September 19, 2016 — Edwards Lifesciences received European CE mark to expand use of the Edwards Sapien 3 transcatheter heart valve for the treatment of patients suffering from severe, symptomatic aortic stenosis who are at intermediate risk for open-heart surgery.
"This expanded intermediate-risk indication allows for the treatment of even more patients whose only previous option was an open-heart surgical procedure," said Prof. Helge Möllmann, director, Clinic for Internal Medicine (Cardiology) at St. Johannes Hospital, Dortmund, Germany. "I am encouraged by the adoption of the position paper of the German Cardiac Society that recommends the use of transcatheter aortic valve implantation (TAVI) in intermediate-risk patients based on growing clinical evidence."
For patients with severe aortic stenosis who are at intermediate risk for an open-heart surgical procedure, TAVI using the Sapien 3 valve has been shown1 to demonstrate outcomes that are superior to surgery at one year on a composite primary endpoint of mortality, stroke and moderate or severe aortic regurgitation.
The valve 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. The U.S. Food and Drug Administration approved the Sapien 3 valve for the treatment of intermediate-risk patients in August 2016. Read the article “FDA Expands Sapien TAVR Valve Indication to Intermediate-Risk Patients.”
Watch a video “TAVR Beats Surgery — Top News From ACC.16.” Dr. Thourani discusses the biggest news item from ACC.16 — the Sapien 3 TAVR device performed better that surgical aortic valve replacement.
For more information: www.Edwards.com
Reference:
1. Thourani V et al. "Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis." The Lancet 2016;1-8.
November 14, 2025 
