SAPIEN M3 is a transcatheter mitral valve replacement (TMVR) system designed to treat symptomatic moderate-to-severe or severe mitral regurgitation (MR) in patients considered unsuitable for surgery or transcatheter edge-to-edge repair (TEER), as determined by a multidisciplinary heart team.
It is also indicated for symptomatic mitral valve dysfunction linked to mitral annular calcification, including moderate-to-severe or severe MR, severe mitral stenosis (MS), or combined moderate MR with moderate MS, in patients deemed unsuitable for surgery or TEER.
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Developed by Edwards Lifesciences, the system received a CE Mark in April 2025, becoming the first approved transfemoral TMVR system globally.
In December 2025, SAPIEN M3 became the first transseptal transcatheter therapy to secure US Food and Drug Administration (FDA) approval for the treatment of MR.
SAPIEN M3 system design and features
The SAPIEN M3 TMVR system comprises two components: the SAPIEN M3 dock and the SAPIEN M3 valve.
The SAPIEN M3 nitinol dock encircles the native mitral anatomy to create a stable, standardised landing zone for the SAPIEN M3 valve. Radiopaque markers support visualisation of correct positioning and deployment.
The dock also incorporates a nitinol paravalvular leak guard that expands at the medial commissure, while functional turns provide stable anchoring for the SAPIEN M3 valve. Additionally, the dock features an encircling turn designed to capture the native mitral leaflets.
The dock exerts an inward force on the mitral apparatus, drawing the leaflets and chordae towards the centre of the docking system and bringing the papillary muscles closer together.
The SAPIEN M3 valve, designed to treat the mitral valve, features a cobalt-chromium alloy frame, which provides radial strength and clear fluoroscopic visibility.
It also incorporates tri-leaflet bovine pericardial tissue treated with the ThermaFix tissue process, and a full-frame polyethylene terephthalate skirt.
A single 29mm valve size is designed to treat a range of mitral anatomies.
SAPIEN M3 delivery system details
The SAPIEN M3 delivery platform includes the Edwards 23F Guide Sheath, the SAPIEN M3 dock steerable catheter and the Edwards Commander M delivery system.
The low-profile Edwards 23F Guide Sheath provides venous vascular access to cardiac structures, supporting the introduction and removal of SAPIEN M3 transcatheter mitral valve replacement devices.
It is used to deliver both the dock and the valve, enabling a minimally invasive transseptal approach to TMVR.
The SAPIEN M3 dock steerable catheter supports precise, responsive control for navigating and positioning the dock, which can be repositioned and retrieved before release.
The Edwards Commander M delivery system incorporates on-balloon valve crimping to facilitate precise valve placement and a controlled deployment process.
Overall, the SAPIEN M3 system is designed to achieve substantial MR reduction, supported by a demonstrated safety profile and clinically meaningful improvements in patient health status.
Clinical study on SAPIEN M3 system
The safety and efficacy of the SAPIEN M3 system were evaluated in the ENCIRCLE single-arm, multi-centre, pivotal, adaptive design study.
The study’s primary endpoint was a non-hierarchical composite of all-cause death and heart failure rehospitalisation at one year.
Secondary endpoints measured at one year versus baseline included: improvement in New York Heart Association functional class; improvement in the Kansas City Cardiomyopathy Questionnaire overall score; improvement in MR severity; and a reduction in left ventricular end-diastolic volume index.
The trial met its primary and secondary safety and effectiveness endpoints in the main cohort, comprising 299 patients who were considered unsuitable for other treatment options.
Investigators reported significant MR elimination, with 95.7% of patients achieving MR ≤0/1+, alongside significant improvements in symptoms and quality of life.
The main cohort also recorded low rates of death and low rates of heart failure hospitalisation at one year following treatment with SAPIEN M3.
