Medtronic: Medtronic wins FDA nod for world's smallest defibrillation lead

The OmniaSecure defibrillation lead. [Image courtesy of Medtronic] It built OmniaSecure on its reliable SelectSecure Model 3830 pacing lead for catheter delivery. It adds to the wide-ranging Medtronic portfolio of lead solutions for precise delivery and placement. Implantable cardioverter defibrillators (ICDs) provide life-saving cardiac interventions. But Medtronic aims to improve upon one area of weakness: the transvenous leads. Existing leads with large diameters may increase the potential for downstream complications. Those may inclue venous occlusion or tricuspid valve regurgitation. The medtech giant says OmniaSecure is the world's smallest defibrillation lead, coming in at 4.7 French, or 1.6mm. That equals about the diameter of graphite in a wooden pencil. OmniaSecure connects to an implantable defibrillator to treat potentially life-threatening ventricular tachyarrhythmias, ventricular fibrillation (VT/VF) and bradyarrhythmias. Medtronic says the small lead represents a "meaningful innovation in electrophysiology." Its indication covers the right ventricle for adults and adolescents aged 12 and up, including those with smaller anatomies. Data shared at Heart Rhythm Society (HRS) 2024 served as the basis for the lead's approval. "FDA approval for the OmniaSecure defibrillation lead furthers our ability to offer physicians and patients a transvenous solution designed to be smaller to help minimize complications−including vascular complications and valve interaction−with strong, reliable lead durability. We engineered the OmniaSecure lead based on the trusted SelectSecure Model 3830 pacing lead, which has been the lead of choice for many physicians for more than 20 years," said Dr. Alan Cheng , chief medical officer of the Cardiac Rhythm Management business at Medtronic. "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." Medtronic shares OmniaSecure data at HRS 2025 At HRS 2025 in San Diego, Dr. Pugazhendhi Vijayaraman presented data from the LEADR LBBAP study of OmniaSecure. LEADR LBBAP (Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing) demonstrated high defibrillation success with OmniaSecure when placed in the LBB area for patients indicated for an ICD or CRT-D. Investigators looked at placing the defibrillation lead in the LBB area as an alternative to right ventricular stimulation. It could extend to sensing, pacing, cardioversion and defibrillation. Medtronic's LEADR LBBAP study enrolled approximately 300 patients across 24 sites in 11 countries in North America, Europe, Asia and Australia. The study had 100% success in defibrillation testing at device implantation in 162 patients. That met the prespecified efficacy goal of 88%. Of the first 193 patients implanted in the study, investigators successfully implanted OmniaSecure, per protocol, in 95.8% of procedures. Physician investigators reported zero procedure-related major complications like early helix or lead fracture, system revision or death. "The option to place a lead in the left bundle branch area may provide for physiologic pacing by engaging the heart's natural conduction system. These positive preliminary results for the LEADR LBBAP study are encouraging and highlight the potential versatility of the OmniaSecure defibrillation lead," said Vijayaraman. OmniaSecure for use in the LBB area remains investigational and requires additional FDA approval in the future.