Edwards Lifesciences has received approval from the FDA for the transfemoral delivery of the Edwards Sapien transcatheter aortic heart valve for the treatment of inoperable patients with severe symptomatic aortic stenosis. This is the first US commercial approval for a transcatheter device enabling aortic valve replacement without the need for open-heart surgery.
“Surgery to replace the aortic valve is an effective treatment for severe senile aortic valve stenosis. The Sapien transcatheter heart valve (Edward Lifesciences) is an example of an innovative new device that will provide some people with this condition who cannot undergo open heart surgery with the option of valve replacement,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “The agency remains committed to working with companies who are developing breakthrough treatments that will have a significant impact on patient care in the USA.”
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 randomised, 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.
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 one year after surgery. After a year, 69% of the Sapien patients were alive compared with 50% of those who received an alternative treatment.
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 TAVI was cost effective.
As part of this approval, FDA has requested the implementation of two substantial post-approval 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.
The Sapien transcatheter valve is made of cow tissue and polyester supported with a stainless steel mesh frame. To replace the diseased valve, the Sapien valve is compressed into the end of a long, thin, tube-like device called a delivery catheter. The delivery catheter, which is slightly wider than a pencil, and the Sapien valve are inserted into the femoral artery and threaded to the site of the diseased valve. The heart valve is then released from the delivery catheter and expanded with a balloon and is immediately functional.
The product label advises that a heart surgeon should be involved in determining if the Sapien valve is an appropriate treatment for the patient. The device is not approved for patients who can be treated by 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 valve, the FDA said.
“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,” said 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.”