Edwards Lifesciences Gains 8% Following Positive Trial

Shares of Edwards Lifesciences Corp EW gained more than 8 percent early Monday morning after the company announced over the weekend results from a clinical study involving patients at intermediate risk for open-heart surgery.

Edwards Lifesciences stated its data showed that patients at intermediate risk for open-heart surgery demonstrated that transcatheter aortic valve replacement (TAVR) with its SAPIEN 3 valve was superior to surgery at one year on a composite primary endpoint of mortality, stroke and moderate or severe aortic regurgitation.

Edwards Lifesciences added that the SAPIEN 3 valve demonstrated clinical superiority at one year on individual assessments of all-cause mortality and of stroke.

The study involved 1,078 patients who were enrolled in the SAPIEN 3 study at 51 states. One-year outcomes were compared with one-year srugical outcomes in the PARTNER II randomized trial.

"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," said Vinod Thourani, M.D., co-director, Structural Heart and Valve Center of the Emory Heart and Vascular Center, chief of cardiothoracic surgery at Emory Hospital Midtown and professor of surgery, Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine. Thourani is the co-principal investigator of the SAPIEN 3 study. "The size and rigor of this 3,000-patient PARTNER II Trial provide powerful evidence in favor of this therapy for the treatment of patients with aortic stenosis."