Product brochure
Learn more about SAPIEN M3 TMVR system
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SAPIEN M3 System
Transcatheter Mitral Valve Replacement (TMVR)
Touch more lives.
Treat more MR.
The first and only approved fully transseptal approach to mitral valve replacement built on proven SAPIEN technology. The SAPIEN M3 system is indicated for patients with symptomatic moderate-to-severe or severe MR or symptomatic MAC-associated mitral valve dysfunction, including MR and/or MS, who are unsuitable for surgery or TEER.*
*MAC-associated mitral valve dysfunction includes moderate-to-severe or severe MR, severe MS, or moderate MR with moderate MS. See the Instructions for Use (IFU) for full indications.
MAC - mitral annular calcification; MR - mitral regurgitation; MS - mitral stenosis; TEER - transcatheter edge-to-edge repair
Learn more about the SAPIEN M3 System
Medical device for professional use
Medical device for professional use
For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).
PP--EU-10935 v3.0