A judge in the England issued an injunction yesterday barring Edwards Lifesciences from selling its Pascal transcatheter mitral valve repair (TMVR) device in the U.K. A different judge had previously denied Abbott’s petition for such an injunction. Yesterday, Judge Colin Birss of the High Court of England and Wales also ruled that two patents held […]
Abbott wins CE Mark for FlexNav delivery system
Abbott (NYSE:ABT) announced today that it won CE Mark approval in Europe for the FlexNav delivery system for its Portico transcatheter aortic valve implantation (TAVI) system. The Abbott Park, Ill.-based company’s FlexNav delivery system is designed to offer another tool for doctors to treat patients requiring a transcatheter aortic valve implant by incorporating stability, predictability and […]
Neovasc to seek CE Mark for Tiara transapical mitral valve repair device
Neovasc (NSDQ:NVCN) announced that it plans to win CE Mark approval for its TA Tiara under the new European Medical Device Regulation (EU MDR) by 2021 or earlier. The company said it has treated 82 patients to date with the transapical (TA) Tiara mitral valve repair device. After reviewing the clinical data from its Tiara I […]
CryoLife wins CE Mark for ascending aortic prosthesis
CryoLife Inc. (NYSE:CRY) announced that it received CE Mark approval for the On-X ascending aortic prosthesis (AAP) for treating native or prosthetic heart valves in the aortic position involving an ascending aortic aneurysm. The approval allows for resumed distribution of the On-X AAP in Europe, as the product has been off the market there since late […]
Judge tosses Abbott’s bid to dismiss Tendyne investors’ $50m claim
Abbott (NYSE:ABT) has lost a bid to dismiss a lawsuit by former investors in Tendyne Holdings, who claim that the healthcare giant dragged its heels on obtaining a regulatory approval that would have triggered a $50 million milestone payment. Abbott in September 2015 paid $225 million up front for the stake it didn’t already own in […]
Cardiovalve scores FDA wins for its transcatheter tricuspid valve replacement tech
Cardiovalve (Or Yehuda, Israel) said today that U.S. FDA has granted a breakthrough device designation for its transcatheter tricuspid valve replacement system. FDA also approved an early feasibility study of the system for a tricuspid regurgitation (TR) indication. Cardiovalve touted that it is the first privately held company to have the FDA early feasability study […]
JenaValve raises $50m for TAVR tech
JenaValve Technology announced that it raised $50 million in equity financing as it develops and manufactures the JenaValve pericardial transcatheter aortic valve replacement (TAVR) system for treating aortic valve disease. Bain Capital Life Sciences led the funding round, while Andera Partners, Gimv, Legend Capital, NoMed Management, RMM, Valiance Life Sciences and VI Partners all participated, […]
Abbott wins FDA breakthrough nod for ventricular assist system
Abbott (NYSE:ABT) announced today that it won FDA breakthrough device designation for its in-development fully implantable left ventricular assist system (Filvas). According to a news release, left ventricular assist devices are implanted into the body and powered using an external battery pack or charging port. Abbott’s fully implantable device would require no external components, offering more […]
MIT engineers have created a bionic ‘heart’
Massachusetts Institute of Technology announced that engineers at the institute, along with others elsewhere, have collaborated to develop a bionic “heart” designed to offer a more realistic model for testing artificial valves and other devices. According to a report from MIT News, the device is a real biological heart which had its tough muscle tissue replaced […]
Edwards Lifescience boosts 2020 guidance amid strong TAVR sales
Edwards Lifesciences (NYSE:EW) saw its stock jump in after-hours trading today after the company boosted its 2020 guidance amid positive fourth-quarter TAVR sales. The Irvine, Calif.–based cardio device and critical care monitoring company’s Q4 results were mixed. But there was also the news that worldwide TAVR sales were up 30% year-over-year in Q4, to $763 million, […]
Abbott appears to be ahead in the TMVR race
Abbott (NYSE:ABT) announced today that its Tendyne transcatheter mitral valve implantation system has won CE Mark approval in Europe — touting the approval as a first. Industry insiders consider transcatheter mitral valve replacement as the next big thing after transcatheter aortic valve replacement (TAVR), with a potentially significant market for TMVR. The CE Mark for Tendyne […]
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