Shots:
- The US FDA has approved Edwards Lifesciences’ SAPIEN M3 transcatheter mitral valve replacement (TMVR) system as the transseptal transcatheter therapy for the treatment of symptomatic moderate-to-severe or severe mitral regurgitation (MR)
- SAPIEN M3 is indicated for pts unsuitable for surgery or transcatheter edge-to-edge repair (TEER) therapy, including those with mitral valve dysfunction associated with mitral annular calcification (MAC); the fully percutaneous system is delivered via femoral venous access
- Approval was supported by one year data from the pivotal ENCIRCLE study (n=299), showing significant MR elimination (95.7% MR ≤0/1+) and meaningful improvements in symptoms and quality-of-life; data were presented at TCT’25 and published in The Lancet
Ref: Edwards Lifesciences | Image: Edwards Lifesciences | Press Release
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