FDAnews Device Daily Bulletin


Dec. 2, 2005

Edwards Lifesciences has received conditional approval from the FDA to enroll 20 patients in a non-randomized feasibility trial of its Cribier-Edwards percutaneous aortic heart valve -- a decision that comes roughly six months after the firm suspended the original trial.

The trial, which will take place at three clinical sites, will include a new retrograde delivery system and an additional, larger sized, 26-mm replacement heart valve, the firm said.

The advanced retrograde delivery system provides a simpler route for introducing the valve non-surgically, threading it through the patient's circulatory system from the leg directly to their aortic valve, Edwards said. Cases are expected to resume upon investigational review board approval and the completion of clinician training with the new delivery system.

Edwards enacted a voluntary suspension of its percutaneous aortic heart valve trial in June after serious complications with participants lead to the death of at least one patient.

"We are eager to resume this important trial, and are looking forward to treating the many patients who have been referred and qualify for this investigation," said William O'Neill, chief of cardiology at William Beaumont Hospital in Royal Oak, Mich., the study's principal investigator.

Upon successful completion of the feasibility study, Edwards said it will work closely with the FDA to determine next steps in support of U.S. approval. In Europe, where a multicenter CE mark study has been initiated, the new retrograde system and larger valve are being introduced on a site-by-site basis, the firm said.