Edwards’ Next-Generation TAVR Gets Much-Anticipated OK from FDA

Edwards Lifesciences Corp. received U.S. Food and Drug Administration (FDA) approval on June 15 for its next-generation heart valve replacement system for high-risk patients and those deemed too frail to endure open heart surgery.

The FDA approved the Sapien XT transcatheter aortic valve replacement (TAVR) system, Edwards said, adding that it will make the device immediately available to patients with severely diseased aortic valves. TAVR systems thread the replacement heart valve into place using a catheter, sparing typically elderly patients chest cracking open heart surgery and lengthy hospital stays. (For more information on the TAVR market, visit June issue of MPO magazine.)

An updated version of the original Sapien has been eagerly awaited by physicians and Wall Street. The XT uses a smaller—and, according to the company—easier to maneuver, catheter than its predecessor. The XT has been available since 2010 in Europe.
Market watchers have been waiting for the approval as an important next step in competing with Medtronic Inc.’s CoreValve, which uses a smaller catheter than the original Sapien and was approved by the FDA earlier this year, ending Edwards hold on the U.S. TAVR market.

“Over the last few months, investors have anxiously awaited the U.S. approval of Edwards’ second-generation transcatheter valve, Sapien XT,” JP Morgan analyst Michael Weinstein wrote in a research note on, questioning the long wait for approval of a system seen as an important growth driver for Edwards.

Medtronic agreed last month to pay $1 billion to Edwards to settle patent infringement litigation, to keep its CoreValve on the U.S. market.

“There is a substantial and growing body of evidence that the Sapien XT valve benefits both high-risk and inoperable patients, and clinicians have documented these consistently positive results in both randomized studies and European country registries,” said Martin B. Leon, M.D., director, Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Medical Center and professor of medicine at the Columbia University College of Physicians and Surgeons. Dr. Leon was the co-principal investigator for the Partner II Trial, which was Edwards’ second randomized controlled trial of a transcatheter valve and evaluated the Sapien XT valve. “The results from the PARTNER II Trial in treating U.S. inoperable patients with the Sapien XT valve demonstrated a reduction in complications with the TAVR procedure, and improved patient outcomes over earlier trials.”

“Clinicians have demonstrated their confidence in the Sapien valves by making them the market-leading transcatheter valves, and this approval provides greater options for U.S. patients who can benefit from the substantial enhancements in this proven platform,” said Larry L. Wood, Edwards’ corporate vice president, transcatheter heart valves. “The Sapien family of valves has been used in the treatment of more than 70,000 patients globally—with the majority of those patients treated with Sapien XT—and we look forward to Heart Teams across America transforming the lives of even more patients with this advanced transcatheter valve.”