Edwards Lifesciences wins FDA nod for new Sapien 3 trial

Edwards Lifesciences (NYSE:EW) said today that the FDA approved a new trial of its Sapien 3 replacement heart valve.

The Sapien 3 transcatheter aortic valve replacement was approved last year by the federal safety watchdog for patients at high risk of death from open surgical procedures to replace their aortic valve. The new investigational device exemption for the Partner III trial is designed to evaluate the Sapien 3 TAVR in patients with a low mortality risk from open surgical valve replacement, the Irvine, Calif.-based company said.

“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,” transcatheter heart valves vice president Larry Wood said in prepared remarks.

The non-inferiority Partner III study is designed to randomize roughly 1,300 subjects to either treatment with Sapien 3 or open surgical replacement. Patients must be 65 or older with symptoms of severe aortic stenosis with a surgical risk score of less than 4% according to Society for Thoracic Surgery guidelines, Edwards said.

The composite endpoint includes rates of death, stroke and rehospitalization after 1 year. The study is slated to launch during the 2nd quarter, the company said, and is due to include a 400-patient imaging portion designed to evaluate leaflet motion.

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