Edwards Sapien 3 TAVR Device Receives Intermediate-Risk Indication in Europe
September 19, 2016—Edwards Lifesciences Corporation announced that it has received CE Mark approval to expand use of the Sapien 3 transcatheter aortic valve replacement (TAVR) device for the treatment of patients with severe, symptomatic aortic stenosis who are at intermediate risk for open heart surgery.
The Sapien 3 was first approved in Europe in January 2014 for the treatment of patients with severe, symptomatic aortic stenosis who are at high risk for open heart surgery. On August 18, Edwards Lifesciences announced that the US Food and Drug Administration approved the expanded indication for the Sapien 3 valve to treat intermediate-risk patients in the United States.
In the company’s announcement, Prof. Helge Möllmann, MD, commented, “This expanded intermediate-risk indication allows for the treatment of even more patients whose only previous option was an open heart surgical procedure. I am encouraged by the adoption of the position paper of the German Cardiac Society that recommends the use of TAVR in intermediate-risk patients based on growing clinical evidence.” Prof. Möllmann is Director, Clinic for Internal Medicine (Cardiology) at St. Johannes Hospital in Dortmund, Germany.
According to Edwards, for patients with severe aortic stenosis who are at intermediate risk for an open heart surgical procedure, TAVR using the Sapien 3 valve has been shown to demonstrate superior outcomes compared with surgery at 1 year on a composite primary endpoint of mortality, stroke, and moderate or severe aortic regurgitation.
As reported in April 2016, findings from the PARTNER II trial assessing long-term outcomes of TAVR with the Sapien 3 valve in intermediate-risk patients versus surgical aortic valve replacement were presented by Prof. Vinod Thourani, MD, at ACC.16, the American College of Cardiology’s 65th annual scientific session in Chicago, Illinois. The study was published simultaneously online by Prof. Thourani, et al in The Lancet (2016;387:2218–2225). In The Lancet, the investigators concluded, "TAVR with Sapien 3 in intermediate-risk patients with severe aortic stenosis is associated with low mortality, strokes, and regurgitation at 1 year. The propensity score analysis indicates a significant superiority for our composite outcome with TAVR compared with surgery, suggesting that TAVR might be the preferred treatment alternative in intermediate-risk patients."