IRVINE, Calif., Jan. 29 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, today 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 replaceme
|SOURCE Edwards Lifesciences|
Copyright©2008 PR Newswire.
All rights reserved