Category: Replacement Heart Valves
California device maker Claret Medical plans to use its new funds to complete a U.S. pivotal trial of its Sentinel cerebral protection system.
Claret Medical said today that it secured up to $18 million in Series B financing it plans to use to make progress toward the U.S. market.
Philips Healthcare wins 510(k) clearance from the FDA for its 3D planning software for transcatheter aortic valve implants.
Direct Flow Medical wins CE Mark approval in the European Union for the smallest size of its replacement heart valve and another EU nod for implanting the device without contrast media.
Direct Flow Medical said today that it won CE Mark approval in the European Union for an additional size of its replacement heart valve, plus an EU OK for the use of the devices without contrast media.
Medtronic CEO Omar Ishrak says the medical device company's CoreValve replacement heart valve has captured more than 40% of the U.S. transcatheter aortic valve implant market in just 2 quarters.
Medicare regulators agree to reimburse transcatheter mitral valve repair devices, a major win for Abbott and its market-leading MitraClip implant.
The Centers for Medicare & Medicaid Services issued a final coverage decision for transcatheter mitral valve replacement devices, a decision that currently only affects Abbott's (NYSE:ABT) MitraClip implant.
Medicare regulators finalize new reimbursement coverage for Abbott's MitraClip heart valve device and St. Jude Medical's CardioMEMs heart failure monitoring system.
A registry study of early TAVI devices finds that patients with Medtronic's CoreValve were more likely to have aortic regurgitation, but patients with Edwards Lifesciences' Sapien fared worse if they had aortic regurgitation.