Category: Cardiac Implants
Boston Scientific's novel lead-free implantable cardioverter defibrillator makes an introduction in the Asia Pacific region.
Massachusetts medical device giant Boston Scientific (NYSE:BSX) is taking its S-ICD lead-free cardiac implant on tour, reaching new regions in Asia Pacific.
ReliantHeart touts study data finding that its HeartAssist5 left ventricular assist device poses a lower risk of blood clots and damage compared with Thoratec's HeartMate II.
FDA regulators put their highest-risk Class I label on a recall of Thoratec's HeartMate II implantable heart pump after 5 patients injuries and 4 deaths were reportedly associated with a defect in controlling the implants.
MASSDEVICE ON CALL — The FDA issued it's highest-risk Class I warning after Thoratec (NSDQ:THOR) recalled its HeartMate II implantable heart pumps over a controller issue that the FDA said was associated 4 patient deaths and 5 serious injuries.
Transcatheter Technologies' touts zero instances of paravalvular leakage in 6-month pilot results for its Trinity transcatheter aortic valve implantation system.
Transcatheter Technologies GmbH touted 6-month results from a pilot study of its Trinity transcatheter aortic valve implantation system, reporting no instances of valve leakage.
The Reveal LINQ insertable cardiac monitor is now available in the U.S. and European Union member countries after landing regulatory clearance from regulators in both regions.
Medtronic (NYSE:MDT) landed both CE Mark approval in Europe and FDA 510(k) clearance in the U.S. for its Reveal LINQ insertable cardiac monitor.
Transcatheter Technologies completes durability testing on its Trinity 3rd-generation transcatheter aortic valve implantation system, after putting the device through an estimated 15 years' worth of cycles.
German device maker Transcatheter Technologies GmbH said it finished durability-testing Trinity transcatheter aortic valve implantation system.
The company expects Trinity to be "the world's 1st 'truly repositionable'" replacement aortic valve. The device was put through 600 million cycles, or around 15 years, of durability testing by an independent lab, which reported that the device far exceeded minimum standards, according to a press release.