FDA Approves Edwards Sapien Transcatheter Aortic Valve

November 2, 2011—Edwards Lifesciences (Irvine, CA) announced that it has received approval from the US Food and Drug Administration (FDA) for transfemoral delivery of the Edwards Sapien transcatheter aortic heart valve to treat inoperable patients who have severe symptomatic aortic stenosis. The company noted that this is the first commercial approval in the United States for a transcatheter device enabling aortic valve replacement without the need for open heart surgery.

Edwards advised that the Sapien valve is indicated for transfemoral delivery in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be unsuitable for open aortic valve replacement and in whom existing comorbidities would not preclude the expected benefit from correction of the aortic stenosis.

According to Edwards, the device's safety and effectiveness were evaluated in the randomized, controlled PARTNER pivotal study. The company noted that the trial brought together cardiac surgeons and interventional cardiologists to collaborate on patient evaluation, treatment, and follow-up. Additional analyses of PARTNER data demonstrated that patients receiving the Sapien valve experienced substantially better quality of life compared to the control group patients. PARTNER also demonstrated  that transcatheter aortic valve replacement was cost effective. Cardiac Interventions Today reported in June 2011 that the PARTNER investigators published the pivotal study's cohort A results in the The New England Journal of Medicine (2011;364:2187–2198). In September 2010, as reported in Cardiac Interventions Today, the cohort B data was published in The New England Journal of Medicine (2010;363:1597–1607).

The company stated that as part of the approval, the FDA has requested the implementation of two substantial postapproval studies. One study will follow patients who are already enrolled in the PARTNER trial, and the second study will track new patients in the United States. The company anticipates that the second study will be incorporated into a new national patient registry.

The FDA advised that through the national Transcatheter Valve Therapy registry, Edwards Lifesciences will continue to evaluate outcomes with the Sapien device. The agency noted that the Society of Thoracic Surgeons and the American College of Cardiology have been working with the FDA and the Centers for Medicare & Medicaid Services to facilitate the creation of the registry, which will serve as a platform for continued evaluation of the postmarket experience with this and future transcatheter devices and procedures for the treatment of aortic stenosis.

Cardiac Interventions Today's Chief Medical Editor Ted E. Feldman, MD, commented, “This represents a landmark in interventional cardiology and, more broadly, in cardiology and medicine. At the same time, the approval is for the inoperable segment of the population and is for the first-generation percutaneous aortic valve device. I look forward to the additional investigational work needed to treat many of the patients who still will not receive valve placement with either surgery or a catheter valve and to bring the current-generation device into practice in the United States.”

In announcing the approval, the FDA specified that the Sapien transcatheter heart valve is approved for patients who are not eligible for open heart surgery for replacement of their aortic valve and have a calcified aortic annulus. Also, the product label advises that a heart surgeon should be involved in determining whether the Sapien valve is an appropriate treatment for the patient. The device is not approved for patients who can be treated with open heart surgery. Patients who have congenital heart valve anomalies, have masses or an infection in their hearts, or cannot tolerate anticoagulation/antiplatelet therapy should not receive the Sapien transcatheter heart valve, advised the FDA.

“Surgery to replace the aortic valve is an effective treatment for severe senile aortic valve stenosis,” stated Jeffrey Shuren, MD, Director of the FDA's Center for Devices and Radiological Health. “The Sapien transcatheter heart valve is an example of an innovative new device that will provide some people with this condition who can't undergo open heart surgery with the option of valve replacement. The agency remains committed to working with companies who are developing breakthrough treatments that will have a significant impact on patient care in the United States.”

According to the FDA, the Sapien transcatheter aortic valve is composed of bovine tissue and polyester supported with a stainless steel mesh frame, which is compressed into a catheter for transfemoral delivery to the site of the diseased valve. The Sapien valve is then released from the delivery catheter and expanded with a balloon and is immediately functional.

The FDA advised that its approval of the Sapien transcatheter heart valve is based on a study in 365 patients who were not eligible for open heart surgery. Half of the patients received the Sapien valve. The other study patients received another treatment that did not require open heart surgery. One alternative procedure involved balloon valvuloplasty. Patients receiving the Sapien valve experienced two and a half times more strokes and eight times as many vascular and bleeding complications than patients who did not receive the implant; however, they were more likely to survive 1 year after surgery. After 1 year, 69% of the Sapien patients were alive compared with 50% of those who received an alternative treatment, reported the FDA.