Edwards Lifesciences has announced that the FDA has approved its latest transcatheter aortic valve implantation (TAVI) system—Sapien 3—for the treatment of high-risk patients suffering from severe, symptomatic aortic stenosis. According to a press release, the Sapien 3 valve builds on Edwards’ decades of experience in the development of tissue heart valves and the proven benefits of the existing Sapien valves.
The new valve, available in 20mm, 23mm, 26mm and 29mm sizes, has an outer skirt—a cuff of fabric surrounding the valve frame—providing a seal to address paravalvular leak. The FDA approved is based on data from a cohort of the PARTNER II trial, which enrolled 583 high-risk patients at 29 US sites.
Martin B Leon (director of the Center for Interventional Vascular Therapy, NewYork-Presbyterian/Columbia University Medical Center, New York, USA), co-principal investigator for the PARTNER II trial, says: “The Sapien 3 valve sets a new standard for transcatheter heart valve performance and patient outcomes. We have seen some of the best results to date from the PARTNER II trial in treating high-risk patients with the Sapien 3 valve. The PARTNER II study concluded that this new valve reduced several complications associated with the TAVI procedure such as paravalvular leakage and stroke, and represented a meaningful improvement over data from prior studies with earlier-generation devices.”
The press release reports that the FDA approval is earlier than anticipated and expects the launch of the deivce to be largely completed by the end of the year. Sapien 3 has been commercially available in Europe since January 2014. The Sapien family of valves has been used in the treatment of more than 100,000 patients globally.