LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, has announced the first patient enrollment in the Perceval® Valve Clinical study for Chinese Registration (“PERFECT”) Trial. The study is a pre-market, prospective, single-arm trial. The PERFECT trial […]
Tag: Heart Valve
FDA Approves the World’s Smallest Mechanical Heart Valve for Pediatric Patients with Heart Defects
ABBOTT PARK, Ill., March 6, 2018 /PRNewswire/ — Abbott today announced the U.S. Food and Drug Administration (FDA) approved the Masters HP™ 15mm rotatable mechanical heart valve, the world’s smallest mechanical heart valve, that will allow doctors to treat babies and toddlers […]
FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world
SILVER SPRING, Md., March 6, 2018 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects. Specifically, […]
Edwards’ Self-Expanding Transcatheter Heart Valve Receives CE Mark
IRVINE, Calif., Feb. 15, 2018 /PRNewswire/ — Edwards Lifesciences(NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced it has received CE Mark for its self-expanding CENTERA valve for severe, symptomatic aortic stenosis […]
Xeltis Closes $52M for Replacement Heart Valve Programs
EINDHOVEN, The Netherlands and ZURICH, November 15, 2017 /PRNewswire/ — Xeltis, a clinical-stage medical device company pioneering a restorative approach in heart valve therapy, today announced the completion of an oversubscribed EUR45 million ($52 million) Series C financing. The funding […]
Cardiosolutions Key U.S. Patent Application For Adjustable “Spacer” Technology To Treat Heart Valve Regurgitation Receives Notice Of Allowance
WEST BRIDGEWATER, Mass., Sept. 18, 2017 /PRNewswire/ — Cardiosolutions, Inc., today announced that the United States Patent and Trademark Office has issued a Notice of Allowance to grant a key US patent covering the company’s proprietary ‘spacer’ technology for the treatment of […]
LivaNova (LIVN)’s Perceval Sutureless Aortic Heart Valve Awarded New Technology Add-On Payment From The Center For Medicare And Medicaid Services
LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, today announced its Perceval® sutureless aortic heart valve received approval from the Centers for Medicare and Medicaid Services (CMS) for a New Technology Add-on Payment (NTAP). The Perceval […]
Medtronic (MDT) Bags Approval for Avalus Valve in U.S. and Europe
DUBLIN – August 2, 2017 – Medtronic plc (NYSE: MDT) today announced CE (Conformité Européenne) mark and U.S. Food and Drug Administration (FDA) approval of its new Avalus(TM) pericardial aortic surgical valve for the treatment of aortic valve disease. The Avalus valve leverages […]
3-D Printed Models Could Improve Patient Outcomes in Heart Valve Replacements
Article ID: 677120 Released: 27-Jun-2017 11:45 AM EDT Source Newsroom: Georgia Institute of Technology Newswise — Heart valve models created with advanced 3-D printers could soon assist cardiologists in preparing to perform life-saving heart valve replacements. Researchers at Georgia Institute of Technology and […]
Edwards’ Novel Self-Expanding Transcatheter Heart Valve Demonstrates Excellent Early Patient Outcomes
PARIS, May 17, 2017 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced late-breaking data at EuroPCR 2017 demonstrating excellent clinical outcomes for transcatheter aortic valve replacement […]