Favorable coverage decision for leadless cardiac pacemakers in Norway

Norway has a national framework for the introduction of new health technologies within the specialist health service, known as the "New Methods" framework. This framework requires that all innovations undergo a national or hospital-based health technology assessment (HTA) prior to funding approval.

The leadless pacemaker (Micra™ Transcatheter Pacing System by Medtronic) for the treatment of cardiac arrhythmias has been under evaluation within the "New Methods" framework since 2023. This represents a reassessment of the technology: it was initially assessed between 2016 and 2018, resulting in a negative funding decision at that time.

In December 2024, a rapid technology reassessment titled “A leadless pacemaker, Micra™ Transcatheter Pacing System, in sub-groups of patients with indication for single-chamber ventricular pacing” was published by the Norwegian Medical Products Agency (NOMA).

On June 16, 2025, the Decision Forum for the “New Methods” framework decided to introduce leadless pacemakers for use in the treatment of atrial fibrillation and bradycardia in the following patient groups:

• Patients with stage 5 chronic renal failure (ESRD);
• Patients with a history of endocarditis or other conditions involving a very high risk of pacemaker lead infection;
• Patients requiring an epicardial electrode.

See the full details here.

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