Medtronic has commercially launched the OmniaSecure defibrillation lead in the USA this week, with the first cases being performed at hospitals across the country.
OmniaSecure is described by the company as “the world’s smallest defibrillation lead”. It has been approved for adults and paediatric patients aged 12 years and older. The device connects to an implantable defibrillator to treat heart rhythm issues like ventricular tachyarrhythmias, ventricular fibrillation and bradyarrhythmias.
Medtronic states that implantable cardioverter defibrillators (ICDs) are the standard for preventing sudden cardiac death, and existing defibrillation leads are larger in diameter than OmniaSecure—with these larger-diameter leads may increase the potential for downstream complications, such as venous occlusion or tricuspid valve regurgitation.
The lead was engineered from the proven Medtronic SelectSecure Model 3830 pacing lead, which has delivered safe and reliable therapy to patients for more than 20 years, as per a company press release.
Prior to this commercial launch, the final results from the LEADR pivotal trial were presented at the 2025 Asia Pacific Heart Rhythm Society (APHRS) Scientific Sessions (12–15 November, Yokohama, Japan), reaffirming the lead’s established performance and reliability with high defibrillation success and low rates of lead-related major complications.
“We’re proud to bring this technology to patients in the USA, where ICDs play a vital role in protecting people from sudden cardiac death,” said Trevor Cook, vice president and general manager of defibrillation solutions within Medtronic’s Cardiac Rhythm Management business. “The novel, small-diameter OmniaSecure defibrillation lead is engineered for long‑term reliability and delivers dependable therapy when paired with a transvenous ICD or CRT‑D [cardiac resynchronisation therapy with defibrillator]. We’re excited to put this innovation in physicians’ hands so they can continue providing exceptional care to their patients.”
