Edwards Lifesciences Corp (NYSE:EW) shares gained more than 15% gained Monday morning following after the anticipated results of a clinical trial involving patients at intermediate risk for open-heart surgery, and testing the SAPIEN 3 Transcatheter Heart Valve.
The data released by Edwards Lifesciences indicates that patients who are at risk for open heart surgery showed that trans catheter aortic valve replacement with EW’s SAPIEN 3 valve was a better alternative to surgery at one year on a composite primary endpoint of mortality, stroke and moderate or severe aortic regurgitation. The company has also showed that the SAPIEN 3 valve demonstrated clinical superiority at one year on individual assessments of all-cause mortality and of stroke.
The clinical trial had 1,078 patients involved, and one year outcomes of patients who had the valve were compared with one-year srugical outcomes.
Vinod Thourani, M.D., co-director, Structural Heart and Valve Center of the Emory Heart and Vascular Center, said, "Results from the PARTNER II Trial presented at ACC should establish the SAPIEN 3 valve as the new benchmark for the treatment of intermediate-risk patients with severe, symptomatic aortic stenosis,"
Shares of Edwards Lifesciences increased in value by more than 200% in two years.