Edwards Lifesciences has received conditional approval from the FDA for a revised design to the U.S. clinical trial of its Sapien transcatheter aortic heart valve technology.
In the clearance, the FDA approved the addition of the Ascendra transapical delivery system to the trial, and also granted Edwards permission to increase its trial sample size from 600 patients to 1,040 patients, according to the Irvine, Calif.-based Edwards.
The Placement of AoRTic traNscathetER valves (PARTNER) trial, initiated in the second quarter of 2007, is evaluating the Edwards’ Sapien valve in patients who are considered high risk or inoperable for conventional open-heart valve surgery.
Edwards said the surgical arm of the trial evaluates its Sapien valve and the two transcatheter delivery systems — Ascendra for transapical access, and RetroFlex for transfemoral access — as compared to surgical, open-heart valve replacement. The medical management arm of the trial evaluates the Sapien valve with the RetroFlex transfemoral delivery system as compared to appropriate medical therapy, according to the company.
The Sapien valve with the Ascendra transapical and RetroFlex transfemoral delivery systems is commercially available in Europe.