Irvine, California-based Edwards says the regulatory nod makes it the first transcatheter valve replacement therapy to receive approval to treat tricuspid regurgitation (TR).
Evoque features a nitinol self-expanding frame and an intra-annular sealing skirt. It makes the device’s tissue leaflets from the same bovine pericardial tissue used for Edwards’ other leading heart valves. The company plans to offer Evoque in three sizes, all delivered through a low-profile, transfemoral 28F system.
“Innovating for unmet patient needs is at the center of everything we do at Edwards, which makes us especially proud to have received CE Mark for this first-of-its-kind transcatheter tricuspid valve replacement therapy,” said Daveen Chopra, Edwards VP, transcatheter mitral and tricuspid therapies. “With the Evoque system’s approval, in addition to our current Pascal tricuspid system, we are now able to provide a broader array of much-needed treatment options for appropriate tricuspid disease patients in Europe.”
Results from the TRISCEND study of Evoque supported the approval. TRISCEND, presented last year, demonstrated favorable safety, efficacy and quality-of-life outcomes.
One-year outcomes demonstrated high survival of 90.1% and high freedom from heart failure hospitalization at 88.4%. Additionally, subjects showed significant and sustained TR reduction with 97.6% of patients demonstrating mild or trace TR.
Edwards plans to present results from its TRISCEND II pivotal trial next week as well. Evoque remains investigational for TR in the U.S.
The company’s European approval follows some scrutiny on that continent around some of its heart implant devices. A report this week said European officials probed Edwards Lifesciences over potential antitrust activity because of patent practices.
