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Friday, April 25, 2025

Medtronic Receives FDA Approval For Smallest-Diameter, Lumenless Defibrillation Lead



Medtronic (NYSE: MDT) has received FDA approval for its OmniaSecure™ defibrillation lead, the world's smallest defibrillation lead at 4.7 French (1.6mm). The device is approved for right ventricle placement in adults and pediatric patients aged 12 and up.

The lead, built on the SelectSecure™ Model 3830 pacing lead platform, connects to implantable defibrillators to treat life-threatening heart rhythm conditions. The company also presented investigational study results at Heart Rhythm 2025, showing 100% defibrillation success when the lead is implanted in the left bundle branch (LBB) area.

The LEADR LBBAP clinical study demonstrated a 95.8% successful implantation rate in the first 193 patients, with no procedure-related major complications. The study enrolled approximately 300 patients across 24 sites in 11 countries. The smaller diameter aims to reduce complications such as venous occlusion and tricuspid valve regurgitation.

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