Edwards has received Food and Drug Administration approval for its Sapien M3 mitral valve replacement system, the company said Tuesday.
The device is intended for people with moderate to severe mitral regurgitation, a heart condition where the valve between the left heart chambers doesn’t fully close, allowing blood to leak back through. Sapien M3 is indicated for people who are deemed unsuitable for surgery or transcatheter edge-to-edge repair therapy, a minimally invasive procedure to fix a valve by clipping its leaflets together.
Edwards says its Sapien M3 device is the first transcatheter therapy using a transseptal approach that has been approved by the FDA for mitral regurgitation. The procedure consists of two steps: delivering a dock, followed by delivering a valve to completely replace the mitral valve.
The approval was supported by results of a 299-person, single-arm pivotal trial. According to results published in the Lancet, patients saw significant elimination of mitral regurgitation and meaningful improvements in symptoms and quality of life.
The addition of a valve replacement option could extend treatment to new patients who have not been addressed before, Daveen Chopra, Edwards’ vice president of transcatheter mitral and tricuspid therapies, said at an analyst day earlier this month.
In 2022, Edwards received FDA approval for its Pascal Precision system for mitral valve repair. Earlier this year, the company received Europe’s CE mark for the Sapien M3 system.
