Edwards' Self-Expanding Transcatheter Heart Valve Receives CE Mark

IRVINE, Calif., Edwards Lifesciences Corporation, the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced it has received CE Mark for its self-expanding CENTERA valve for severe, symptomatic aortic stenosis patients at high risk of open-heart surgery. The Edwards CENTERA valve is repositionable and retrievable and can be delivered through a low-profile, 14-French, motorized delivery system. It is uniquely packaged with the valve fully pre-attached to the delivery system, which facilitates simple and rapid device preparation.

"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," said Didier Tchétché, M.D., of Clinique Pasteur in Toulouse, France. "Enhanced design features of the CENTERA valve, including a motorized handle that enables stable valve deployment, allow for a simpler procedure with compelling outcomes."

European certification of the CENTERA valve was based on the CENTERA-EU Trial, which enrolled 203 high-risk patients at 23 centers in Europe, Australia and New Zealand. Study results presented at EuroPCR 2017 demonstrated high survival rates (99 percent) and low rates of disabling stroke (2.5 percent) and new permanent pacemaker (4.9 percent) 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.

"Edwards is committed to partnering with clinicians to offer differentiated, best-in-class technologies for transcatheter heart valve therapy," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves. "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 U.S.