Medtronic has announced that its OmniaSecure™ defibrillation lead has received approval from the U.S. Food and Drug Administration (FDA), signifying a significant advancement in implantable cardioverter-defibrillator (ICD) technology.
The OmniaSecure lead is the world’s smallest transvenous defibrillation lead, measuring just 4.7 French in diameter. This novel, lumenless design, is based on Medtronic’s established SelectSecure Model 3830 pacing lead, which has been in use since 2003. The OmniaSecure lead incorporates a thickened layer of polyurethane insulation on the high-voltage conductor, enhancing its durability and flexibility.
The FDA approval was supported by the results of the global Lead Evaluation for Defibrillation and Reliability (LEADR) pivotal trial, which enrolled 643 patients. The trial demonstrated a 97.5% success rate in defibrillation testing at implantation and a 97.1% freedom from lead-related major complications at both 6 and 12 months. Notably, there were zero lead fractures reported during the study period.
Advanced cardiac lead reliability modeling projects a 98.2% fracture-free survival rate of the OmniaSecure lead at 10 years, including a 97.9% rate in adolescents. This performance exceeds both the modeled and clinical 10-year performance of the highly reliable, larger diameter Sprint Quattro lead.
The OmniaSecure lead is compatible with many commercially available catheters and is designed for targeted placement in the right ventricle. Its small diameter may reduce the risk of venous occlusion and tricuspid valve complications associated with larger leads.
Medtronic plans to present additional results from the LEADR study in the coming months and has initiated another study assessing the OmniaSecure lead when placed at the left bundle branch area in patients eligible for an ICD or left bundle branch-optimized cardiac resynchronization therapy (LOT-CRT).
Disclaimer: This news article is for informational purposes only and does not constitute medical advice. Patients should consult with their healthcare providers for personalized medical guidance.
