FDAnews Device Daily Bulletin

Edwards Lifesciences has received conditional approval from the FDA for a revised design to the U.S. trial of the Edwards SAPIEN transcatheter aortic heart valve technology.

The agency approved the addition of the Ascendra transapical delivery system to the trial and also allowed Edwards to increase its trial sample size from 600 to 1,040 patients, the company said.

The PARTNER trial began in the second quarter of 2007 and is evaluating the valve in patients who are considered high risk or inoperable for conventional open-heart valve surgery.