Edwards Lifesciences: PARTNER Trial Shows Significant Benefits With Sapien Valve

(RTTNews) - Edwards Lifesciences Corp. (EW) reported the presentation of five-year clinical outcomes for inoperable patients treated in The PARTNER Trial, a randomized trial for transcatheter aortic valve replacement in patients deemed too sick for open-heart surgery. The company said the longer term results from PARTNER's inoperable cohort indicated that transcatheter aortic valve replacement was associated with a continued significant mortality benefit, persistent symptom benefit and a statistically significant reduction in rehospitalizations.

The prospective, multicenter PARTNER Trial documented the outcomes of 358 inoperable aortic stenosis patients treated at 21 centers between 2007 and 2009. In Cohort B of The PARTNER Trial, inoperable patients with severe, symptomatic aortic stenosis were evenly randomized to receive either transfemoral transcatheter aortic valve replacement with the SAPIEN valve or standard therapy, which included balloon aortic valvuloplasty or medical management of symptoms.