Skip to main content
Edwards Lifesciences Logo

SAPIEN M3 System

Transcatheter Mitral Valve Replacement (TMVR)

Sapien M3

Explore the features

The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system substantially reduces mitral regurgitation (MR) and improves quality of life.*

*Summary of Safety & Clinical Performance (SSCP) on file.

SAPIEN M3 dock

SAPIEN M3 dock

Encircles and captures the native mitral leaflets to create a stable and standardized landing zone for the SAPIEN M3 valve. The dock is fully repositionable and retrievable prior to dock release.

  • Radiopaque markers to visualize proper positioning and deployment
  • Nitinol PVL guard expands in the medial commissure
  • Functional turns provide a stable anchor for the  SAPIEN M3 valve
  • Encircling turn captures the native mitral leaflets

A novel dock: Applies an inward force to the mitral apparatus, approximating the papillary muscles.

PVL, paravalvular leak. 

SAPIEN M3 valve

SAPIEN M3 valve

Built on the proven SAPIEN technology, optimized to treat mitral regurgitation

  1. 1
    Cobalt-chromium alloy frame provides radial strength and good visibility under fluoroscopy
  2. 2
    Trileaflet bovine pericardial tissue treated with the ThermaFix tissue process
  3. 3
    Full-frame PET skirt respects the native anatomy
  4. 4
    Single 29mm valve can treat a variety of mitral anatomies

A legacy of success: The SAPIEN platform has been used in over 1 million procedures globally, including the use of the SAPIEN 3 platform in 8,000+ mitral procedures.†

PET, polyethylene terephthalate. 

†As of Q1 2024.

MR treatment reimagined

Watch the procedural animation below to see the latest evolution of the SAPIEN technology, designed to treat the mitral valve

Transseptal access

Transseptal access

The low-profile Edwards 23F inner diameter guide sheath is used for both the dock and valve delivery, providing a minimally invasive transseptal approach to TMVR.1

Dock delivery

Dock delivery

The SAPIEN M3 dock steerable catheter enables responsive navigation and positioning of the dock.

Valve delivery

Valve delivery

The Edwards Commander M delivery system uses on-balloon valve crimping and allows accurate valve positioning for controlled deployment.

Final implant

Final implant

The SAPIEN M3 system substantially reduces MR and improves quality of life.‡

‡Summary of Safety & Clinical Performance (SSCP) on file.

Learn more about the SAPIEN
M3 System

View clinical evidence
Clinical evidence

References

  1. Transcatheter Mitral Valve Replacement (TMVR). Penn Medicine. Accessed January 6, 2025. https://www.pennmedicine.org/for-patients-and-visitors/find-a-program-or-service/heart-and-vascular/heart-valve-disease/treatments-and-procedures/transcatheter-mitral-valve-replacement
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).