Category: Replacement Heart Valves
Edwards Lifesciences CEO Michael Mussallem says the company now expects the FDA to approve its next-generation Sapien 3 replacement heart valve this year.
CardiAQ Valve Technologies says the FDA granted investigation device exemption for an early feasibility trial of its transcatheter mitral valve implant.
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.
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.
On-X Life Technologies wins an expanded labeling indication from the FDA for its replacement heart valve.
On-X Life Technologies said it nailed down an expanded labeling claim from the FDA for its aortic mechanical heart valve.
The FDA approves the use of Medtronic's CoreValve transcatheter aortic valve implant in so-called 'valve-in-valve' replacement procedures.
Regulators in Japan approve Medtronic's CoreValve transcatheter aortic valve implant.
Medtronic (NYSE:MDT) today said it won approval in Japan for its CoreValve replacement heart valve.
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.
(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.