Edwards Lifesciences has secured approval from the US Food and Drug Administration (FDA) for the expanded use of Edwards SAPIEN 3 transcatheter heart valve to treat patients suffering from severe, symptomatic aortic stenosis who are at intermediate risk for open-heart surgery.
The SAPIEN 3 valve has become the first transcatheter aortic valve replacement (TAVR) therapy to secure this indication in the country.
Edwards Lifesciences 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."
The intermediate-risk approval for the SAPIEN 3 valve was given based on data from a cohort of the PARTNER II Trial, which studied 2,005 intermediate-risk patients at 51 locations in North America.
This study indicated that patients treated with the SAPIEN 3 valve saw significant improvements for the primary endpoint of mortality, stroke and moderate or severe aortic regurgitation at one year than those treated with surgery.
The expanded intermediate-risk indication enables heart teams to treat patients with the SAPIEN 3 valve who they determine to be a risk of surgical mortality of greater than or equal to 3% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score.