Additional Relevant Details
The SAPIEN 3 valve intermediate-risk approval was based on data from a cohort of the PARTNER II Trial, which studied 2,005 intermediate-risk patients at 51 sites in the United States and Canada. The study demonstrated that patients treated with the SAPIEN 3 valve experienced clinically significant improvements for the composite primary endpoint of mortality, stroke and moderate or severe aortic regurgitation at one year as compared to those treated with surgery. The data were presented in April at the American College of Cardiology's 65th Annual Scientific Session and simultaneously published in The Lancet.