Skip to main content
Edwards Lifesciences Logo
Edwards Lifesciences Logo

SAPIEN M3 System for Transcatheter Mitral Valve Replacement (TMVR)

Sapien M3 hero
Sapien M3 hero
Sapien M3 hero
Introducing the SAPIEN M3 system for TMVR

Touch more lives.
Treat more MR.

The first and only approved transseptal approach to mitral valve replacement. Built on proven SAPIEN technology, designed to treat mitral regurgitation (MR).

The opportunity to advance mitral regurgitation care

MR is the most common valvular heart disease, but severe MR is still undertreated.1,2,3,4,5 

10%

of adults over 75 years of age are affected by MR.6,7

79%

of patients with isolated moderate-to-severe MR and a Class I surgical indication go untreated.2*

50%

mortality rate for non-operated patients with severe MR at 5 years.8

*Based on US data.

Clinically relevant MR is associated with a poor quality of life and may include symptoms like:1,9,10 

Shortness of breath
Shortness of breath
Shortness of breath

Shortness of breath

Feeling fatigued
Feeling fatigued
Feeling fatigued

Feeling fatigued

Swelling of hands and feet
Swelling of hands and feet
Swelling of hands and feet

Swelling of hands and feet

Heart palpitations
Heart palpitations
Heart palpitations

Heart palpitations

The SAPIEN M3 system for TMVR

Treat more MR with the SAPIEN M3 system for patients experiencing symptomatic moderate-to-severe or severe MR deemed unsuitable for surgery or transcatheter edge-to-edge repair (TEER) therapy.

The SAPIEN M3 system for TMVR
The SAPIEN M3 system for TMVR
The SAPIEN M3 system for TMVR
The SAPIEN M3 system for TMVR
The SAPIEN M3 system for TMVR
The SAPIEN M3 system for TMVR

MR treatment reimagined

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

‌

SAPIEN M3 dock

SAPIEN M3 dock
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

  1. 1
    Radiopaque markers to visualize proper positioning and deployment
  2. 2
    Nitinol PVL guard expands in the medial commissure
  3. 3
    Functional turns provide a stable anchor for the  SAPIEN M3 valve
  4. 4
    Encircling turn captures the native mitral leaflets

A novel dock: Fully repositionable and retrievable prior to dock release.

SAPIEN M3 dock
SAPIEN M3 dock
SAPIEN M3 dock
SAPIEN M3 valve
SAPIEN M3 valve
SAPIEN M3 valve

SAPIEN M3 valve

SAPIEN M3 valve
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.

The SAPIEN M3 system substantially reduces MR‡

Transseptal access
Transseptal access
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.11

Dock delivery
Dock delivery
Dock delivery

Dock delivery

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

Valve delivery
Valve delivery
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
Final implant

Final implant

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

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

The ENCIRCLE Trial

A prospective, single arm, multicenter, pivotal, adaptive design study.

The ENCIRCLE Trial
The ENCIRCLE Trial
The ENCIRCLE Trial

Trial objective

Establish the safety and effectiveness of the SAPIEN M3 system in subjects with symptomatic, at least 3+ MR for whom commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomical, or technical considerations.

Primary endpoint

Non-hierarchical composite of death & heart failure rehospitalization at 1 year.

Secondary endpoints

  • Improvement in New York Heart Association (NYHA) functional class at 1 year compared to baseline
  • Improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score at 1 year compared to baseline
  • Improvement in MR at 1 year compared to baseline
  • Decrease in left ventricular end-diastolic volume index (LVEDVi) at 1 year compared to baseline

Follow-up

30 days, 6 months, 1 year, and annually through 5 years.

Learn more about the ENCIRCLE trial

MAC, mitral annular calcification.

§Refer to Clinical Study Protocol for full enrollment criteria.

Helpful resource

Read more about SAPIEN M3 TMVR system.

Download brochure
Helpful resource
Helpful resource
Helpful resource

Sign up to learn more about the SAPIEN M3 system and stay connected to Edwards Lifesciences

Fill in your information below to stay up to date on the latest advancements from Edwards Lifesciences

If you would like further information about our privacy policy, please click here.

Would you like to opt-in to receive future email communications from 
Edwards Lifesciences?

This includes notification of future symposia, forums, conference activities, product updates, and educational events.

References

  1. Mitral Valve Regurgitation. Penn Medicine. Accessed November 20, 2024. https://www.pennmedicine.org/for-patients-and-visitors/patient-information/conditions-treated-a-to-z/mitral-valve-regurgitation
  2. Dziadzko V, Clavel MA, Dziadzko M, et al. Outcome and undertreatment of mitral regurgitation: a community cohort study. Lancet. 2018;391(10124):960-969. doi:https://doi.org/10.1016/s0140-6736(18)30473-2
  3. Cahill TJ, Prothero A, Wilson J, et al. Community prevalence, mechanisms and outcome of mitral or tricuspid regurgitation. Heart. 2021;107(12):1003-1009. doi:https://doi.org/10.1136/heartjnl-2020-318482
  4. Iung B, Delgado V, Rosenhek R, et al. Contemporary Presentation and Management of Valvular Heart Disease. Circulation. 2019;140(14):1156-1169. doi:https://doi.org/10.1161/circulationaha.119.041080
  5. Messika‐Zeitoun D, Candolfi P, Vahanian A, et al. Dismal Outcomes and High Societal Burden of Mitral Valve Regurgitation in France in the Recent Era: A Nationwide Perspective. Am Heart J. 2020;9(15). doi:https://doi.org/10.1161/jaha.120.016086
  6. Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):1005-1011. doi:https://doi.org/10.1016/S0140-6736(06)69208-8
  7. Praz F, Brugger N, Kassar M, et al. Interventional treatment of mitral valve regurgitation: an alternative to surgery? Swiss Med Wkly. 2019;149:w20023. doi:https://doi.org/10.4414/smw.2019.20023
  8. Goel SS, Bajaj N, Aggarwal B, et al. Prevalence and Outcomes of Unoperated Patients With Severe Symptomatic Mitral Regurgitation and Heart Failure. Am J Cardiol. 2013;63(2):185-186. doi:https://doi.org/10.1016/j.jacc.2013.08.723
  9. Sodhi N, Lim DS. Transcatheter Treatment of Functional Mitral Regurgitation in Patients with Heart Failure: The COAPT Trial. In: Key Trials of the Decade, an Issue of Interventional Cardiology Clinics. Elsevier Health Sciences; 2020:451-459.
  10. Lim DS, Reynolds MR, Feldman T, et al. Improved Functional Status and Quality of Life in Prohibitive Surgical Risk Patients With Degenerative Mitral Regurgitation After Transcatheter Mitral Valve Repair. Am J Cardiol. 2014;64(2):182-192. doi:https://doi.org/10.1016/j.jacc.2013.10.021
  11. 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).