August 18, 2016
FDA Approves Expanded Indication for Edwards' Sapien 3 TAVR Device
August 18, 2016—Edwards Lifesciences Corporation announced US Food and Drug Administration (FDA) approval to expand use of its Sapien 3 transcatheter aortic valve replacement (TAVR) device for the treatment of patients with severe, symptomatic aortic stenosis who have been determined by a heart team to be at intermediate risk for open heart surgery.
The expanded intermediate-risk indication granted by the FDA enables heart teams to treat patients with the Sapien 3 valve who the physicians determine to have a predicted risk of surgical mortality of ≥ 3% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator.
In June 2015, the device was first approved by the FDA for the treatment of high-risk patients with severe, symptomatic aortic stenosis.
Prof. Vinod Thourani, MD, coprincipal investigator of the SAPIEN 3 study, commented in the company’s announcement, “The Sapien 3 valve has set a new standard for performance and patient outcomes with aortic valve replacement. The clinical outcomes of 1.1% mortality and 1% disabling stroke at 30 days in this intermediate-risk population treated with the Sapien 3 valve are changing the paradigm of how we treat patients with aortic stenosis.” Prof. Thourani is Co-Director of Emory Heart and Vascular Center's Structural Heart and Valve Center and Professor of Cardiothoracic Surgery at Emory University School of Medicine in Atlanta, Georgia.
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 1 year as compared to those treated with surgery.