Edwards Lifesciences has secured expanded indication from the US Food and Drug Administration (FDA) for the use of its Sapien 3 transcatheter heart valve (THV) in aortic and mitral valve-in-valve procedures.
The tool can now be used to treat symptomatic heart disease patients, whose previous bioprosthetic aortic or mitral valve has failed or who are at high-risk of death or severe complications from repeat surgery.
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Originally, Sapien 3 was approved for transcatheter aortic valve replacement (TAVR) in 2015 as an alternative option to surgical aortic valve replacement for native aortic stenosis patients who are at greater risk of death or severe complications from surgery.
FDA Centre for Devices and Radiological Health cardiovascular devices division director Bram Zuckerman said: "This new approval offers US patients with failing surgical bioprosthetic aortic or mitral valves a less invasive treatment option."
The current approval is based on real-world data collected from the Transcatheter Valve Therapy Registry of Society of Thoracic Surgeons and American College of Cardiology.
The clinical safety and efficacy data from 314 patients who had undergone aortic valve-in-valve procedures and 311 mitral valve-in-valve procedural patients, showed clinically meaningful improvement in 85% of patients’ heart failure symptoms at 30 days following the procedure.
