FDA News

FDA Okays Edwards Lifesciences to Add Transapical Delivery System to U.S. Clinical Trial of Transcatheter Heart Valve

(Jan 28, 2008)-- Edwards Lifesciences Corporation announced that it has received conditional approval from the U.S. Food and Drug Administration (FDA) for a revised design to the U.S. pivotal clinical trial of the Edwards SAPIEN transcatheter aortic heart valve technology. The FDA approved the addition of the Ascendra transapical delivery system to the trial, and also granted permission to Edwards to increase its trial sample size from 600 patients to 1,040 patients.

The PARTNER (Placement of AoRTic traNscathetER valves) 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.

"The addition of the Ascendra transapical delivery system to the PARTNER trial will enable Edwards to address a larger population of patients who may have few or no options for treatment of their heart valve disease," said Michael A. Mussallem, Edwards Lifesciences' chairman and CEO. "Incorporating Ascendra along with increasing the number of patients in the trial also will better ensure that the trial endpoints are successfully met."

With these trial revisions, patients with symptomatic, calcific aortic stenosis -- a narrowing of the aortic valve that reduces the outward flow of oxygenated blood -- will be evaluated for inclusion in one of two separate treatment arms, surgical or medical management. "The addition of the transapical approach to the PARTNER trial is an important milestone for cardiac surgeons and their patients. The transapical approach greatly expands the options for patients who need aortic valve replacement, but face excessive risk with alternative approaches," said Craig Smith, M.D., Chief of the Division of Cardiothoracic Surgery at New York-Presbyterian Hospital/Columbia University Medical Center and the co-principal investigator for the U.S. PARTNER trial.

The surgical arm of the trial evaluates the Edwards 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 Edwards SAPIEN valve with the RetroFlex transfemoral delivery system as compared to appropriate medical therapy.

Edwards has significant experience with transcatheter valve procedures based on more than 600 implants of the transcatheter heart valve through a series of extensive clinical trials and feasibility studies in Europe, the U.S. and Canada. The Edwards SAPIEN valve with the Ascendra transapical and RetroFlex transfemoral delivery systems is commercially available in Europe.

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