Category: Replacement Heart ValvesSyndicate content

Heart Valves

TAVI: Edwards CEO says Sapien 3 could hit U.S. market this year

April 24, 2015 by Brad Perriello

Edwards Lifesciences CEO Michael Mussallem says the company now expects the FDA to approve its next-generation Sapien 3 replacement heart valve this year.

TAVI: Edwards CEO says Sapien 3 could hit U.S. market this year

CardiAQ Valve wins FDA nod for mitral valve trial

April 10, 2015 by Brad Perriello

CardiAQ Valve Technologies says the FDA granted investigation device exemption for an early feasibility trial of its transcatheter mitral valve implant.

CardiAQ Valve wins FDA nod for mitral valve trial

CardiAQ Valve Technologies today said it won a nod from the FDA for an early feasibility trial of its 2nd-generation transcatheter mitral valve implant.

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TAVI: Direct Flow to put its valve up against Medtronic's CoreValve

April 9, 2015 by Brad Perriello

The FDA says Direct Flow Medical can compare its transcatheter aortic valve implant with Medtronic's CoreValve in a clinical trial that's now slated to include a high-risk cohort.

FDA OKs expanded TAVI trial for Direct Flow Medical

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FDA expands indication for On-X Life's heart valve

April 3, 2015 by Mark Hollmer

On-X Life Technologies wins an expanded labeling indication from the FDA for its replacement heart valve.

FDA expands indication for On-X Life's heart valve

On-X Life Technologies said it nailed down an expanded labeling claim from the FDA for its aortic mechanical heart valve.

TAVI: FDA adds 'valve-in-valve' indication for Medtronic's CoreValve

March 30, 2015 by Brad Perriello

The FDA approves the use of Medtronic's CoreValve transcatheter aortic valve implant in so-called 'valve-in-valve' replacement procedures.

TAVI: FDA adds 'valve-in-valve' indication to Medtronic's CoreValve

TAVI: Japan approves Medtronic's CoreValve

March 30, 2015 by Brad Perriello

Regulators in Japan approve Medtronic's CoreValve transcatheter aortic valve implant.

TAVI: Japan approves Medtronic's CoreValve

Medtronic (NYSE:MDT) today said it won approval in Japan for its CoreValve replacement heart valve.

ACC 2015: Danish study finds TAVI safe for low-risk patients

March 16, 2015 by MassDevice

A Danish study presented at the American College of Cardiology's annual conference shows that transcatheter aortic valve implants are safe in low-risk patients.

ACC 2015: Danish study finds TAVI safe for low-risk patients

(Reuters) — Transcatheter aortic valve implantation is safe for low-risk patients, according to a study presented at the American College of Cardiology meeting in San Diego.

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