FDA Approves Expanded Indication Study for Edwards' Sapien 3 TAVR Device

January 15, 2016—Edwards Lifesciences Corporation announced that the US Food and Drug Administration has approved an expanded indication study of the Edwards Sapien 3 valve, the company’s most advanced transcatheter aortic valve replacement (TAVR) device. The Edwards Sapien 3 valve was approved by the US Food and Drug Administration in 2015 for the treatment of high-risk patients with severe, symptomatic aortic stenosis (AS) in the United States.

According to Edward Lifesciences, the investigational device exemption study will enroll elderly patients with severe, symptomatic 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 (SAVR).

Patients enrolled in the new PARTNER III trial will be randomized to receive either TAVR with Sapien 3 or SAVR. To be eligible for the trial, patients must be at least 65 years of age, exhibit symptoms of severe AS, and be determined by a heart team to have a surgical risk score of less than 4% per the Society of Thoracic Surgeons adult cardiac surgery risk calculator. The trial is a noninferiority study with a 1-year composite endpoint that includes death, stroke, and rehospitalization.

Enrollment of approximately 1,300 patients at up to 50 sites in the United States is expected to begin during the second quarter. Edwards Lifesciences advised that the trial will also include a 400-patient substudy using advanced imaging to evaluate leaflet motion in tissue heart valves.