Edwards To Add Transapical Delivery System To Clinical Trial Of Transcatheter Heart Valve
Transcatheter Heart Valve
Edwards Lifesciences has received conditional approval from FDA for a revised design to US 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.