Edwards Lifesciences has received the CE mark for its self-expanding Centera transcatheter aortic valve implantation (TAVI) valve for severe, symptomatic aortic stenosis patients at high risk of open-heart surgery.
A press release reports that the valve is repositionable and retrievable and can be delivered through a low profile, 14Fr, motorised delivery system. The press release adds that the advice is uniquely packaged with the valve fully pre-attached to the delivery system, which facilitates simple and rapid device preparation.
The European certification of the Centera valve was based on the CENTERA-EU trial, which enrolled 203 high-risk patients at 23 centres in Europe, Australia and New Zealand. Study results presented at EuroPCR 2017 demonstrated high survival rates (99%) and low rates of disabling stroke (2.5%) and new permanent pacemaker (4.9%) at 30 days. In addition, there was a low 0.6 percent rate of moderate paravalvular leak among patients, and zero incidents of severe paravalvular leak. All patients in the study were treated via the transfemoral access route with the majority under conscious sedation.
Didier Tchétché (Clinique Pasteur in Toulouse, France) comments: “With the Edwards Centera valve, European clinicians and their patients may now benefit from a self-expanding TAVI 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 motorised handle that enables stable valve deployment, allow for a simpler procedure with compelling outcomes.”
Larry L Wood, Edwards’ corporate vice president, transcatheter heart valves, comments: “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 CENTERA valve is not approved for commercial sale in the USA.