The FDA approved an investigational device exemption study evaluating the Sapien 3 valve in elderly patients with severe, symptomatic aortic stenosis who are at low risk for mortality.
Edwards Lifesciences, the device’s manufacturer, announced the study in a news release on Jan. 15.
Edwards plans on enrolling approximately 1,300 patients in the PARTNER III study at up to 50 sites beginning in the second quarter of 2016. Eligibility requirements included patients who are at least 65 years old, have severe aortic stenosis and have a surgical risk score of less than 4 percent based on the Society of Thoracic Surgeons adult cardiac surgery risk calculator.
Patients in the non-inferiority study will be randomized to receive the Sapien 3 valve or open surgical valve replacement. The one-year composite endpoint includes death, stroke and rehospitalization.
In June 2015, the FDA approved the Sapien 3 valve for high-risk patients with severe aortic stenosis.