Edwards Lifesciences Corp.'s Sapien 3 heart replacement valve was better than surgery in treating patients with certain heart conditions, meeting the main goal of a late-stage study.
The study, dubbed Partner 3, evaluated Sapien 3 in a minimally invasive procedure, known as transcatheter aortic valve replacement, among 1,000 patients with severe symptomatic aortic stenosis who were deemed to be at low risk of death from surgery. Aortic stenosis is the obstruction of blood flow across the aortic valve, with symptoms such as shortness of breath, fatigue, rapid or irregular heartbeat and palpitations.
Results showed that at 30 days, patients who received the Sapien 3 valve showed a 0.6% risk of stroke, compared to 2.4% for patients who underwent surgery with any commercially available surgical valve.
After one year, the risk of death, stroke and rehospitalization for Sapien 3 patients was at 8.5%, versus 15.1% for the surgery patient group.
Irvine, Calif.-based Edwards Lifesciences expects to receive the U.S. Food and Drug Administration's approval for Sapien 3's use in patients with low-risk patients with severe, symptomatic aortic stenosis late in 2019. The Sapien 3 heart valve is already approved by the FDA to treat intermediate and higher risk patients.
The results of Partner 3 trial were presented at the American College of Cardiology's 68th Annual Scientific Session held in New Orleans.