Edwards Lifesciences Corp has received approval from FDA for the transfemoral delivery of the Edwards SAPIEN transcatheter aortic heart valve for the treatment of inoperable patients with severe symptomatic aortic stenosis. According to the company, this is the first US commercial approval for a transcatheter device enabling aortic valve replacement without the need for open-heart surgery.

Transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN valve enables multidisciplinary heart teams to replace a patient's diseased aortic valve without traditional open-heart surgery and while the heart continues to beat—avoiding the need for cardiopulmonary bypass.

"This day marks an important milestone for inoperable American patients who have long been awaiting a therapeutic option for the often debilitating symptoms associated with severe aortic stenosis," says Michael A. Mussallem, Edwards' chairman and CEO. "We are extremely proud of the dedication of the heart teams and the patients involved in the clinical trial for this therapy, who have paved the way for this therapy to help even more people around the world."

In performing the TAVR procedure, the valve is crimped onto the catheter-based transfemoral delivery system, which is inserted into the body through a small cut in the leg. Once delivered to the site of the patient's diseased valve, the Edwards SAPIEN valve is expanded with a balloon and immediately functions in place of the patient's native valve.

The Edwards 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 inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis.

The safety and effectiveness of the Edwards SAPIEN transcatheter valve were evaluated in a randomized, controlled pivotal study called The PARTNER Trial. The name of the trial signifies the important partnership between cardiac surgeons and interventional cardiologists, who were brought together to collaborate in patient evaluation, treatment and follow-up. Additional analyses of data from The PARTNER Trial demonstrated that patients receiving the SAPIEN valve experienced substantially better quality of life as compared to the control group patients, and also that TAVR was cost effective.

As part of this approval, FDA has requested the implementation of two substantial postapproval studies. One study will follow patients already enrolled in The PARTNER Trial, and the second study will track new US patients. The company anticipates the second study will be incorporated into a new national patient registry.