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FDA Approves Transcatheter Valve for Patients with Inoperable AS

Issue: January/February 2012

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The Sapien transcatheter heart valve has been approved by the FDA for the treatment of patients with severe aortic stenosis who are ineligible for surgery. The approval makes the device the first artificial heart valve available in the United States that can replace an aortic heart valve without surgery.

The Sapien valve (Edwards Lifesciences) has not been approved in patients who can be treated by surgery, or who have congenital heart valve anomalies, masses or an infection in their hearts, or cannot tolerate anticoagulation/antiplatelet therapy, a release issued by the FDA stated.

The approval was based on results of the PARTNER trial, which showed that patients with inoperable AS treated with the transcatheter valve had significantly lower rates of death and cardiac symptoms (NYHA Class III or IV) compared with standard medical therapy, despite having a higher risk for both stroke and vascular complications.

This approval follows the FDA Circulatory System Devices Advisory Panel’s vote in July that the valve was safe (7-3), effective (9-1) and that the benefits outweighed the risks (9-1 with one abstention).

Up ahead, Edwards Lifesciences will be evaluating the Sapien valve through the national Transcatheter Valve Therapy registry, as well as conducting the PARTNER II trial to test the safety and effectiveness of its smaller Sapien XT transcatheter valve.

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 will look forward to the additional investigational work needed to bring this advance to the many patients who still won’t receive valve replacement with either surgery or a catheter valve and to bring the current-generation device into practice in the United States.

– Ted Feldman, MD
Cardiology Today Intervention Editorial Board member
Disclosure: Dr. Feldman has consulted for and received research grants from Abbott, Boston Scientific and Edwards Lifesciences.