Following last month’s FDA approval for the expanded indication of Sapien 3 for the treatment of intermediate-risk patients with aortic stenosis, the device can now be used for intermediate-risk patients in Europe after receiving the CE mark for this indication. Data from the Sapien 3 study indicate that the device is associated with superior outcomes to surgery in intermediate-risk patients.
A press release reports that the Sapien 3 valve builds on Edwards Lifesciences’ decades of experience in the development of tissue heart valves, and the proven benefits of the Edwards Sapien valves. It adds that 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, and that the FDA approved the Sapien 3 valve for the treatment of intermediate-risk patients in August.
Helge Möllmann (Clinic for Internal Medicine (Cardiology) at St. Johannes Hospital, Dortmund, Germany), comments: “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 transcatheter aortic valve implantation in intermediate-risk patients based on growing clinical evidence.”
While the only TAVI device to be approved for intermediate-risk patients in the USA, Sapien 3 is the second device to be approved in Europe for this indication. CoreValve Evolut R received CE mark approval for an expanded indication, for intermediate-risk patients, at the beginning of August.