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Medical device JCA

HighLife trans-septal mitral valve replacement system: EU joint clinical assessment

Moderate-to-severe or severe primary and/or secondary mitral regurgitation with LVEF ≥30% and LVEDD ≤70 mm, without severe mitral annular calcification, in patients a heart team deems unsuitable for surgery or TEER

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

Overview

Company
HighLife SAS
Therapy area
Cardiovascular · Mitral valve
Indication
Moderate-to-severe or severe primary and/or secondary mitral regurgitation with LVEF ≥30% and LVEDD ≤70 mm, without severe mitral annular calcification, in patients a heart team deems unsuitable for surgery or TEER
Product type
Medical device
Selected for JCA
2 Oct 2026 (Commission decision; announced 6 Oct 2026)
JCA assessor
HAS, France
Co-assessor
AOTMiT, Poland
Regulatory status
CE marked January 2026; the next-generation Clarity valve was CE marked in August 2026. Manufacturer: HighLife SAS. 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
European/Australian feasibility study (NCT04029363), first 30 consecutive patients; company-reported 4-year data on the first 35 (Single-arm)
01

Scope

The PICO forecast

JCA Pulse forecasts 1–2 PICOs for HighLife trans-septal 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

HighLife trans-septal mitral valve replacement system rests on European/Australian feasibility study, 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 HighLife trans-septal mitral valve replacement system dossier and projects the indirect comparison each comparator will need.

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04

Countries

National translator and outlook

France and Poland lead the joint assessment. Pro explains what the JCA means for the national route in each of 31 markets, with 1 national record already in place.

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Next milestones

  • 2 Oct 2026Selected for JCA · EU · 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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