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Mitral Valve Repair Global Leader: Edwards LifeSciences acquired Harpoon Medical for $250 in 12/2017 followed by $690 million buyout of Valtech Cardio 1/2017 and $400 million acquisition of CardiAQ Valve Technologies in 8/2016

Posted in Cardiac and Cardiovascular Surgical Procedures, Mitral Valve: Repair and Replacement on December 8, 2017| Leave a Comment »

Mitral Valve Repair Global Leader: Edwards LifeSciences acquired Harpoon Medical for $250 in 12/2017 followed by $690 million buyout of Valtech Cardio 1/2017 and $400 million acquisition of CardiAQ Valve Technologies in 8/2016

Reporter: Aviva Lev-Ari, PhD

UPDATED on 3/25

Edwards Prevails In U.S. Patent Office Review That Finds Boston Scientific Transcatheter Valve Patent Claims Invalid

WASHINGTON, March 23, 2018 — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the United States Patent and Trademark Office (USPTO) decided in Edwards’ favor in an Inter Partes Review (IPR) of Boston Scientific’s U.S. transcatheter heart valve patent, number 8,992,608 (the ‘608 patent). The USPTO determined that all claims of the ‘608 patent that have been asserted against Edwards are invalid.

The ‘608 patent was asserted against Edwards in a case filed by Boston Scientific in Delaware in 2016. Subsequently, Edwards asserted three of its own foundational transcatheter heart valve patents against Boston Scientific. The Edwards patent claims are unaffected by the USPTO’s ruling and will continue to trial, which is expected later in 2018.

Acquisitions of small players marks the ENTRY of Edwards LifeSciences into the Mitral Valve Repair Market, following MAJOR success in TAVR.

Harpoon Medical (trans apical approach) in 12/2017 and
CardiAQ Valve Technologies in 8/2016
$690 million buyout of Valtech Cardio, 1/2017 – It does not include Valtech Cardio’s trans-septal mitral valve replacement program; that business is slated to be spun out on its own before the buyout’s closing, expected in early 2017, but Edwards said last year that it’s due to keep an option to buy.

Edwards buys mitral valve repair player in $250M deal – Harpoon Medical

“The unique beating-heart repair procedure for mitral valve patients complements Edwards’ comprehensive portfolio of treatments for structural heart disease, and reinforces our commitment to innovation in cardiac surgery.”

The HARPOON system is designed to facilitate echo-guided repair of mitral valve regurgitation, by stabilizing the prolapsed mitral valve leaflet to restore proper coaptation and valve function. The HARPOON device is currently investigational and not available for commercial use. It is expected to receive CE Mark approval soon.

“There are a significant number of patients currently undergoing mitral valve surgery that we believe can benefit from Harpoon’s therapy during a minimally invasive, beating-heart procedure,” said device inventor James S. Gammie, M.D., chairman of the company’s scientific advisory board and professor and chief of cardiac surgery at the University of Maryland School of Medicine. “This therapy offers the potential for earlier treatment of degenerative mitral valve disease with faster recovery and less morbidity, while also providing the opportunity for more consistent procedures and outcomes for patients.”

Edwards will discuss the HARPOON technology further at its annual Investor Conference on Dec. 7.

Edwards Lifesciences closes $690m Valtech Cardio buy

JANUARY 24, 2017 BY BRAD PERRIELLO LEAVE A COMMENT

Edwards Lifesciences (NYSE:EW) said yesterday that it closed the $690 million buyout of Valtech Cardio and most of the heart valve repair technologies it’s developing.

Valtech makes the Cardioband device, which is designed to reshape the mitral valve using specially designed anchors.

The deal, announced in November 2016, calls for $340 million in up-front cash and another $350 million in milestones over 10 years. It does not include Valtech Cardio’s trans-septal mitral valve replacement program; that business is slated to be spun out on its own before the buyout’s closing, expected in early 2017, but Edwards said last year that it’s due to keep an option to buy.

Or Yehuda, Israel-based Valtech was the target of a previous takeover attempt by HeartWare International that was spiked early this year after a proxy war. (HeartWare itself was acquired by Medtronic (NYSE:MDT) for $1.1 billion in August.) Valtech won CE Mark approval in the European Union for Cardioband in September 2015 but the device is not approved for the U.S. market.

“We look forward to the Valtech team joining Edwards. We believe their knowledge, experience and the Cardioband technology are valuable additions to Edwards,” Edwards chairman & CEO Michael Mussallem said in prepared remarks.

Edwards Lifesciences bought CardiAQ Valve Technologies and its mitral valve device for $400 million last August.

Shares in Edwards have plummeted today in mid-day trading, down 9.1% at $89.06 as of 12:45 p.m. EST.

Last month, Edwards said it closed the $690 million buyout of Valtech Cardio and most of the heart valve repair technologies it’s developing.

Valtech makes the Cardioband device, which is designed to reshape the mitral valve using specially designed anchors.

The deal, announced in November 2016, calls for $340 million in up-front cash and another $350 million in milestones over 10 years. It does not include Valtech Cardio’s trans-septal mitral valve replacement program; that business is slated to be spun out on its own before the buyout’s closing, expected in early 2017, but Edwards said last year that it’s due to keep an option to buy.

SOURCE

http://www.massdevice.com/edwards-pauses-cardiaq-valve-clinical-trial-enrollment/

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Medical Devices Early Feasibility FDA’s Pathway – Accelerated Recruitment for Randomized Clinical Trials: Replacement and Repair of Mitral Valves

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cardiac and Cardiovascular Surgical Procedures, Mitral Valve: Repair and Replacement, Tricuspid Valve Repair on November 13, 2017| Leave a Comment »

Medical Devices Early Feasibility FDA’s Pathway – Accelerated Recruitment for Randomized Clinical Trials: Replacement and Repair of Mitral Valves

Reporter: Aviva Lev-Ari, PhD, RN

VIEW VIDEO

https://www.dicardiology.com/videos/video-update-mitral-valve-repair-and-replacement-technologies/5638263949001?eid=333021707&bid=1921231

HEART VALVE TECHNOLOGY | NOVEMBER 07, 2017

Ted Feldman, M.D., MSCAI FACC FESC, director of the cardiac cath lab, Evanston Hospital, explains the current state of transcatheter mitral valve technologies in development and in trials. He is involved in some of these trials and was the principal investigator for the pivotal MitraClip trial. Watch the VIDEO “Transcatheter Mitral Valve Technology, Anatomical Challenges” with Juan Granada, M.D.. Read the articles “Advances and Future Directions for Transcatheter Valves,” and “Transcatheter Mitral Valve Replacement Devices in Development.”

MitraClip
Cardioband

SOURCE

https://www.dicardiology.com/videos/video-update-mitral-valve-repair-and-replacement-technologies/5638263949001?eid=333021707&bid=1921231

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cell-free DNA (cfDNA) tests could become the ultimate “Molecular Stethoscope” that opens up a whole new way of practicing Medicine

Posted in Cancer - General, Diagnostic Immunology, Diagnostics and Lab Tests, Heart Transplant on September 8, 2017| Leave a Comment »

cell-free DNA (cfDNA) tests could become the ultimate “Molecular Stethoscope” that opens up a whole new way of practicing Medicine

Reporter: Aviva Lev-Ari, PhD, RN

The first commercial application of cfDNA sequencing debuted in 2011. New blood tests can identify Down’s syndrome and similar genetic conditions during the first months of pregnancy by checking the fetal DNA in the bloodstream of a pregnant woman. (Anywhere from 10 to 15 percent of the DNA in a pregnant woman’s blood comes from the placenta, which is genetically similar to the fetus.) These maternal blood tests are fast replacing less-accurate procedures, such as ultrasound plus blood analysis.

More recently, researchers have started looking at cfDNA to develop so-called liquid biopsies, which analyze a tumor’s genetic makeup or look for evidence of a cancer recurrence. Tumors often spill DNA into the blood as they grow and divide, and because they are usually riddled with mutations, their scrambled DNA is clearly different from that found in normal DNA fragments. The first liquid biopsy test was launched only three years ago; although they are not yet part of routine care, the field is growing quickly. One company says it will give liquid biopsy tests to one million people in the next five years, and another has raised nearly $1 billion for its studies.

A similar cfDNA method is being tested for newly transplanted organs, which are at risk of being rejected by the recipient’s immune system. Currently, transplant doctors check a transplanted organ’s health by performing repeated biopsies, which are expensive and invasive. After a transplant small amounts of donor DNA from the new heart or kidney, for example, circulate in the blood as part of the normal process of cell birth and death. If the host immune system attacks the foreign organ, the proportion of donor DNA increases as more and more foreign cells die. One company, CareDx, already sells a test that picks up on that change for people who have had kidney transplants.

The researchers invented a way to boost the signal by reducing human DNA in blood samples. Their spin-off company, Karius, launched a test earlier this year to identify bacteria, fungi, viruses or parasites in hospitalized patients. It can spot infections in organs that are too dangerous for biopsies, including the lung and the brain, Kertesz says—and it is most useful for people with mystery infections or who are too sick to endure a surgery.

cell-free DNA tests in the future include stroke, or autoimmune conditions such as lupus

SOURCE

One Test May Spot Cancer, Infections, Diabetes and More

Researchers are starting to diagnose more ailments using DNA fragments found in the blood

By Kat McGowan on September 5, 2017

https://www.scientificamerican.com/article/one-test-may-spot-cancer-infections-diabetes-and-more/

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Cleveland Clinic: Change at the Top, Tomislav “Tom” Mihaljevic, M.D., as its next CEO and President to succeed Toby Cosgrove, M.D., effective Jan. 1, 2018

Posted in Cardiac and Cardiovascular Surgical Procedures, Scientist: Career considerations, tagged minimally invasive and robotically assisted cardiac surgeries on September 1, 2017| Leave a Comment »

Cleveland Clinic: Change at the Top, Tomislav “Tom” Mihaljevic, M.D., as its next CEO and President to succeed Toby Cosgrove, M.D., effective Jan. 1, 2018

Reporter: Aviva Lev-Ari, PhD, RN

Cleveland Clinic’s Board of Governors and Board of Directors unanimously selected Dr. Mihaljevic based on the unanimous recommendation of a nomination committee chaired by Mr. Rich that conducted an extensive review of potential successors. Drs. Cosgrove and Mihaljevic will work on a transition process together through the end of the year. As of Jan. 1, 2018, Dr. Mihaljevic will assume the full duties of president and CEO, while Dr. Cosgrove will move to an advisory role to be determined by the Board of Directors and Dr. Mihaljevic.

A native of Croatia and a naturalized American citizen, Dr. Mihaljevic earned his medical degree from the University of Zagreb, before moving to the United States in 1995 to join Brigham and Women’s Hospital in Boston. He moved to Cleveland Clinic in 2004 as a cardiothoracic surgeon specializing in minimally invasive and robotically assisted cardiac surgeries – particularly robotic mitral valve repair – complex valve operations and reoperations, heart failure surgery, and heart transplantation. He helped to build Cleveland Clinic into the world’s largest robotic practice.

Dr. Mihaljevic has been on the editorial review board for prestigious medical journals. He is the author or co-author of more than 145 articles in medical and peer-reviewed scientific journals, and is the author of a numerous textbook chapters on robotic and minimally invasive mitral valve surgery, and heart valve disease. In 2005, Dr. Mihaljevic received a patent for a novel cardioscopy system for minimally invasive cardiac surgery. He earned the Cleveland Clinic Innovation Award in both 2006 and 2007.

Dr. Mihaljevic, 53, joined Cleveland Clinic in 2004 as a cardiothoracic surgeon specializing in minimally invasive and robotically assisted cardiac surgeries. Since 2015, Dr. Mihaljevic has served as CEO of Cleveland Clinic Abu Dhabi, overseeing the hospital’s strategy and operations as the first US multispecialty hospital to be replicated outside of North America, including directly managing the hospital’s Patient Experience and Strategy & Business Development programs.

Tomislav Mihaljevic, M.D.

“Dr. Mihaljevic brings a depth of experience, first as an innovative, world-class surgeon and more recently as a hospital executive focused on healthcare quality and safety, patient experience and business strategy,” said Robert E. Rich Jr., chair of Cleveland Clinic’s Board of Directors. “By nearly every measure – quality, accessibility, finances, innovation, reputation – Cleveland Clinic has made unprecedented strides since Dr. Cosgrove became CEO and president in 2004. Following in his footsteps would be challenging for anybody, but Dr. Mihaljevic has the background, skills and vision to move Cleveland Clinic forward to even greater heights.”

SOURCE

https://newsroom.clevelandclinic.org/2017/09/01/tomislav-mihaljevic-m-d-named-cleveland-clinic-ceo-president/

Articles on Minimally Invasive Surgery (MIS)

Cardiovascular Complications: Death from Reoperative Sternotomy after prior CABG, MVR, AVR, or Radiation; Complications of PCI; Sepsis from Cardiovascular Interventions

Author, Introduction and Summary: Justin D Pearlman, MD, PhD, FACC, and Article Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/23/cardiovascular-complications-of-multiple-etiologies-repeat-sternotomy-post-cabg-or-avr-post-pci-pad-endoscopy-andor-resultant-of-systemic-sepsis/

Less is More: Minimalist Mitral Valve Repair: Expert Opinion of Prem S. Shekar, MD, Chief, Division of Cardiac Surgery, BWH – #7, 2017 Disruptive Dozen at #WMIF17

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/05/17/less-is-more-minimalist-mitral-valve-repair-expert-opinion-of-prem-s-shekar-md-chief-division-of-cardiac-surgery-bwh-7-2017-disruptive-dozen-at-wmif17/

Left Main Coronary Artery Disease (LMCAD): Stents vs CABG – The less-invasive option is Equally Safe and Effective

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/12/06/left-main-coronary-artery-disease-lmcad-stents-vs-cabg-the-less-invasive-option-is-equally-safe-and-effective/

New method for performing Aortic Valve Replacement: Transmural catheter procedure developed at NIH, Minimally-invasive tissue-crossing – Transcaval access, abdominal aorta and the inferior vena cava

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/10/31/new-method-for-performing-aortic-valve-replacement-transmural-catheter-procedure-developed-at-nih-minimally-invasive-tissue-crossing-transcaval-access-abdominal-aorta-and-the-inferior-vena-cava/

Minimally Invasive Valve Therapy Programs: Recommendations by SCAI, AATS, ACC, STS

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/05/19/minimally-invasive-valve-therapy-programs-recommendations-by-scai-aats-acc-sts/

Mitral Valve Repair: Who is a Patient Candidate for a Non-Ablative Fully Non-Invasive Procedure?

Author, and Content Consultant to e-SERIES A: Cardiovascular Diseases: Justin Pearlman, MD, PhD, FACC and Article Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/11/04/mitral-valve-repair-who-is-a-candidate-for-a-non-ablative-fully-non-invasive-procedure/

Call for the abandonment of the Off-pump CABG surgery (OPCAB) in the On-pump / Off-pump Debate, +100 Research Studies

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/31/call-for-the-abandonment-of-the-off-pump-cabg-surgery-opcab-in-the-on-pump-off-pump-debate-100-research-studies/

3D Cardiovascular Theater – Hybrid Cath Lab/OR Suite, Hybrid Surgery, Complications Post PCI and Repeat Sternotomy

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/19/3d-cardiovascular-theater-hybrid-cath-labor-suite-hybrid-surgery-complications-post-pci-and-repeat-sternotomy/

Vascular Surgery: International, Multispecialty Position Statement on Carotid Stenting, 2013 and Contributions of a Vascular Surgeonat Peak Career – Richard Paul Cambria, MD

Author and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/14/vascular-surgery-position-statement-in-2013-and-contributions-of-a-vascular-surgeon-at-peak-career-richard-paul-cambria-md-chief-division-of-vascular-and-endovascular-surgery-co-director-thoracic/

Becoming a Cardiothoracic Surgeon: An Emerging Profile in the Surgery Theater and through Scientific Publications

Author and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/08/becoming-a-cardiothoracic-surgeon-an-emerging-profile-in-the-surgery-theater-and-through-scientific-publications/

Carotid Endarterectomy (CEA) vs. Carotid Artery Stenting (CAS): Comparison of CMMS high-risk criteria on the Outcomes after Surgery: Analysis of the Society for Vascular Surgery (SVS) Vascular Registry Data

Writer and Caurator: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/28/effect-on-endovascular-carotid-artery-repair-outcomes-of-the-cmms-high-risk-criteria/

Open Abdominal Aortic Aneurysm (AAA) repair (OAR) vs. Endovascular AAA Repair (EVAR) in Chronic Kidney Disease (CKD) Patients – Comparison of Surgery Outcomes

Writer and Curator: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/28/the-effect-of-chronic-kidney-disease-on-outcomes-after-abdominal-aortic-aneurysm-repair/

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SNP-based Study on high BMI exposure confirms CVD and DM Risks – no associations with Stroke

Posted in Atherogenic Processes & Pathology, BioBanking, BioIT: BioInformatics, BioIT: BioInformatics, NGS, Clinical & Translational, Pharmaceutical R&D Informatics, Clinical Genomics, Cancer Informatics, Biological Networks, Gene Regulation and Evolution, Biomarkers & Medical Diagnostics, Cardiac and Cardiovascular Surgical Procedures, Computational Biology/Systems and Bioinformatics, Diabetes Mellitus, Disease Biology, Epigenetics and Cardiovascular Risks, Frontiers in Cardiology and Cardiovascular Disorders, Genome Biology, Genomic Testing: Methodology for Diagnosis, HTN, Meta-analysis of transcriptome data, Origins of Cardiovascular Disease, Vascular Diseases on July 10, 2017| Leave a Comment »

SNP-based Study on high BMI exposure confirms CVD and DM Risks – no associations with Stroke

Reporter: Aviva Lev-Ari, PhD, RN

Genes Affirm: High BMI Carries Weighty Heart, Diabetes Risk – Mendelian randomization study adds to ‘burgeoning evidence’

by Crystal Phend, Senior Associate Editor, MedPage Today, July 05, 2017

The “genetically instrumented” measure of high BMI exposure — calculated based on 93 single-nucleotide polymorphisms associated with BMI in prior genome-wide association studies — was associated with the following risks (odds ratios given per standard deviation higher BMI):

Hypertension (OR 1.64, 95% CI 1.48-1.83)

Coronary heart disease (CHD; OR 1.35, 95% CI 1.09-1.69)

Type 2 diabetes (OR 2.53, 95% CI 2.04-3.13)

Systolic blood pressure (β 1.65 mm Hg, 95% CI 0.78-2.52 mm Hg)

Diastolic blood pressure (β 1.37 mm Hg, 95% CI 0.88-1.85 mm Hg)

However, there were no associations with stroke, Donald Lyall, PhD, of the University of Glasgow, and colleagues reported online in JAMA Cardiology.

The associations independent of age, sex, Townsend deprivation scores, alcohol intake, and smoking history were found in baseline data from 119,859 participants in the population-based U.K. Biobank who had complete medical, sociodemographic, and genetic data.

“The main advantage of an MR approach is that certain types of study bias can be minimized,” the team noted. “Because DNA is stable and randomly inherited, which helps to mitigate errors from reverse causality and confounding, genetic variation can be used as a proxy for lifetime BMI to overcome limitations such as reverse causality and confounding, a process that hampers observational analyses of obesity and its consequences.”

Primary Source

JAMA Cardiology

Source Reference: Lyall DM, et al “Association of body mass index with cardiometabolic disease in the UK biobank: A Mendelian randomization study” JAMA Cardiol 2017; doi:10.1001/jamacardio.2016.5804.
Secondary Source

JAMA Cardiology

Source Reference: O’Donnell CJ “Harnessing genomic biobanks to understand obesity in cardiometabolic disease prospects and pitfalls” JAMA Cardiol 2017; doi:10.1001/jamacardio.2016.5805.

9 results for Kindle Store : “Aviva Lev-Ari”

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Etiologies of Cardiovascular Diseases: Epigenetics, Genetics and Genomics

Nov 28, 2015 | Kindle eBook

by Justin D. Pearlman MD ME PhD MA FACC and Stephen J. Williams PhD

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Perspectives on Nitric Oxide in Disease Mechanisms (Biomed e-Books Book 1)

Jun 20, 2013 | Kindle eBook

by Margaret Baker PhD and Tilda Barliya PhD

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Cancer Therapies: Metabolic, Genomics, Interventional, Immunotherapy and Nanotechnology in Therapy Delivery (Series C Book 2)

May 13, 2017 | Kindle eBook

by Larry H. Bernstein and Demet Sag

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Metabolic Genomics & Pharmaceutics (BioMedicine – Metabolomics, Immunology, Infectious Diseases Book 1)

Jul 21, 2015 | Kindle eBook

by Larry H. Bernstein MD FCAP and Prabodah Kandala PhD

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Milestones in Physiology: Discoveries in Medicine, Genomics and Therapeutics (Series E: Patient-Centered Medicine Book 3)

Dec 26, 2015 | Kindle eBook

by Larry H. Bernstein MD FACP and Aviva Lev-Ari PhD RN

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Genomics Orientations for Personalized Medicine (Frontiers in Genomics Research Book 1)

Nov 22, 2015 | Kindle eBook

by Sudipta Saha PhD and Ritu Saxena PhD

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Cancer Biology and Genomics for Disease Diagnosis (Series C: e-Books on Cancer & Oncology Book 1)

Aug 10, 2015 | Kindle eBook

by Larry H Bernstein MD FCAP and Prabodh Kumar Kandala PhD

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Regenerative and Translational Medicine: The Therapeutic Promise for Cardiovascular Diseases

Dec 26, 2015 | Kindle eBook

by Justin D. Pearlman MD ME PhD MA FACC and Stephen J. Williams

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Cardiovascular Original Research: Cases in Methodology Design for Content Co-Curation: The Art of Scientific & Medical Curation

Nov 29, 2015 | Kindle eBook

by Larry H. Bernstein MD FCAP and Aviva Lev-Ari PhD RN

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Spectranetics, a Technology Leader in Medical Devices for Coronary Intervention, Peripheral Intervention, Lead Management to be acquired by Philips for 1.9 Billion Euros

Posted in Cardiac and Cardiovascular Surgical Procedures, PCI, Peripheral Arterial Disease & Peripheral Vascular Surgery on June 28, 2017| Leave a Comment »

Spectranetics, a Technology Leader in Medical Devices for Coronary Intervention, Peripheral Intervention, Lead Management to be acquired by Philips for 1.9 Billion Euros

Reporter and Curator: Aviva Lev-Ari, PhD, RN

BUSINESS NEWS | Wed Jun 28, 2017 | 10:53am BST

Philips to buy medical device maker Spectranetics for 1.9 billion euros

By Toby Sterling | AMSTERDAM

Dutch healthcare company Philips (PHG.AS) has agreed to buy U.S.-based Spectranetics Corp (SPNC.O), a maker of devices to treat heart disease, for 1.9 billion euros (£1.68 billion) including debt, as it expands its image-guided therapy business.

Spectranetics uses techniques including lasers and tiny drug-covered balloons to clean the insides of veins and arteries that have become clogged due to heart disease.

Philips will pay Spectranetics shareholders $38.50 per share, a 27 percent premium to their closing price on June 27.

Philips Chief Executive Frans van Houten has transformed the former conglomerate into a focused maker of healthcare equipment over the past five years, spinning off its lighting division (LIGHT.AS) and selling most of its remaining consumer products business.

Philips said Spectranetics, which expects sales of around $300 million this year, will continue to grow revenues at double-digit rates and will begin adding to Philips’ earnings in 2018.

SOURCE

http://uk.reuters.com/article/uk-spectranetics-m-a-philips-idUKKBN19J0MZ?em_pos=small&ref=headline&nl_art=1

http://www.spectranetics.com/about/overview/

http://www.spectranetics.com/about/history/

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Coronary Artery Disease (CAD) is the leading cause of death among men and women. Each year, one in four deaths are attributed to CAD in the United States, accounting for over a half million lives lost. From scoring balloon technology to laser atherectomy to thrombus aspiration and removal, Spectranetics offers a comprehensive portfolio of solutions to cross, prep and treat compromised vessels. Learn more about CAD by navigating through the tile grid below and exploring the products that are saving lives.

SOURCE

http://www.spectranetics.com/solutions/coronary-intervention/

Spectranetics is dedicated to helping physicians cross, prep and treat complex clinical challenges of Peripheral Artery Disease, such as Critical Limb Ischemia, Chronic Total Occlusions and In-Stent Restenosis. We provide expert tools, training, ongoing support and patient education so that you can help eradicate restenosis, and amputation and modify all plaque. Explore the tile grid below to learn more about Peripheral Artery Disease and Spectranetics’ comprehensive portfolio of products to successfully treat this challenging cardiovascular condition at every stage.

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SOURCE

http://www.spectranetics.com/solutions/peripheral-intervention/

Managing cardiac implantable electronic device (CIED) leads has never been more important. Patients with CIEDs are on a lifelong journey, and Spectranetics is there to make sure it’s a healthy one. Making the right decision at the right time, for every patient, is critical. Lives depend on it. Explore the tile grid below to learn more about Lead Management and the products that ensure lead extraction is done safely, responsibly and predictably.

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SOURCE

http://www.spectranetics.com/solutions/lead-management/

60 Articles on Peripheral Artery Disease (PAD)

https://pharmaceuticalintelligence.com/category/cardiac-and-cardiovascular-surgical-procedures/peripheral-arterial-disease-peripheral-vascular-surgery/

86 Articles on PCI

https://pharmaceuticalintelligence.com/category/cardiac-and-cardiovascular-surgical-procedures/pci/

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Off-Label TAVR Procedures: 1 in 10 associated with higher in-hospital 30-day mortality, 1-year mortality was similar in the Off-Lavel and the On-Label groups

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery on June 22, 2017| Leave a Comment »

Off-Label TAVR Procedures: 1 in 10 associated with higher in-hospital 30-day mortality, 1-year mortality was similar in the Off-Label and the On-Label groups

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 7/10, 2017

FDA clears Medtronic’s CoreValve Evolut TAVR in intermediate risk patients

JULY 10, 2017 BY FINK DENSFORD

http://www.massdevice.com/fda-clears-medtronics-corevalve-evolut-tavr-in-intermediate-risk-patients/?spMailingID=11443122&spUserID=MTU0MTAzNDg3OTA5S0&spJobID=1200865729&spReportId=MTIwMDg2NTcyOQS2

by Nicole Lou, Reporter, MedPage Today/CRTonline.org June 21, 2017

Action Points

Off-label transcatheter aortic valve replacement (TAVR) was associated with higher in-hospital, 30-day, and 1-year mortality rates compared with on-label TAVR use, but after adjustment, 1-year mortality was similar in the two groups.
Note that approximately one in 10 TAVR patients in the United States have received the procedure for an off-label indication.

Three-quarters of off-label indications were deemed so due to presence of severe aortic or mitral regurgitation or both; one-fifth were off-label because of bicuspid valves.

Successful device implantation was slightly less likely with off-label TAVR (92.9% versus 93.0%, P=0.02). But in-hospital outcomes were the bigger issue for off- versus on-label TAVR:

Mortality (6.3% versus 4.7%, P<0.001)
Cardiac arrest (6.6% versus 4.8%, P<0.001)
Transient ischemic attack (0.5% versus 0.2%, P=0.007)
Moderate-to-severe perivalvular leaks (12.4% versus 7.6%, P<0.001)

Mortality was most likely for patients with severe mitral regurgitation as the only off-label indication for TAVR. The authors suggested this is owing to secondary mitral regurgitation caused by left ventricular dilatation.

SOURCE

1 in 10 TAVR Procedures Done Off-Label Despite early risks vs on-label use, ‘acceptable results’ cited from registry

Reviewed by Henry A. Solomon, MD, FACP, FACC Cinical Associate Professor, Weill Cornell Medical College and Dorothy Caputo, MA, BSN, RN, Nurse Planner

https://www.medpagetoday.com/Cardiology/CHF/66173?xid=nl_mpt_DHE_2017-06-22&eun=g99985d0r&pos=1

Primary Source

JAMA Cardiology

Source Reference: Hira RS, et al “Trends and outcomes of off-label use of transcatheter aortic valve replacement: insights from the NCDR STS/ACC TVT Registry” JAMA Cardiol 2017; DOI: 10.1001/jamacardio.2017.1685.
Secondary Source

JAMA Cardiology

Source Reference: Joynt KE and Kramer DB “Off-label use of high-risk cardiovascular devices: widening the lens” JAMA Cardiol 2017; DOI: 10.1001/jamacardio.2017.1732.
Additional Source

JAMA Cardiology

Source Reference: Califf RM “Evaluating evolving technologies in a time of rapid change: the case of transcatheter aortic valve replacement” JAMA Cardiol 2017; DOI: 10.1001/jamacardio.2017.1733.

Right Internal Carotid Artery Clot Aspiration: 4.5 Minute Thrombectomy Using the ADAPT-FAST Technique and the ACE68 Catheter

Posted in Carotid Artery on May 17, 2017| Leave a Comment »

Right Internal Carotid Artery Clot Aspiration: 4.5 Minute Thrombectomy Using the ADAPT-FAST Technique and the ACE68 Catheter

Reporter: Aviva Lev-Ari, PhD, RN

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http://mus.2.broadcastmed.net/videos/4-5-minute-thrombectomy-using-the-adapt-fast-technique-and-the-ace68-catheter?utm_source=social&utm_medium=facebook&utm_content=Thrombectomy&utm_campaign=mus_7952

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Less is More: Minimalist Mitral Valve Repair: Expert Opinion of Prem S. Shekar, MD, Chief, Division of Cardiac Surgery, BWH – #7, 2017 Disruptive Dozen at #WMIF17

Posted in Cardiac and Cardiovascular Surgical Procedures, Interviews with Scientific Leaders, Mitral Valve: Repair and Replacement, PCI on May 17, 2017| Leave a Comment »

Less is More: Minimalist Mitral Valve Repair: Expert Opinion of Prem S. Shekar, MD, Chief, Division of Cardiac Surgery, BWH – #7, 2017 Disruptive Dozen at #WMIF17

Reporter: Aviva Lev-Ari, PhD, RN

Article ID #235: Less is More: Minimalist Mitral Valve Repair: Expert Opinion of Prem S. Shekar, MD, Chief, Division of Cardiac Surgery, BWH – #7, 2017 Disruptive Dozen at #WMIF17. Published on 5/17/2017

WordCloud Image Produced by Adam Tubman

Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES

11:45 am – 12:45 pm
Boston Scientific Ballroom

Disruptive Dozen: 12 Technologies that will reinvent Cardiovascular Care

Moderator: Calum MacRae, MD, PhD

Chief of Cardiovascular Medicine, Brigham and Women’s Hospital
Associate Professor of Medicine, Harvard Medical School

Anthony Rosenzweig, MD

Chief, Cardiology Division, Massachusetts General Hospital
Professor of Medicine, Harvard Medical School

12. Aging and Heart Disease: Can we reverse the process?

11.Nanotechnologies for Cardiac Diagnosis and Treatment

10. Breaking the Code: Diagnosis and Therapeutic Potential of RNA

9. Expanding the Pool of Organs for Transplant

8. Finding Cancer therapies without Cardiotoxicity

7. Less is more: Minimalist Mitral Valve Repair

6. Understanding Why exercise works for Just about every thing

5. Power Play: The Future of Implantable Cardiac Devices

4. Adopting the Orphan of Heart Disease

3. Targeting Inflammation in cardiovascular Disease

2. Harnessing Big Data and Deep Learning for Clinical Decision Support

Quantitative Molecular Imaging for Cardiovascular Phynotypes

SOURCE

Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES

Excerpts from Prem S. Shekar, MD Presentation

The success achieved with TAVR

least traumatic
short recovery
quicker return to normal lifestyle

encouraged Medical devices Manufacturers to develop Mitral Valve Repair technologies to address the large unmet need for percutaneous treatment of patients with Mitral Valve disease:

Mild or Severe (4 Million in the US, alone).

Mitral Regurgitation (MR) – imperfect closure of the valve permits blood from LV to return back towards the lungs.

Causes for MR

the degenerative myxomatous disease
senile calcific degenerative disease causing enlargement of the LV, infection or Trauma.

Mitral stenosis – narrowing of the valve

Causes for Mitral Stenosis

rheumatic fever
senile calcific degeneration – obstruction to the forward flow of blood resulting in increased fluid pressure inside the lungs.

Symptoms of MR – managed by drugs or Surgery for correction (Open Heart surgery or MIS – both procedures require use of bypass machine, the heart been stopped for the duration of repair/replacement) for Valve Repair or Valve Replacement

shortness of breath
fatigue

Uncorrected Mitral Valve disease can lead to

irregular heart rhythms
increased risk for stroke
CHF
Death

Transcatheter Mitral Valve Correction

Valve replacement
use of Repair devices on the Mitral leaflets
implantation of neochords
remodeling of the mitral annulus

Comparison of TARV with Transcatheter Mitral Valve Correction

Aortic Valve vs Mitral Valve: difference in complexity and artistic nature of Mitral repair
Ability to perform a Percutaneous repair on a Mitral Valve with same degree of accuracy and reproducibility as a Percutaneous repair on an Aortic Valve — will remain a challenge.
development of advance imaging technologies will play a key role in achieveing success with Percutaneous repair on a Mitral Valve
Percutaneous repair on a Mitral Valve need to overcome the complex structure and integrated relationship with the LV.

Leading Challenges in the Development of Percutaneous repair on a Mitral Valve Technologies

Mitral is a bigger Valve than the Aortic
It is more difficult to access
It is Asymmetrical
It lacks an anatomically well-defined annulus to which to anchor the artificial valve
Its geometry changes throughout the cardiac cycle
Placement of a replacement valve bears the risk of LV outflow tract obstruction

Patient Candidate Profile forPercutaneous repair on a Mitral Valve

Patient with a failed Mitral Valve bioprosthesis – Severe Mitral Valve Disease
Failed Mitral Valve Repairs
Senile calcific degeneration
Mitral Regurgitation unmanaged by medication
Variable surgical risk related to co-morbidities

Search Category:

Cardiovascular Medical Devices: Cardiac Surgery, Cardiothoracic Surgical Procedures and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty – 248 articles

Mitral Valve Repair: Who is a Patient Candidate for a Non-Ablative Fully Non-Invasive Procedure? – Last Updated on 4/8/2017

Justin Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN

Lev-Ari, A. 5/19/2014. Transcatheter Mitral Valve (TMV) Procedures: Centers for Medicare & Medicaid Services (CMS) proposes to cover Transcatheter Mitral Valve Repair (TMVR)

Transcatheter Mitral Valve (TMV) Procedures: Centers for Medicare & Medicaid Services (CMS) proposes to cover transcatheter mitral valve repair (TMVR)

Lev-Ari, A. 1/26/2014. Transcatheter Valve Competition in the United States: Medtronic CoreValve infringes on Edwards Lifesciences Corp. Transcatheter Device Patents

https://pharmaceuticalintelligence.com/2014/01/26/transcatheter-valve-competition-in-the-united-states-medtronic-corevalve-infringes-on-edwards-lifesciences-corp-transcatheter-device-patents/

Lev-Ari, A. 1/26/2014. Developments on the Frontier of Transcatheter Aortic Valve Replacement (TAVR) Devices

https://pharmaceuticalintelligence.com/2014/01/26/developments-on-the-frontier-of-transcatheter-aortic-valve-replacement-tavr-devices/

Larry H. Bernstein and Aviva Lev-Ari 6/23/2013 Survivals Comparison of Coronary Artery Bypass Graft (CABG) and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty

https://pharmaceuticalintelligence.com/2013/06/23/comparison-of-cardiothoracic-bypass-and-percutaneous-interventional-catheterization-survivals/

Larry H Bernstein and Lev-Ari, A. 6/23/2013 First case in the US: Valve-in-Valve (Aortic and Mitral) Replacements with Transapical Transcatheter Implants – The Use of Transfemoral Devices.

https://pharmaceuticalintelligence.com/2013/06/23/valve-in-valve-replacements-with-transapical-transcatheter-implants/

Larry H Bernstein and Lev-Ari, A. 6/17/2013 Transcatheter Aortic Valve Replacement (TAVR): Postdilatation to Reduce Paravalvular Regurgitation During TAVR with a Balloon-expandable Valve

https://pharmaceuticalintelligence.com/2013/06/17/postdilatation-to-reduce-paravalvular-regurgitation-during-transcatheter-aortic-valve-replacement/ 

Larry H Bernstein and Lev-Ari, A. 6/17/2013 Trans-apical Transcatheter Aortic Valve Replacement in a Patient with Severe and Complex Left Main Coronary Artery Disease (LMCAD)

https://pharmaceuticalintelligence.com/2013/06/17/management-of-difficult-trans-apical-transcatheter-aortic-valve-replacement-in-a-patient-with-severe-and-complex-arterial-disease/ 

Larry H Bernstein and Lev-Ari, A. 6/18/2013 Ventricular Assist Device (VAD): A Recommended Approach to the Treatment of Intractable Cardiogenic Shock

https://pharmaceuticalintelligence.com/2013/06/18/a-recommended-approach-to-the-treatmnt-of-intractable-cardiogenic-shock/

Larry H Bernstein and Lev-Ari, A.6/20/2013 Phrenic Nerve Stimulation in Patients with Cheyne-Stokes Respiration and Congestive Heart Failure

https://pharmaceuticalintelligence.com/2013/06/20/phrenic-nerve-stimulation-in-patients-with-cheyne-stokes-respiration-and-congestive-heart-failure/

Lev-Ari, A. 2/12/2013 Clinical Trials on transcatheter aortic valve replacement (TAVR) to be conducted by American College of Cardiology and the Society of Thoracic Surgeons

https://pharmaceuticalintelligence.com/2013/02/12/american-college-of-cardiologys-and-the-society-of-thoracic-surgeons-entrance-into-clinical-trials-is-noteworthy-read-more-two-medical-societies-jump-into-clinical-trial-effort-for-tavr-tech-f/

Lev-Ari, A. 12/31/2012 Renal Sympathetic Denervation: Updates on the State of Medicine

https://pharmaceuticalintelligence.com/2012/12/31/renal-sympathetic-denervation-updates-on-the-state-of-medicine/

Lev-Ari, A. 9/2/2012 Imbalance of Autonomic Tone: The Promise of Intravascular Stimulation of Autonomics

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

Lev-Ari, A. 8/13/2012Coronary Artery Disease – Medical Devices Solutions: From First-In-Man Stent Implantation, via Medical Ethical Dilemmas to Drug Eluting Stentshttps://pharmaceuticalintelligence.com/2012/08/13/coronary-artery-disease-medical-devices-solutions-from-first-in-man-stent-implantation-via-medical-ethical-dilemmas-to-drug-eluting-stents/

Lev-Ari, A. 7/18/2012Percutaneous Endocardial Ablation of Scar-Related Ventricular Tachycardia

https://pharmaceuticalintelligence.com/2012/07/18/percutaneous-endocardial-ablation-of-scar-related-ventricular-tachycardia/

Lev-Ari, A. 6/13/2012Treatment of Refractory Hypertension via Percutaneous Renal Denervation

https://pharmaceuticalintelligence.com/2012/06/13/treatment-of-refractory-hypertension-via-percutaneous-renal-denervation/

Lev-Ari, A. 6/22/2012Competition 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)

https://pharmaceuticalintelligence.com/2012/06/22/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/

Lev-Ari, A. 6/19/2012Executive 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

https://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/

Lev-Ari, A. 6/22/2012Global 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

https://pharmaceuticalintelligence.com/2012/06/22/global-supplier-strategy-for-market-penetration-partnership-options-niche-suppliers-vs-national-leaders-in-the-massachusetts-cardiology-vascular-surgery-tools-and-devices-market-for-car/

Lev-Ari, A. 7/23/2012Heart Remodeling by Design: Implantable Synchronized Cardiac Assist Device: Abiomed’s Symphony

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

Lev-Ari, A. (2006b). First-In-Man Stent Implantation Clinical Trials & Medical Ethical Dilemmas. Bouve College of Health Sciences, Northeastern University, Boston, MA 02115

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

Posted in Cardiac and Cardiovascular Surgical Procedures, Conference Coverage with Social Media, Frontiers in Cardiology and Cardiovascular Disorders on May 5, 2017| Leave a Comment »

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

Curator: Aviva Lev-Ari, PhD, RN

@pharma_BI

@AVIVA1950

Archive for the ‘Cardiac and Cardiovascular Surgical Procedures’ Category

Mitral Valve Repair Global Leader: Edwards LifeSciences acquired Harpoon Medical for $250 in 12/2017 followed by $690 million buyout of Valtech Cardio 1/2017 and $400 million acquisition of CardiAQ Valve Technologies in 8/2016

Edwards Prevails In U.S. Patent Office Review That Finds Boston Scientific Transcatheter Valve Patent Claims Invalid

Edwards buys mitral valve repair player in $250M deal – Harpoon Medical

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Medical Devices Early Feasibility FDA’s Pathway – Accelerated Recruitment for Randomized Clinical Trials: Replacement and Repair of Mitral Valves

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SNP-based Study on high BMI exposure confirms CVD and DM Risks – no associations with Stroke

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Spectranetics, a Technology Leader in Medical Devices for Coronary Intervention, Peripheral Intervention, Lead Management to be acquired by Philips for 1.9 Billion Euros

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Off-Label TAVR Procedures: 1 in 10 associated with higher in-hospital 30-day mortality, 1-year mortality was similar in the Off-Label and the On-Label groups

FDA clears Medtronic’s CoreValve Evolut TAVR in intermediate risk patients

Action Points

Primary Source

JAMA Cardiology

Secondary Source

JAMA Cardiology

Additional Source

JAMA Cardiology

Other related TAVR articles published in this Open Access Online Scientific Journal included the following 64 articles:

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Right Internal Carotid Artery Clot Aspiration: 4.5 Minute Thrombectomy Using the ADAPT-FAST Technique and the ACE68 Catheter

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Less is More: Minimalist Mitral Valve Repair: Expert Opinion of Prem S. Shekar, MD, Chief, Division of Cardiac Surgery, BWH – #7, 2017 Disruptive Dozen at #WMIF17

Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017 BOSTON, MA • UNITED STATES

Excerpts from Prem S. Shekar, MD Presentation

Transcatheter Mitral Valve Correction

Comparison of TARV with Transcatheter Mitral Valve Correction

Leading Challenges in the Development of Percutaneous repair on a Mitral Valve Technologies

Patient Candidate Profile forPercutaneous repair on a Mitral Valve

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Mitral Valve Repair: Who is a Patient Candidate for a Non-Ablative Fully Non-Invasive Procedure? – Last Updated on 4/8/2017

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

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