US-based medical equipment firm Edwards Lifesciences has secured the European CE-Mark for the use of its self-expanding heart valve, Centera, in severe, symptomatic aortic stenosis patients who are at high risk of open-heart surgery.
Designed as a repositionable and retrievable device, Centera comes pre-attached to a 14-French, motorised delivery system.
The transcatheter aortic valve replacement (TAVR) option is intended to allow stable deployment and simplified approach.
Edwards Lifesciences transcatheter heart valves corporate vice-president Larry Wood said: “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.”
The European clearance is based on the data obtained from the multi-centre Centera-EU clinical trial performed in 203 high-risk patients at 23 sites across Europe, Australia, and New Zealand.
When treated through the transfemoral access route, the self-expanding valve was reported to have led to high survival rates of 99%, low rates of 2.5% disabling stroke, and 4.9% permanent pacemaker rate at 30 days.
In addition, there was a low rate (around 0.6%) of moderate and no incidents of severe paravalvular leak. All the subjects in the trial were followed for a period of five years.
Edwards Lifesciences consultant Didier Tchétché 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.”