Dive Brief:
- Medtronic said its OmniaSecure defibrillation lead has received Food and Drug Administration approval for placement in the left bundle branch area of the heart.
- The lead connects to an implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator to treat abnormal heart rhythms.
- With left bundle branch placement, the lead can be used for conduction system pacing, an approach designed to activate the heart’s natural electrical system. The expanded indication gives Medtronic the first defibrillation lead approved for left bundle branch placement, the company said Monday.
Dive Insight:
Medtronic received FDA approval for the OmniaSecure lead for placement within the right ventricle last year and launched the device commercially in the U.S. in January.
Conduction system pacing, an alternative to traditional right ventricular pacing, has the potential to more closely mimic the heart's natural conduction system.
"Conduction system pacing is a rapidly growing therapy for patients who need a pacemaker,” Trevor Cook, general manager of Medtronic’s defibrillation solutions business in the cardiac rhythm management unit, said in a statement. “Now, patients who require a defibrillator and pacing have an option that can safely deliver life-saving defibrillation therapy and activate the heart's natural electrical system to enable a more synchronous, physiologic pattern."
FDA approval for OmniaSecure was supported by data from the LEADR LBBAP trial, which demonstrated the lead's safety and effectiveness, Medtronic said.
