Edwards Lifesciences Corporation announced that it will be completing the study of Edwards SAPIEN XT valve by February 2015.
Edwards SAPIEN XT valve with its improved design and novel lower profile delivery system, will allow treating aortic stenosis patients more reliably and safely. This transcatheter valve has a cobalt chromium alloy balloon-expandable frame, which allows for a significant reduction in its profile, and bovine pericardial tissue leaflets processed in the same stringently controlled manner as other surgical heart valves. SAPIEN XT valve are intended to make transcatheter valve therapy accessible to even more patients.
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT transcatheter heart valve (model 9300TFX; study valve), RetroFlex 3 transfemoral delivery system, and crimper accessories. The trial includes a premarket confirmatory cohort to evaluate the system performance as well as a Post Market Clinical Follow-up phase involving expanded enrollment and long-term follow-up of all patients to evaluate valve performance out to 5 years.
This 150 patient study is currently recruiting participants. The official title of the study is “PREVAIL EU Transfemoral Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (EUROPE)”.