FDA Approves Third-Generation Sapien Transcatheter Heart Valve


June 18, 2015

BETHESDA, MA — The US Food and Drug Administration has approved the third-generation Sapien (Edwards Lifesciences) transcatheter heart valve for the treatment of patients with aortic stenosis[1].

The Sapien 3, which is approved for patients who are unable to undergo aortic-valve-replacement surgery or are considered high risk for surgery, includes a design change over previous iterations in that it includes a polyethylene terephthalate outer skirt designed to minimize paravalvular leak.

In the FDA announcement, the agency notes the rate of moderate or greater aortic insufficiency at 30 days is significantly reduced in patients treated with the Sapien 3 valve compared with those who received the older Sapien device.

The approval of the Sapien 3 valve was based on data from the PARTNER II S3 study, a clinical trial involving 583 patients with aortic-valve stenosis who were at high risk for aortic-valve-replacement surgery or who could not undergo the surgery due to excess risk.

As reported by heartwire , PARTNER II S3 investigators reported that 2.2% of those who underwent transcatheter aortic-valve replacement (TAVR) with the Sapien 3 device died at 30 days and 1.5% had a stroke. At 30 days, cardiovascular mortality was 1.4% and 0.9% of patients had a disabling stroke. When presented at the American College of Cardiology 2015 Scientific Sessions in March, investigators were impressed with the device's low frame height, improved frame geometry, and low delivery profile.

Edwards Lifesciences sponsored the PARTNER II S3 study.


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