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FDA approves new indication for Edwards' Sapien 3 heart valve

MDBR Staff Writer Published 07 June 2017

Edwards Lifesciences has secured approval from the US Food and Drug Administration (FDA) for aortic and mitral valve-in-valve procedures using SAPIEN 3 transcatheter heart valve (THV).

The extended indication is the first approval for the SAPIEN 3 valve in the US for bioprosthetic valve replacement in aortic and mitral patients.

The Sapien 3 valve is claimed to be the first transcatheter heart valve that received approval in the US to treat both aortic and mitral patients who are at high risk for a subsequent open-heart surgery to replace their bioprosthetic valve.

The expanded approval was based on real-world data gathered from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry.

The TVT Registry is comprised of information and outcomes on patients undergoing transcatheter valve replacement and repair procedures in the US.

In 2015, the Edwards Sapien 3 valve had secured approval from the FDA to treat severe and symptomatic aortic stenosis patients at high risk for open-heart surgery.

Last year, the valve was approved for the treatment of patients who are at intermediate risk for open-heart surgery.

Edwards’ transcatheter heart valves corporate vice president Larry Wood said: "Expansion of the Sapien 3 device indication to include valve-in-valve procedures is a meaningful advancement for patients at high risk of an additional open-heart valve procedure, particularly for those in need of a safe alternative for mitral valve replacement.”

Earlier this year, Edwards Lifesciences acquired Valtech Cardio for about $690m, which produces ardioband system that is used for transcatheter repair of the mitral and tricuspid valves.

Edwards Lifesciences is engaged in the development of novel medical solutions for structural heart disease, as well as critical care and surgical monitoring.


Image: The Sapien 3 valve is the first transcatheter heart valve that received FDA approval to treat both aortic and mitral patients. Photo: courtesy of krishna arts / FreeDigitalPhotos.net.