#SFHS2617166AFrance Adds Medtronic MICRA AV2 Leadless Pacemaker to Reimbursable Products List
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France adds Medtronic’s MICRA AV2 dual-chamber leadless pacemaker to the national list of reimbursable medical products. The device is covered for certain adult patients who cannot receive, or face high risks from, traditional dual-chamber pacemakers with leads. Hospitals and cardiology teams can use the reimbursement code for eligible cases, but implantation remains limited to authorized health facilities. Medtronic provides a 10-year warranty covering confirmed device malfunction under normal use.
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Key Changes
- Adds Medtronic MICRA AV2 to France’s reimbursable medical products list under code 3442135
- Defines eligible adult patients, including those contraindicated for lead-based pacemakers or at high risk of lead or pocket complications
- Requires use under existing rules limiting implantation to authorized health facilities and includes a 10-year manufacturer warranty
Obligations
What this law requires
Use reimbursement code 3442135 for MEDTRONIC MICRA AV2 only for adult patients contraindicated for, or at high risk of complications from, dual-chamber pacemakers with leads who require AV synchronisation at rest, have normal sinus function, and meet one of the listed high-degree atrioventricular block indications.
Do not treat MICRA AV2 as reimbursable for patients outside the covered indications listed in the nomenclature entry.
Limit implantation and use of MICRA AV2 to the prescription and use conditions applicable to the act of implanting a definitive cardiac pacemaker in the right ventricle by transcutaneous venous route, as restricted to certain authorised health facilities under the order of 26 February 2026.
Medtronic must provide a 10-year warranty for MICRA AV2 covering confirmed malfunction under normal conditions of use.