Medtronic lead wins expanded OK
Medtronic’s OmniaSecure defibrillator lead received expanded approval for left‑bundle‑branch placement, broadening options for conduction‑system pacing in device therapy. ( - )
The U.S. Food and Drug Administration expanded OmniaSecure’s label on March 23, 2026, via a Medtronic press release issued from Galway, Ireland. (news.medtronic.com) The LEADR LBBAP clinical program (ClinicalTrials.gov NCT04863664) enrolled patients for left‑bundle‑branch‑area implantation and reported 100% defibrillation success at implant in the cohort presented. (clinicaltrials.gov) The pivotal LEADR LBBAP results cited a low OmniaSecure‑related major complication rate of roughly 2.1% at three months when the lead was placed for physiologic pacing. (marketchameleon.com) OmniaSecure is a lumenless, small‑diameter defibrillation lead measured at 4.7 French (≈1.66 mm) and is labeled for adults and adolescent patients aged 12 years and older. (news.medtronic.com) Medtronic built OmniaSecure on the same platform lineage as its SelectSecure Model 3830 pacing lead, which previously secured FDA clearance for conduction‑system pacing, and the OmniaSecure lead began U.S. commercial availability in January 2026 with first cases reported mid‑January. (acc.org) Medtronic and investigators have highlighted potential use of OmniaSecure in LOT‑CRT (left‑bundle‑branch‑optimized CRT) and signaled that longer‑term LEADR datasets and extended LBB area outcomes are slated for presentation at upcoming HRS scientific sessions. (prnewswire.com)
