Edwards to Start Percutaneous Heart Valve Clinical Trial in U.S.

Edwards Lifesciences has received conditional approval from the FDA to begin the first feasibility trial of its Cribier-Edwards percutaneous aortic heart valve.

Edwards will conduct an initial feasibility study at a single U.S. center involving a randomized, controlled clinical trial of 20 patients who are at a defined level of high risk for conventional heart valve surgery. Upon successful completion of this study, Edwards will initiate a second feasibility trial, which would enroll an additional 40 patients at a limited number of sites.

The Cribier-Edwards percutaneous aortic heart valve is a proprietary technology designed to treat patients with severe aortic heart valve stenosis -- a narrowing of the valve that restricts blood flow -- who are not good candidates for conventional open-heart valve replacement surgery. The device integrates balloon-expandable stent technology with a replacement tissue heart valve that is compressed onto the balloon to the approximate diameter of a pen.