Edwards Lifesciences Delays Heart Valve Trials

Edwards Lifesciences has delayed enrollment in its percutaneous aortic heart valve clinical feasibility trials in the U.S. to incorporate a new delivery system being evaluated in Canada.

The company took this voluntary action after some U.S. antegrade cases demonstrated a greater degree of clinical complexity and adverse outcomes when compared to results of a Canadian study, where cases are being performed with a new retrograde delivery system. The company said "more than one" of the 10 patients in the U.S. trial died, and others experienced serious complications.

Edwards has notified the FDA of its plans and is working to obtain approvals for this delivery approach. The company believes it will be able to resume its feasibility trial later this year.