Edwards Receives FDA Approval For Expanded Indication Study Of SAPIEN 3 Valve

Edwards Lifesciences Corporation

, the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced U.S. Food and Drug Administration approval for an expanded indication study of its most advanced transcatheter aortic heart valve, the Edwards SAPIEN 3 valve. The investigational device exemption (IDE) study will enroll elderly patients with severe, symptomatic aortic stenosis (AS) who have been determined by a heart team to be at low risk for mortality if they were to undergo surgical aortic valve replacement. Patients enrolled in the new PARTNER III Trial will be randomized to receive either the SAPIEN 3 valve or open surgical valve replacement. To be eligible for the trial, patients must be at least 65 years old, exhibit symptoms of severe AS and be determined by a heart team to have a surgical risk score of less than 4 percent per the Society of Thoracic Surgeons adult cardiac surgery risk calculator. The trial is a non-inferiority study with a one-year composite endpoint that includes death, stroke and rehospitalization. Enrollment of approximately 1,300 patients at up to 50 sites is expected to begin during the second quarter. The trial will also include a 400-patient sub-study using advanced imaging to evaluate leaflet motion in tissue heart valves. "If this trial is successful, it will allow heart teams to choose a treatment approach that is best suited to every patient's individual need. We are pleased to begin this important study of the SAPIEN 3 transcatheter valve to evaluate its safety and effectiveness in a broader group of elderly patients suffering from this deadly disease," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves. The SAPIEN 3 valve was approved in the United States in 2015 for the treatment of high-risk patients suffering from severe, symptomatic AS.