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Archive for the ‘Cardiac and Cardiovascular Surgical Procedures’ Category


An Overview of the Heart Surgery Specialty: heart transplant, lung transplant, heart-lung transplantation, aortic valve surgery, bypass surgery, minimally invasive cardiac surgery, heart valve surgery, removal of cardiac tumors, reoperation valve surgery

Reporter: Aviva Lev-Ari, PhD, RN

Heart Transplant Surgeons at Cleveland Clinic:

http://my.clevelandclinic.org/transplant/services/heart/team.aspx

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

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

Treatment & Services

Specialty in Diseases and Conditions

 

 

One heart in 3 patients.

Source

Heart and Vascular Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates.

Abstract

In this report, we present a successful reuse of a transplanted heart under complex clinical conditions. Our patient was the second recipient, a 63-year-old man with end-stage heart failure due to amyloid-induced cardiomyopathy. After an uneventful postoperative course, he was diagnosed with acute myelogenous leukemia 6 months after transplantation and died 10 months after transplantation. This outcome was determined by a malignancy in an immunosuppressed patient. Reuse of a transplanted heart in carefully selected patients is a possible alternative in an era of donor organ shortage.

Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

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Experimental Therapy (Left inter-atrial shunt implant device) for Heart Failure: Expert Opinion on a Preliminary Study on Heart Failure with preserved Ejection Fraction 

 

Article Curator: Aviva Lev-Ari, PhD, RN

 

Expert Opinion by Cardiologist Justin D. Pearlman MD PhD FACC

 

Pearls From: Ted Feldman, MD – A glimmer of hope for HFpEF treatment?

Evanston Hospital in Illinois

by Nicole Lou, Contributing Writer, MedPage Today

SOURCE ARTICLE

https://www.medpagetoday.com/cardiology/chf/72759?xid=nl_mpt_DHE_2018-05-09

WATCH VIDEO

https://www.medpagetoday.com/cardiology/chf/72759?xid=nl_mpt_DHE_2018-05-09

 

Heart Failure with preserved Ejection Fraction (or HFpEF) – Experimental Therapy: Inter-atrial shunt implantable device for relieving pressure overload and improve the prognosis of patients with a 50% ejection fraction

vs

Heart Failure with reduced Ejection Fraction (HFrEF)

 

  • HFpEF is similar in frequency and sadly, similar in prognosis to heart failure with reduced ejection fraction, and everybody thinks about the EF 20% or 30% patient as having a poor prognosis and doesn’t realize that the EF 40% or 45% or 50% patient with clinical heart failure has the same prognosis.
  • Patients with mitral stenosis and elevated left atrial pressure, which is the genesis of HFpEF, if they had an ASD historically, this decompressed the left atrium and they presented much, much later in the course of the disease with any signs of heart failure.
  • Inspiration for design of the Left inter-atrial shunt implant device

Minimally invasive transcatheter closure is the primary treatment option for secundum atrial septal defects (ASD). The AMPLATZER™ Septal Occluder is the proven standard of care in transcatheter ASD closure

  • Left inter-atrial shunt implant device, Dr. Ted Feldman calls IASD.

It’s like an ASD occluder, a little nitinol disc, but it has a hole in the middle. We did some baseline hemodynamic modeling using a simulator and calculated that we would get a small shunt with an eight millimeter opening, that that would be enough to reduce left atrial pressure overload during exercise without overloading the right side of the heart, without creating too big a shunt.

Preliminary results: We found that peak exercise wedge pressure was significantly decreased in the patients with the device compared to those without a shunt. We found that the shunt ratio, the amount of flow across the shunt was a Qp:Qs, pulmonary to systemic flow ratio, of 1.2 preserved at 30 days and 6 months and that most of these patients feel better.

Ted Feldman, MD, Evanston Hospital in Illinois

The mechanism, I think we’ve established, that we do decompress the left atrium with exertion and now we need to demonstrate that the clinical outcomes in a larger population are robust enough to carry this into practice.

Expert Opinion by Cardiologist Justin D. Pearlman MD PhD FACC

  • It is a bit biased saying no treatment for CHD bias pEF, when there is support for so called triple therapy of beta blocker, acei/arb/arni, and aldosterone inhibitor, plus tight bp control and additional afterload reduction if valve leaks contribute.
  • It is an interesting proposition to induce an 8 mm IAS shunt, but it poses a risk for paradoxical emboli, which have been associated with
  1. visual field cuts,
  2. TIA and
  3. migraine.

Paradoxical Embolism

Updated: Jun 10, 2016
  • Author: Igor A Laskowski, MD; Chief Editor: Vincent Lopez Rowe, MD  more…
 Background

The clinical manifestations of paradoxical embolism (PDE) are nonspecific, [1and the diagnosis is difficult to establish. Patients with PDE may present with neurologic abnormalities or features suggesting arterial embolism. The disease starts with the formation of emboli within the venous system, which traverse a patent foramen ovale (PFO) and enter the systemic circulation. [234PFOs have been found on autopsy in up to 35% of the healthy population.

PDE originates in the veins of the lower extremities and occasionally in the pelvic veins. Emboli may be of various types, such as clots, air, tumor, fat, and amniotic fluid. [5Septic emboli have led to brain abscesses. Projectile embolization is rare (eg, from a shotgun pellet).

Management of PDE is both medical and surgical in nature. PDE is considered the major cause of cerebral ischemic events in young patients. On rare occasions, it may occlude the pelvic aortic bifurcation. The largest documented thrombus in a PFO (impending PDE) was 25 cm in length.

PDE is confirmed by the presence of thrombus within an intracardiac defect on contrast echocardiography or at autopsy. It may be presumed in the presence of arterial embolism with no evidence of left-side circulation thrombus, deep venous thrombosis (DVT) with or without pulmonary embolism (PE), and right-to-left shunting through an intracardiac communication, commonly the PFO. [6]

SOURCE for Paradoxical Embolism

https://emedicine.medscape.com/article/460607-overview

 

SOURCE for Dr. Pearlman’s Expert Opinion

From: Justin MDMEPhD <jdpmdphd@gmail.com>

Date: Wednesday, May 9, 2018 at 2:25 PM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Cc: “Dr. Larry Bernstein” <larry.bernstein@gmail.com>

Subject: Re: WHICH of our Heart Failure ARTICLES I should UPDATE with the following Pearls From: Ted Feldman, MD | Medpage Today

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Expanded Stroke Thrombectomy Guidelines: FDA expands treatment window for use (Up to 24 Hours Post-Stroke) of clot retrieval devices (Stryker’s Trevo Stent) in certain stroke patients

Reporter: Aviva Lev-Ari, PhD, RN

 

The stent retriever from Stryker was cleared for thrombectomy-eligible patients as initial therapy to reduce paralysis and other stroke disability only as an addition to tissue plasminogen activator (tPA). Previously, the device was approved only for use within 6 hours of ischemic stroke onset.

 

FDA Clears Trevo Stent Retriever for Up to 24 Hours Post-Stroke

FDA move follows expanded stroke thrombectomy guidelines

by Nicole Lou, Reporter, MedPage Today/CRTonline.org

“Time is critical following the onset of stroke symptoms. Expanding the treatment window from 6 to 24 hours will significantly increase the number of stroke patients who may benefit from treatment,” said Carlos Peña, PhD, director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health, in a statement. “Healthcare providers and their patients now have better tools for treating stroke and potentially preventing long-term disability.”

The American Heart Association and American Stroke Association recently revised their guidelines to recommend stent retriever use up to 24 hours after symptom onset. This was announced at the International Stroke Conference in January, where the DEFUSE 3 trial added to the evidence from DAWN in demonstrating benefits to relatively late endovascular thrombectomy.

In particular, DAWN data were used to support the FDA’s latest decision. Trial investigators had reported more functional independence when patients were randomized to Trevo thrombectomy over medical management alone.

SOURCE

https://www.medpagetoday.com/cardiology/strokes/71183

 

FDA expands treatment window for use of clot retrieval devices in certain stroke patients

For Immediate Release

February 15, 2018

Summary

FDA expands treatment window for use of clot retrieval devices in certain stroke patients

Release

The U.S. Food and Drug Administration today cleared the use of the Trevo clot retrieval device to treat certain stroke patients up to 24 hours after symptom onset, expanding the device’s indication to a broader group of patients. This device is cleared for use as an initial therapy for strokes due to blood clots (also known as an acute ischemic stroke) to reduce paralysis, speech difficulties and other stroke disabilities and only as an addition to treatment with a medication that dissolves blood blots called tissue plasminogen activator (t-PA). The device was previously cleared for use in patients six hours after symptom onset.

“Time is critical following the onset of stroke symptoms. Expanding the treatment window from 6 to 24 hours will significantly increase the number of stroke patients who may benefit from treatment,” said Carlos Peña, Ph.D., director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health. “Health care providers and their patients now have better tools for treating stroke and potentially preventing long-term disability.”

A stroke is a serious medical condition that requires emergency care and can cause lasting brain damage, long-term disability or even death. According to the Centers for Disease Control and Prevention, stroke is the fifth leading cause of death in the U.S. and is a major cause of serious disability for adults. About 795,000 people in the U.S. have a stroke each year. Ischemic strokes represent about 87 percent of all strokes.

The Trevo device was first cleared by the FDA in 2012 to remove a blood clot and restore blood flow in stroke patients who could not receive t-PA or for those patients who did not respond to t-PA therapy. In 2016, the FDA allowed expanded marketing of the device for certain patients in addition to treatment with t-PA if used within six hours of the onset of symptoms. Today’s expanded indication increases the amount of time that the device can be used once the symptoms are present.

Trevo is a clot removal device that is inserted through a catheter up into the blood vessel to the site of the blood clot. When the shaped section at the end of the device is fully expanded (up to three to six millimeters in diameter), it grips the clot, allowing the physician to retrieve the clot by pulling it back through the blood vessel along with the device for removal through a catheter or sheath.

The FDA evaluated data from a clinical trial comparing 107 patients treated with the Trevo device and medical management to 99 patients who had only medical management. About 48 percent of patients treated with the Trevo device were functionally independent (ranging from no symptoms to slight disability) three months after their stroke compared to 13 percent of patients who were not treated with the Trevo device.

Risks associated with using the Trevo device include a failure to retrieve the blood clot, embolization (blockage) to new territories in the brain, arterial dissections and vascular perforations, and access site complications at the femoral (thigh) artery entry point.

Trevo was reviewed through the premarket notification (510(k)) pathway. A 510(k) is a premarket submission made by device manufacturers to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. The FDA granted premarket clearance of the Trevo device to Concentric Medical Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596983.htm

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Renowned Electrophysiologist Dr. Arthur Moss Died on February 14, 2018 at 86

Reporter: Aviva Lev-Ari, PhD, RN

 

— Stephen

Dr. Moss never lost the opportunity to get to know who an individual is by name, to complement one, to greet one, to teach one, to be available, and to show respect. His contributions to clinical medicine, patient care and physician education, along with pivotal research, is among the ver most notable of our era. I will miss him greatly and extend my most heartfelt gratitude to him and his family.

Stephen Winters, MD
Morristown Medical Center

Comments Section

 

Renowned Cardiologist Arthur J. Moss, Pioneer of Research and Treatment in Sudden Death, Passes Away

Friday, February 16, 2018

Arthur J. Moss, M.D.

Arthur J. Moss, M.D.

Cardiologist Arthur J. Moss, whose research saved hundreds of thousands of lives and improved the standard of care for legions of people with heart disease, died on February 14, 2018. He was 86.

During a career spanning six decades, Moss made some of the most significant and long-lasting discoveries in the prevention and treatment of sudden cardiac death. His astounding accomplishments in scientific research and clinical care stemmed especially from his special devotion to patients; he understood the importance of listening, building trust and working together to bring about change. He was also a skilled leader, able to foster meaningful collaborations that led to some of the most productive clinical trials in all of cardiology.

“Arthur was a man of absolute integrity, both of science and of character, and an amazing visionary who could see where the field of electrophysiology was headed long before others,” said Wojciech Zareba, M.D., Ph.D.,director of the Heart Research Follow-up Program at the University of Rochester Medical Center, who worked closely with Moss for the past 26 years. “He was eternally optimistic in all aspects of his life; he brought a positive attitude to everything he did and didn’t worry about the small stuff, which helped him accomplish great things.”

In 1958, as an intern at Massachusetts General Hospital, Moss planned to pursue a career in hematology. That summer he was called to serve in the United States Navy. When he arrived in Pensacola, Fla., his commanding officers thought he was a cardiologist, for reasons unbeknownst to him. They asked Moss to teach flight surgeons electrocardiography, a test known as an EKG that checks the electrical activity of the heart. Undaunted, he read multiple books on the topic and taught them. The intricacy of the heart’s electrical activity captured Moss’ interest and he never looked back.

Moss spent the first half of his career figuring out which patients were at high risk of sudden cardiac death and the second half finding the best ways to treat them. He became an eminent authority on common arrhythmias that afflict hundreds of thousands of adults with heart disease and often lead to sudden death, as well as rare heart rhythm disorders that are smaller in number but no less deadly.

An unexpected patient visit in 1970 started what Moss called the most rewarding part of his career: his life-long quest to help individuals with Long QT syndrome (LQTS). Doctors could not understand why this patient – a woman in her 30s – would suddenly fall unconscious when she got excited while bowling. An unusual EKG led Moss, then a young cardiologist at URMC, to diagnose LQTS. An uncommon genetic condition caused by a glitch in the heart’s electrical system, LQTS puts patients at high risk of arrhythmias, fainting spells and sudden death.

Moss devised the first effective surgical treatment for the disorder and had the foresight to create the International Long QT Syndrome Registry in 1979, one of the first rare disease registries in the world. The registry allowed Moss and colleagues to identify risk factors that enable early diagnosis; develop multiple treatment options that have achieved an 80 percent reduction in life-threatening events; and contribute to the discovery of multiple genes associated with the disorder. The National Institutes of Health has supported the registry since its creation, and in 2014 Moss received a NIH grant to fund the registry and associated research projects through 2019.

“Not only was Arthur extraordinary in understanding the immediate problem, but he was also visionary in that long before we knew how to analyze genes he started the registry and preserved blood samples that could be used in the future,” said Mark B. Taubman, M.D., CEO of URMC and dean of the School of Medicine and Dentistry. “The registry has become one of the most important repositories in the world, helping prevent thousands of untimely deaths from Long QT and enabling the in-depth investigation of how genetics influence a form of heart disease. The impact of his work is unparalleled.”

Beginning in the 1990s, Moss led the MADIT (Multicenter Automatic Defibrillator Implantation Trial) series of clinical trials, which showed that the implantable cardioverter defibrillator or ICD – a device that detects arrhythmias and shocks the heart back into a normal rhythm – significantly reduces the risk of sudden death in patients who’ve experienced a heart attack. In the early 2000s these findings changed medical guidelines worldwide and led to the use of life-saving ICD therapy in hundreds of thousands of patients.

Later, in 2009, Moss completed the MADIT-CRT trial, which found that cardiac resynchronization therapy plus defibrillator – CRT-D therapy – prevents the progression of heart failure in patients living with mild forms of the disease. The device, which improves the mechanical pumping action of the heart and corrects fatal rhythms, was originally approved to treat patients with severe heart failure. Moss’ work opened the door for multitudes more patients to benefit and live longer, better lives.

“Arthur’s research was so successful and powerful because the results of his studies were usually strikingly positive or negative. This came from his rare ability to ask a simple question, and use a simple clinical trial design,” said Bradford C. Berk, M.D., Ph.D., professor of Medicine and Cardiology at URMC. “He did this so well because he was a superb clinician who had a remarkable insight into the underlying pathologic mechanisms of heart disease.”

Colleagues also credit Moss’ research success to his unique ability to bring people together, trigger discussion, and make all involved – from the highest-ranking physician to the newest graduate student or fellow – feel welcome and valued.

“I first met Art in 1976 and was at least three academic ranks lower than anyone else at the meeting,” said Henry (Hank) Greenberg, M.D., special lecturer of Epidemiology and Medicine at the Columbia University Medical Center. “Art sensed this and stated that everyone at the table contributed. This carried forward for four decades and was a reason why his trials were always superbly done. His ego did not get in the way.”

Moss was founding director of URMCs Heart Research Follow-up Program, a worldwide hub of international studies on medical interventions for sudden death, cardiac arrhythmias, heart attack and heart failure. He published more than 750 scientific papers, including a 1962 article – his first of many in the New England Journal of Medicine – highlighting the first three published cases of cardiopulmonary resuscitation (CPR), which included external chest massage followed by external defibrillation.

Charles J. Lowenstein, M.D., chief of Cardiology at URMC, said, “Arthur’s contributions to cardiac electrophysiology were vast and he was extremely well respected as a clinician and researcher. He also trained hundreds of medical students, residents, and fellows, and inspired many of us to dedicate our lives to medicine. This is his greatest legacy.”

Moss attended Yale as an undergraduate then Harvard Medical School. He interned at Massachusetts General Hospital and finished his residency in Rochester, where he also did a fellowship in cardiology. Moss joined the faculty at URMC in 1966 and stayed for the rest of his career, ultimately becoming  the Bradford C. Berk, M.D., Ph.D. Distinguished Professor in Cardiology. A valued member of the faculty, Moss received the Eastman Medal in 2012, the University of Rochester’s highest honor that recognizes individuals who, through their outstanding achievement and dedicated service, embody the high ideals for which the University stands.

On numerous other occasions, Moss was recognized locally, nationally and internationally for his tenacity and advancement of medical and cardiologic science. In 2008 he received the Glorney-Raisbeck Award in Cardiology, the highest honor of the New York Academy of Medicine. A year later he was awarded the prestigious Golden Lionel Award at the Venice International Cardiac Arrhythmias Meeting. The Heart Rhythm Society, the major international electrophysiology society, bestowed its top honor, the Distinguished Scientist Award, to Moss in 2011 and its Pioneer in Cardiac Pacing and EP Award to Moss in 2017.  

On November 11, 2017, just four months before his death, Moss was given the 2017 James B. Herrick Award at the American Heart Association’s Scientific Sessions. The award is given annually to a physician whose scientific achievements have contributed profoundly to the advancement and practice of clinical cardiology.

“Arthur’s passing is very sad news for the world of cardiology and clinical trials,” said David Cannom, director of Cardiology at Good Samaritan Hospital in Los Angeles. “There was no one quite like Arthur in terms of intelligence, judgement, leadership skills and thoughtful friendship. Plus good humor. An era is closing and he will be sorely missed.”  Other colleagues from around the world described him as a “true giant” in the field, a “role model,” and a “pioneer.”

Moss’s daughter Deborah, herself a physician, was always inspired by her dad’s curiosity, creativity and perseverance. “He paid close attention to his patients, their stories and their situations, and generated research questions that would make a difference not just for one patient, but for many patients. He was bold, never afraid to try something new, and wouldn’t stop until he solved a problem. Looking back on the entirety of his career, it was really incredible.”

Moss is survived by his wife Joy F. Moss, three children – Katherine M. Lowengrub, M.D., instructor in Psychiatry at the Sackler School of Medicine in Tel Aviv, Israel; Deborah R. Moss, M.D., M.P.H., associate professor of Pediatrics at the University of Pittsburgh Medical Center; and David A. Moss, Ph.D., professor at Harvard Business School – and nine grandchildren and two great-grandchildren. A memorial service will take place at Temple B’rith Kodesh on Elmwood Ave at 11 a.m. on Sunday, February 18. In lieu of flowers, donations may be sent to:

UR Heart Research Follow-Up Program

Alumni & Advancement Center

300 East River Rd. P.O. Box 270032

Rochester, NY 14627

SOURCE

https://www.urmc.rochester.edu/news/story/5273/renowned-cardiologist-arthur-j.-moss-pioneer-of-research-and-treatment-in-sudden-death-passes-away.aspx

His legacy is a career spanning more than 60 years that was marked by major contributions to cardiac electrophysiology, including the first surgical treatment for long QT syndrome and his leadership in the MADIT trials showing that an implantable cardioverter defibrillator could reduce the risk of sudden cardiac death.

Moss started his career in risk stratification studies and evaluating the potential of ventricular arrhythmias, according to longtime colleague Sanjeev Saksena, MD, past president of the North American Society of Pacing and Electrophysiology. Sakesna said that in 1983 Moss published “pivotal studies on risk stratification after myocardial infarction that led to his recognition as a leader in this field and was famously covered by TIME magazine for these contributions.”

Saksena also noted his early support of Michel Mirowski’s concept of an implanted standby defibrillator. This support, Saksena said “made him a lone voice arguing against the medical establishment more than 40 years ago for development of a therapy that is now a cornerstone of cardiovascular medicine.”

Douglas Zipes, MD, Past President, American College of Cardiology: “Wonderful man, scientist. He was the gold standard role model for the clinician investigator: he took care of patients and advanced the science of cardiology. A great loss, but his observations will live on.”

Robert Myerberg, MD, Professor of Medicine, University of Miami: “Art Moss had had an incredibly productive career. His dominant characteristic was a lack of fear of stepping into areas where there were gaps in our knowledge or untested hypotheses, and find a way to get us on to a path that would ultimately answer important and practical questions … His impact will continue to be felt long into the future. And on a personal level, his warmth and collegiality will be missed by his friends and colleagues.”

Bernard Gersh, MD, Professor of Medicine, Mayo Clinic: “Major contributions to our understanding of the long QT syndrome and the PI [principal investigator] of the major trials that established the clinical role of the ICD.”

Richard L. Page, MD, Chair, Department of Medicine, University of Wisconsin, School of Medicine & Public Health: “Arthur Moss was a consummate professional, gentleman, scholar, and physician. He was a role model for me and for a generation of cardiologists.”

Jagmeet P. Singh MD, Roman W. DeSanctis Endowed Chair in Cardiology, Massachusetts General Hospital Heart Center: “A huge loss for our community. He was my mentor.”

SOURCE

Eminent Cardiologist Arthur Moss Dies

Tributes to a giant in electrophysiology

https://www.medpagetoday.com/cardiology/arrhythmias/71227?xid=nl_mpt_cardiodaily_2018-02-20&eun=g99985d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=CDnews_022018&utm_term=AHA%20Cardiovascular%20Daily%20-%20Active%20Users%20180%20days

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FDA Approval marks first presentation of bivalirudin in frozen, premixed, ready-to-use formulation

Reporter: Aviva Lev-Ari, PhD, RN

 

Baxter Announces FDA Approval of Ready-to-Use Cardiovascular Medication Bivalirudin

Approval marks first presentation of bivalirudin in frozen, premixed, ready-to-use formulation

https://www.dicardiology.com/product/baxter-announces-fda-approval-ready-use-cardiovascular-medication-bivalirudin?eid=333021707&bid=1983307

Dosing and Uses

https://reference.medscape.com/drug/angiomax-angiox-bivalirudin-342137

 

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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

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

WASHINGTONMarch 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

Edwards Lifesciences, Valtech CardioEdwards 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

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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