Category: Cardiac Implants
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.
St. Jude Medical implants the 1st U.S. patient with its Nanostim leadless pacemaker, which is implanted directly in the heart.
St. Jude Medical (NYSE:STJ) today touted the 1st U.S. implant of its Nanostim pacemaker, a leadless device implanted directly into the heart to help regulate abnormal heart rhythms.
Massachusetts-based Abiomed reports record Impella heart pump revenues during its 3rd quarter, with sales up 20% year-over-year.
Bay state medical device maker Abiomed (NSDQ:ABMD) reported another strong quarter, with revenues up 20% on record sales of its flagship Impella cardiac pump.
St. Jude Medical implants the 1st U.K. patient with its Nanostim pacemaker, the 1st heart rhythm moderating device of its kind implanted directly in the heart.
Corrected January 28, 2014, 11:45 a.m.
Carmat successfully implants the 1st human patient with its bioprosthetic artificial heart.
Paris-based medical device maker Carmat this month successfully implanted its 1st bioprosthetic artificial heart, according to a company statement.
The company conducted the implant as part of a feasibility study, in accord with approval studies with the French health authority, the ANSM.