Category: Replacement Heart ValvesSyndicate content

Heart Valves

Claret Medical chases FDA win with $18M Series B for cerebral protection device

August 21, 2014 by Arezu Sarvestani

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 chases FDA win with up to $18M raised in Series B

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 wins FDA nod for 3D TAVI planning software

August 21, 2014 by Brad Perriello

Philips Healthcare wins 510(k) clearance from the FDA for its 3D planning software for transcatheter aortic valve implants.

Philips wins FDA nod for 3D TAVI planning software

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Direct Flow wins CE Marks for TAVI device

August 21, 2014 by Brad Perriello

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 wins CE Marks for TAVI device

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.

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Medtronic claims a 40% share of U.S. TAVI market with CoreValve

August 20, 2014 by Brad Perriello

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.

Medtronic claims a 40% share of U.S. TAVI market with CoreValve

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Medicare finalizes coverage for MitraClip

August 11, 2014 by Arezu Sarvestani

Medicare regulators agree to reimburse transcatheter mitral valve repair devices, a major win for Abbott and its market-leading MitraClip implant.

Medicare finalizes coverage for MitraClip

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.

Abbott's MitraClip, St. Jude's CardioMEMS land new Medicare coverage

August 6, 2014 by Arezu Sarvestani

Medicare regulators finalize new reimbursement coverage for Abbott's MitraClip heart valve device and St. Jude Medical's CardioMEMs heart failure monitoring system.

Abbott's MitraClip, St. Jude's CardioMEMS land new Medicare coverage

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TAVI study: Sapien tops CoreValve in AR risk, but is CoreValve safer?

August 4, 2014 by Arezu Sarvestani

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.

TAVI study: Sapien tops CoreValve in AR risk, but is CoreValve safer?
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