Sapien 3 is claimed to be the first transcatheter aortic valve replacement (TAVR) therapy approved to treat patients suffering from severe and symptomatic aortic stenosis who have been determined by a heart team to be at intermediate risk for open-heart surgery.
The approval was based on data from a cohort of the PARTNER II trial, which assessed 2,005 intermediate-risk patients at 51 sites in the US and Canada.
According to the company, the study showed 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 compared to those treated with surgery.
Last March, the firm obtained approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the Sapien 3 valve to treat patients suffering from severe and symptomatic aortic stenosis.
In June 2015, the Sapien 3 valve received FDA approval to treat patients with severe and symptomatic aortic stenosis who are at high-risk for open heart surgery.
Edwards transcatheter heart valves corporate vice president Larry Wood said: "The intermediate-risk approval of the Sapien 3 valve is a major milestone, since it provides a less-invasive therapy that has demonstrated better outcomes for aortic valve patients, and is supported by the largest and rigorous comparative body of evidence for the treatment of aortic stenosis.”
