Edwards Lifesciences’ original Sapien (left) and new Sapien XT (right) valves.
Edwards Lifesciences (NYSE:EW) released new 1-year results from its European post-approval study of the next-generation Sapien XT transcatheter aortic valve implantation system, demonstrating that the device continues to perform well.
The data comprises outcomes from more than 2,600 patients enrolled from 93 centers in Europe, representing real-world cases and more than 20% of the total patients treated with Sapien XT during the course of the study, according to a press release.
"We are very pleased that studies across geographies and in both real-world and clinical trial settings continue to support the benefits to patients of the lower-profile Sapien XT valve," Edwards TAVI corporate vice president Larry Wood said in prepared remarks. "This report from the SOURCE XT Registry confirms the positive impact TAVR provides for patients’ quality of life and heart function, which is once again profound."
Despite the high risk-level of patients enrolled in the registry, 1-year survival following TAVI treatment was 80.5% and the stroke rate was 6.3%. Nearly 94% of patients were free from paravalvular leakage or reported mild leakage, according to a press release.
The latest data provides continuing support for the Sapien XT valve, which features material changes to the stent frame, the valve leaflet and the catheter that aim to make the device thinner and smaller than the original Sapien valve.
EW shares were down 2.2% to $64.55 as of about 2:30 p.m. today.
