Medtronic has received FDA approval for its OmniaSecure defibrillation lead, the smallest of its kind at 4.7 French (1.6 mm), for use in the right ventricle. Designed to treat serious heart rhythm disorders such as ventricular tachyarrhythmias and bradyarrhythmias, the lead connects to implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). Built on the SelectSecure Model 3830 pacing platform, the OmniaSecure lead is suitable for adult and adolescent patients aged 12 and older, including those with smaller anatomical structures. Clinical results from the LEADR Pivotal Trial supported the FDA’s approval, demonstrating safety and effectiveness in standard right ventricular implantation.
In addition, Medtronic is evaluating the use of the OmniaSecure lead in the left bundle branch (LBB) area, which may allow for pacing that better reflects the heart’s natural conduction. Alan Cheng, M.D., Chief Medical Officer of the Cardiac Rhythm Management, a part of the company’s Cardiovascular Portfolio, stated, "This milestone underscores our commitment to driving clinical innovations that help patients today while paving the way for future innovations that will usher in the next era of electrophysiology." With no major procedure-related complications reported, the study indicates strong potential for LBB placement. The investigational use of OmniaSecure in this area remains subject to future FDA review. Medtronic continues to study the lead’s long-term performance across multiple international sites.
