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Medical device JCA

SAPIEN M3 transcatheter mitral valve replacement system: EU joint clinical assessment

Symptomatic moderate-to-severe or severe mitral regurgitation in patients a heart team deems unsuitable for surgery or transcatheter edge-to-edge repair (TEER)

  1. Regulatory review
  2. CHMP opinion
  3. EU authorised
  4. JCA report published

Overview

Company
Edwards Lifesciences
Therapy area
Cardiovascular · Mitral valve
Indication
Symptomatic moderate-to-severe or severe mitral regurgitation in patients a heart team deems unsuitable for surgery or transcatheter edge-to-edge repair (TEER)
Product type
Medical device
Selected for JCA
2 Oct 2026 (Commission decision; announced 6 Oct 2026)
JCA assessor
ZIN, The Netherlands
Co-assessor
Norwegian Medical Products Agency (DMP), Norway
Regulatory status
CE certificates already issued when selected. Manufacturer: Edwards Lifesciences. Dossier due 100 days after the Commission's request (+30 days possible).
Latest
CE marked; one unnamed Member State had a national assessment under way at selection.
Pivotal evidence
ENCIRCLE (prospective single-arm pivotal trial, 299 treated, 56 centres in 6 countries, Single-arm)
01

Scope

The PICO forecast

JCA Pulse forecasts 1–2 PICOs for SAPIEN M3 transcatheter mitral valve replacement system, with 2 candidate comparators. See the populations, comparators and likely outcomes the assessment is set to cover.

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02

Evidence

Fit against the likely scope

SAPIEN M3 transcatheter mitral valve replacement system rests on ENCIRCLE, evidence without a randomised comparator. Pro shows which likely PICOs it can answer, and where the gaps sit.

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03

Comparisons

Trials and indirect comparisons

Pro maps every trial likely in the SAPIEN M3 transcatheter mitral valve replacement system dossier and projects the indirect comparison each comparator will need.

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04

Countries

National translator and outlook

Netherlands and Norway lead the joint assessment. Pro explains what the JCA means for the national route in each of 31 markets, with 2 national records already in place.

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Next milestones

  • 2 Oct 2026Selected for JCA · EU · source
  • 10 Sep 2026HAS backs Forfait Innovation coverage · France · source

Sources

Last checked 5 November 2026. Compiled from public sources; check them for the latest position. Forecasts are Evidaxia’s independent view, not official assessments.

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