The FDA has conditionally approved the first of two planned U.S. cohorts of the randomized, controlled PARTNER II trial, which will evaluate the next-generation Sapien XT transcatheter aortic valve from Edwards Lifesciences.
The lower profile Sapien XT valve can be delivered through an 18F sheath requiring a 6-mm iliac vessel. The first-generation Sapien valve required a 22F or 24F sheath and a minimum diameter of 7 mm and 8 mm for the 23 mm and 26 mm valves, respectively.
Along with the NovaFlex transfemoral delivery system, the lower profile valve broadens the number of eligible patients, according to the company.
The first cohort of PARTNER II will study up to 450 patients with severe, symptomatic aortic stenosis using two-to-one randomization: two Sapien XT delivered tranfemorally versus one standard therapy. The primary endpoint of the trial is a composite of death, major stroke and repeat hospitalization, with secondary endpoints that include valve performance and quality-of-life indicators.
Edwards anticipates a second patient cohort for the trial to compare traditional open-heart surgery with the Sapien XT valve delivered either transfemorally or transapically.
While the Sapien XT is not yet comercially available in the U.S., it received a CE mark for sale in Europe in March.