BOSTON — An investigative small-diameter defibrillation lead for implantable cardioverter-defibrillators has exceeded its safety and efficacy expectations in a pivotal clinical trial.
The LEADR trial implanted OmniaSecure leads in 643 patients. It found that almost 98% of the experimental leads were successfully implanted, and 99.5% were placed precisely in the desired location in the right ventricle.
Around 97% of patients had no lead-related major complications in the 12 months of the study, and none of the leads fractured during the study period, George H. Crossley III, MD, of Vanderbilt University Medical Center in Nashville, Tennessee, reported at the Heart Rhythm Society (HRS) 2024 meeting. The results were published simultaneously in the journal Heart Rhythm.
“The big point here is that this is a new approach to creating a new defibrillator lead by taking a really robust pacemaker lead and changing the insulation,” Crossley said in an interview. Those changes make the catheter more flexible so the operator can deliver the lead faster and with more precise placement, he said.
The OmniaSecure
