FDA Approves New Use for Edwards Lifesciences Heart Valve

Step by step, Edwards Lifesciences has been broadening the scope for its Sapien transcatheter aortic heart valve, which is derived from bovine biologic material. In June, a U.S. Food and Drug Administration (FDA) panel recommended the valve be considered an alternative to open-heart surgery. The FDA has now approved the device to treat high-risk aortic stenosis patients with the Edwards SAPIEN transcatheter aortic heart valve delivered both transfemorally (via the leg) and transapically (through the ribs). The device is designed to treat aortic stenosis, which is caused by a narrowing valve that restricts the ability of blood to enter the aorta, the main artery that carries blood from the heart. The approval from the FDA, received in late October, allows for the treatment of more high-risk patients. Previously, Sapien was approved in the United States only for the treatment of inoperable patients via the transfemoral approach (FDA approval was granted on Nov. 2, 2011), but the addition of the transcapical approach broadens the group of treatable patients.

“We are thankful to the multidisciplinary heart teams who worked diligently throughout The Partner Trial to bring new treatments to U.S. patients at high risk for surgical aortic valve replacement,” said Larry L. Wood, Edwards’ corporate vice president, transcatheter heart valves. “It is extremely rewarding for us and our clinical partners to know that high-risk patients suffering from this often debilitating disease will now have access to this life-saving therapy.”

In performing the transcatheter aortic valve replacement (TAVR) procedure, the valve is crimped onto the catheter-based delivery system and inserted into the body either transfemorally or now, transapically. Once delivered to the site of the patient’s diseased valve, the Sapien valve is expanded with a balloon and immediately functions in place of the patient’s native aortic valve, claims Edwards Lifesciences.

The Sapien valve is indicated for the treatment of patients with severe symptomatic calcified native aortic valve stenosis who have been examined by a heart team, including an experienced cardiac surgeon and a cardiologist, and found to be inoperable or at high risk for traditional open heart surgery, and in whom existing co-morbidities would not preclude the expected benefit from the procedure.

The safety and effectiveness of the Sapien valve were evaluated in a randomized, controlled pivotal study called The Partner Trial. Edwards Lifesciences submitted a premarket application to the FDA in April 2011 based on data from the high-risk cohort (Cohort A) of The Partner Trial. Cohort A compared the outcomes of patients at high risk for traditional open-heart surgery randomized to receive either surgical aortic valve replacement or the Sapien valve via transfemoral or transapical delivery. The trial was successful in meeting its primary endpoint at one year, concluding that survival of high-risk patients treated with the Sapien valve was equivalent to those treated with traditional open-heart surgery.

Cohort B’s results were just announced on Oct. 24. The clinical study of inoperable patients with severe aortic stenosis showed a sustained and increasing survival benefit for Sapien valve patients after three years. The death rate after three years (from any cause) for TAVR patients was 54 percent, compared to 81 percent for patients receiving standard therapy. However, there was a higher stroke rate in the transcatheter group as compared to standard therapy. This was judged to not be related to the procedure or device, according to Edwards Lifesciences.

“We are very pleased that the inoperable patients in The Partner Trial continued to experience benefits in all the key measures of clinical outcomes,” said Michael A. Mussallem, Edwards’ chairman and CEO. “The performance and durability of the Edwards Sapien valve also remained excellent. The three-year data further highlight the devastating effects of symptomatic severe aortic stenosis in patients receiving only standard therapy—reinforcing the important role that transcatheter valve replacement plays in the treatment of these patients.”

Based in Irvine, Calif., Edwards Lifesciences is focused on heart valves and hemodynamic monitoring technology.