Edwards Lifesciences wins CE Mark for Centera TAVR

Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its self-expanding transcatheter Centera aortic heart valve, with indications for treating symptomatic aortic stenosis patients at high risk of open-heart surgery.

The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Irvine, Calif.-based company said.

“With the Edwards Centera valve, European clinicians and their patients may now benefit from a self-expanding TAVR option that has demonstrated exceptional clinical safety and performance outcomes in the high surgical risk population. Enhanced design features of the Centera valve, including a motorized handle that enables stable valve deployment, allow for a simpler procedure with compelling outcomes,” Dr. Didier Tchétché of Toulouse, France’s Clinique Pasteur said in a prepared statement.

The certification was based off data from the 203-patient Centera-EU trial, which reported a 99% survival rate, 2.5% rate of disabling stroke and a 4.9% rate of new permanent pacemaker placement at 30 days. Results also indicated a 0.6% rate of paravalvular leak and no incidents of severe paravalvular leak.

“Edwards is committed to partnering with clinicians to offer differentiated, best-in-class technologies for transcatheter heart valve therapy. European certification of the Centera valve provides a meaningful treatment option for high-risk TAVR patients when their heart team recommends a self-expanding device,” Edwards transcath heart valves corporate VP Larry Wood said in a press release.

Earlier this month, Edwards saw shares rise after the medical device maker beat expectations on Wall Street with its fourth quarter and full fiscal 2017 earnings results.

The post Edwards Lifesciences wins CE Mark for Centera TAVR appeared first on MassDevice.

from MassDevice http://ift.tt/2BvxTDe