TAVI Archives - MassDevice

Biotronik today said its entry into a hot replacement heart valve market passed the safety endpoint of a 1st-in-human trial.

The German medical device giant said the Biovalve trial of its transcatheter aortic valve implant established the device’s early safety at 30 days.

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.

Edwards CEO Mussallem hopes FDA to accelerate approvals of medical devices

Edwards CEO talks innovation and regulation on Capitol Hill

(Reuters) – U.S. health regulators appear open to speeding up approvals of medical devices that currently often reach European markets three to five years ahead of being cleared in the United States, the chief executive officer of EW) said.