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news.Edwards Lifesciences has received conditional approval from the FDA for a revised design to the US pivotal clinical trial of the Edwards Sapien transcatheter aortic heart valve technology.
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The FDA approved the addition of the Ascendra transapical delivery system to the trial, and also granted permission to increase its trial sample size from 600 patients to 1,040 patients. 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.
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, 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.
Michael Mussallem, chairman and CEO of Edwards Lifesciences’s, said: “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. Incorporating Ascendra along with increasing the number of patients in the trial also will better ensure that the trial endpoints are successfully met.”