHOCK Trial Registry. J Am Coll Cardiol 2004;44(2):340-8

den Uil CA, Lagrand WK, van der Ent M, et al. Impaired Microcirculation Predicts Poor Outcome Of Patients With Acute Myocardial Infarction Complicated By Cardiogenic Shock. Eur Heart J 2010;31(24):3032-39

Mendoza DD, Cooper HA, Panza JA. Cardiac Power Output Predicts Mortality Across A Broad Spectrum Of Patients With Acute Cardiac Disease. Am Heart J 2007;153:366-70

Torgersen C, Schmittinger CA, Wagner S, et al. Hemodynamic Variables And Mortality In Cardiogenic Shock: A Retrospective Cohort Study. Crit Care 2009;13:R157

Torre-Amione G, Milo-Cotter O, Kaluski E, et al. Early Worsening Heart Failure In Patients Admitted For Acute Heart Failure: Time Course, Hemodynamic Predictors, And Outcome. J Card Fail 2009;15(8):639-44

Read Full Post »

Implantable Synchronized Cardiac Assist Device Designed for Heart Remodeling: Abiomed’s Symphony

Posted in Bio Instrumentation in Experimental Life Sciences Research, 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, Origins of Cardiovascular Disease, Pharmaceutical Industry Competitive Intelligence, Pharmacotherapy of Cardiovascular Disease, tagged , , , , on July 11, 2012| 4 Comments »

Implantable Synchronized Cardiac Assist Device Designed for Heart Remodeling: Abiomed’s Symphony

Reporter: Aviva Lev-Ari, PhD, RN

 

Abiomed (NASDAQ: ABMD) is a pioneer and global leader in healthcare technology and innovation, with a mission of RECOVERING HEARTS AND SAVING LIVES. Abiomed CEO, Chairman, and President, Michael R. Minogue, has focused the company’s efforts on developing ground-breaking technologies designed to assist or replace the life-sustaining pumping function of the failing heart. The Company’s portfolio of products and services offer healthcare professionals an array of choices across a broad clinical spectrum.  From the world’s first total replacement heart to the World’s Smallest Heart Pump, 1/100th the size of the heart with rapid and simple insertion, Abiomed is dedicated to finding ways to bring the most advanced and beneficial technology to patients and physicians.

http://www.abiomed.com/about/about-abiomed/

Quick Facts

Company founded in 1981
Corporate Headquarters: Danvers, Massachusetts
European Division: Aachen, Germany
Number of Employees: 400+
NASDAQ Symbol: ABMD
Only company with FDA approval for heart recovery
First and only World’s Smallest Heart Pump
First Total Artificial Heart
Abiomed Announces Record Fourth Quarter Revenue of $37.3 Million, Up 31% and Achieves Profitability for Full Fiscal Year
DANVERS, Mass., May 16, 2012 (GLOBE NEWSWIRE) — Abiomed, Inc. (Nasdaq:ABMD – News), a leading provider of breakthrough heart support technologies, today reported fourth quarter fiscal 2012 revenue of $37.3 million, up 31% compared to revenue of $28.5 million in the same period of fiscal 2011, and GAAP net income of $2.6 million or $0.06 per diluted share compared to GAAP net loss of $1.8 million or a loss of $0.05 per basic and diluted share in the prior year. For the full fiscal year, total revenue was $126.4 million, up 25% compared to revenue of $101.2 million in the prior fiscal year and GAAP net income was $1.5 million or $0.04 per diluted share compared to GAAP net loss of $11.8 million or a loss of $0.32 per basic and diluted share in the prior year.

http://phx.corporate-ir.net/phoenix.zhtml?c=95629&p=irol-newsArticle&ID=1696354&highlight=

SYMPHONY – SYNCHRONIZED WORLD SMALLEST HEART PUMP ASSIST DEVICE                           [Symphony is not approved for use]

  • Promotes myocardial recovery/remodeling
  • Partial circulatory support device
  • Avoids issues with continuous full flow devices: GI bleeding, aortic valve dysfunction

Why Infraclavicular Fossa? 

  •  Most common site for device placement
  • Avoids thoracotomy/ sternotomy
  • Access to “central” circulation via subclavianartery
  • Previous or future sternotomiesnot an issue

DESIGN & OPERATION

  • An implantable, synchronized assist device
  • Placement in pacemaker pocket
  • Single graft to subclavianartery
  • Synchronized with subcutaneous EKG leads:Afterload reduction-Decreased LV work, Increases Cardiac Output, Increases coronary and systemic blood flow, Decreases filling pressure
  • Device output: 3.0 L/min at 100 bpm

PRODUCT POSITIONING

Meets goals for a less invasive, cost-effective partial assist device designed for recovery:

Improves hemodynamics, may improve QOL

Simple implantation, (No thoracotomy or sternotomy) -Pacemaker pocket

Simple device design, less costly/cost effective

Potential to optimize heart failure medications or future therapies (stem cell, pharma)

Designed to promote recovery with future explant (Promotes native heart recovery/remodeling with intent to explant)

Allows for short LOS and home discharge

 Limitations of current Heart Failure Therapy – Progression of disease impacts patient’s QOL

Prognosis poor with advanced heart failure

Limited heart transplant availability

Implantable LVADs require major operation, long hospitalizations, readmissions and are costly

No current implantable cardiac assist device has been designed for heart recovery/remodeling

SYMPHONY PROJECT STATUS 
  •  Early studies showed efficacy-NIH funding
  •  Over 90 bovine implants and 25 cadavers in development process
  •  Validated final device design
  •  Successful GLP pre-clinical study completed
  •  Ready for First in Man experience

SYMPHONY PRE-CLINICAL IMPLANTS

Bovine model with anastomosisto carotid artery

  • Mimics position in human implants
  • Initial studies showed efficacy in bovine heart failure model
  • Final GLP studies prior to first-in-man implants (n=6) 30 day implants, Warfarin(INR 2x baseline), anti-platelet therapy, full autopsies

Symphony: How it works

CURRENT PRODUCT PORTFOLIO

Impella: How it works

Impella 5.0 Axillary Insertion

Impella 5.0 Cut Down Insertion

Impella LD Insertion

Impella 2.5 Insertion

Automated Impella Controller

AB5000

REFERENCES on Importance of Cardiac Power Output (CPO)

Fincke R, Hochman JS, Lowe AM, et al. Cardiac Power Is The Strongest Hemodynamic Correlate of Mortality in Cardiogenic Shock: A Report From the SHOCK Trial Registry. J Am Coll Cardiol 2004;44(2):340-8

den Uil CA, Lagrand WK, van der Ent M, et al. Impaired Microcirculation Predicts Poor Outcome Of Patients With Acute Myocardial Infarction Complicated By Cardiogenic Shock. Eur Heart J 2010;31(24):3032-39

Mendoza DD, Cooper HA, Panza JA. Cardiac Power Output Predicts Mortality Across A Broad Spectrum Of Patients With Acute Cardiac Disease. Am Heart J 2007;153:366-70

Torgersen C, Schmittinger CA, Wagner S, et al. Hemodynamic Variables And Mortality In Cardiogenic Shock: A Retrospective Cohort Study. Crit Care 2009;13:R157

Torre-Amione G, Milo-Cotter O, Kaluski E, et al. Early Worsening Heart Failure In Patients Admitted For Acute Heart Failure: Time Course, Hemodynamic Predictors, And Outcome. J Card Fail 2009;15(8):639-44

Read Full Post »

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