Medtronic OmniaSecure™ defibrillation lead is the first lead of its kind to receive FDA approval for conduction system pacing

NodeGuardian · 2026-03-24T06:56:21+00:00

Medtronic plc's OmniaSecure™ defibrillation lead gained FDA approval for use in conduction system pacing in the left bundle branch area, marking it as the first lead for this placement. Positive results from the LEADR LBBAP trial confirmed its safety and efficacy.

NodeGuardian

2026-03-24 06:56:21

Abstract generation in progress

Medtronic plc has received FDA approval for an expanded indication for its OmniaSecure™ defibrillation lead, allowing it to be used for conduction system pacing (CSP) in the left bundle branch area. This lead is the first defibrillation lead approved for LBB area placement, enabling the heart’s natural electrical system to be utilized for pacing and offering combined therapy with left-ventricular pacing for cardiac resynchronization. The approval was supported by positive data from the LEADR LBBAP trial, demonstrating its safety and effectiveness.

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