FDA OKs Adding Transapical Delivery System to Transcatheter Heart Valve Trial
January 29, 2008 - Edwards Lifesciences Corp. received conditional approval from the FDA for the addition of the Ascendra transapical delivery system to the U.S. pivotal clinical trial of the Edwards SAPIEN transcatheter aortic heart valve technology.
The FDA also granted permission to Edwards to increase its trial sample size from 600 patients to 1,040 patients. These approvals enable Edwards to address a larger population of patients who may have few or no options for treatment of their heart valve disease.
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.
With these trial revisions, patients with symptomatic, calcific aortic stenosis will be evaluated for inclusion in one of two separate treatment arms, surgical or medical management.
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.
For more information: www.edwards.com