Boston Scientific (NYSE:BSX) said today that it won CE Mark approval in the European Union for the next iteration of its Watchman anti-stroke heart implant. The Marlborough, Mass.-based medical device maker said the Watchman FLX is designed to be easier to implant during procedures to occlude the left atrial appendage and is re-capturable and re-positionable intraprocedurally. […]
Cardiac Implants
Edwards Lifesciences gets in on Corvia, Mitralign
Edwards Lifesciences (NYSE:EW) said today that it made a pair of strategic bets on the structural heart space, paying $35 million for the right to acquire Corvia Medical and paying an unspecified amount for some of mitral valve repair device maker Mitralign‘s assets. Tewksbury, Mass.-based Corvia is developing an interatrial shunt to treat heart failure by […]
Catheter OEM Oscor gets in on $20m Series D for Micro Interventional Devices
Micro Interventional Devices said today that contract manufacturer Oscor led its $20 million Series D round and inked an OEM deal. Newtown, Pa.-based MID said the deal involves a non-exclusive license for Palm Harbor, Fla.-based Oscor’s catheter technology, in return for Oscor’s exclusive right to its MID’s Mia device for treating tricuspid and mitral valve […]
Study finds fault with ICD leads that Abbott inherited from St. Jude Medical
A review of FDA adverse event reports has revealed that some Abbott (NYSE:ABT) implantable cardioverter defibrillator (ICD) leads were much more likely than those made by Boston Scientific or Medtronic to fail due to internal insulation breaches (IBR). Researchers at the Minneapolis Heart Institute Foundation combed through the FDA MAUDE database from 2008 to 2018 for reports […]
CorMatrix launches FDA IDE Cor Tricuspid ECM cardiac valve trial
CorMatrix Cardiovascular said today that it launched a trial of its Cor Tricuspid ECM cardiac valve intended for treating adults with endocarditis and pediatric patients with congenital heart valve disease, adding that the first patient in the trial has already been treated. The first procedure in the trial took place at the Francicscan Health Heart Center […]
FDA green-lights early feasibility trial for Foldax’s Tria biopolymer heart valve
Early stage cardiovascular device company Foldax said today it won FDA investigational device exemption approval to launch an early feasibility study of its Tria surgical aortic heart valve. The valve uses a proprietary biopolymer material, dubbed LifePolymer, as well as a proprietary design, the Salt Lake City-based company said. Foldax touted that the Tria heart […]
Leviticus Cardio, Jarvik Heart unveil wireless LVAD
Jarvik Heart and Leviticus Cardio yesterday unveiled a new collaborative wirelessly-powered left ventricular assist device and touted its recent first-in-human use. An article on the new heart and its first implantation was recently published in the Journal for Heart and Lung Transplantation, the companies said. The device, dubbed the Fully Implanted Ventricular Assist Device (FIVAD), […]
Vectorious starts trial of implantable wireless heart monitor
Vectorious Medical Technologies said it has begun a first-in-human trial of its left atrial pressure monitoring device. Tel Aviv-based Vectorious is developing the V-Lap implantable wireless heart monitor, which is designed to monitor pressure in the heart’s left atrium. The Vector-HF trial will enroll up to 30 patients at six sites across Germany, Israel, Italy and the U.K. […]
Study: Procedures with Abbott’s Mitraclip show sustained low complication, mortality rates
Despite an increase in the number of procedures due to aging patients, minimally invasive mitral valve repair procedures using Abbott‘s (NYSE:ABT) Mitraclip system maintain a low mortality and complication rate, according to a new study from Mainz University Medical Center’s Center for Cardiology. Researchers in the Germany-based study examined more than 13,575 minimally invasive mitral […]
Could this device replace pacemaker batteries?
The heart’s motion is so powerful that it can recharge lifesaving cardiac devices, according to new research from Dartmouth College. Engineers at Dartmouth’s Thayer School of Engineering developed a dime-sized device to convert the heart’s kinetic energy into electricity to power a wide range of implantable devices, according to the Hanover, N.H.-based college. Get the full […]
Abbott again escapes payer’s lawsuit over St. Jude Medical CRM batteries
The Medical Device Amendment’s pre-emption clause continues to provide legal cover for medtech companies in the U.S., with Abbott getting a payer’s lawsuit dismissed over the past week. Abbott faced a purported class-action lawsuit that a third-party payer — the ASEA/AFSCME Local 52 Health Benefits Trust in Alaska — filed last year in federal court in […]