The lead’s diameter is 4.7 Fr, or 1.6 mm, roughly equal to graphite in a wooden pencil.
The FDA approved OmniaSecure early last year for right ventricle placement to treat ventricular tachyarrhythmias, ventricular fibrillation (VT/VF) and bradyarrhythmias in adults and pediatric patients ages 12 and up.
Medtronic engineered OmniaSecure from its Medtronic SelectSecure Model 3830 pacing lead, which the company says has delivered safe and reliable therapy to patients for more than 20 years.
The first cases are now taking place at hospitals across the United States.
“We’re proud to bring this technology to patients in the United States, where ICDs play a vital role in protecting people from sudden cardiac death. 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,” said Trevor Cook, VP and GM of Defibrillation Solutions within Medtronic’s Cardiac Rhythm Management business. “We’re excited to put this innovation in physicians’ hands so they can continue providing exceptional care to their patients.”
The first U.S. commercial cases come on the heels of the final results from the LEADR (Lead Evaluation for Defibrillation and Reliability) pivotal trial, which demonstrated high defibrillation efficacy, safety, and reliability for OmiaSecure leads. Presented at the Asia Pacific Heart Rhythm Society Scientific Sessions, the results included high defibrillation success at implant (97.5%) and in the ambulatory setting through 3 years (95.3%), and most patients (96.5%) were free of OmniaSecure lead-related major complications.
