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.