BOSTON– An investigative small-diameter defibrillation lead for implantable cardioverter-defibrillators has actually surpassed its security and effectiveness expectations in a critical scientific trial.
The LEADR trial implanted OmniaSecure leads in 643 clients. It discovered that nearly 98% of the speculative leads were effectively implanted, and 99.5% were put specifically in the preferred area in the ideal ventricle.
Around 97% of clients had no lead-related significant issues in the 12 months of the research study, and none of the leads fractured throughout the research study duration, George H. Crossley III, MD, of Vanderbilt University Medical Center in Nashville, Tennessee, reported at the Heart Rhythm Society (HRS) 2024 conference. The outcomes were released concurrently in the journal Heart Rhythm
“The huge point here is that this is a brand-new method to developing a brand-new defibrillator lead by taking an actually robust pacemaker lead and altering the insulation,” Crossley stated in an interview. Those modifications make the catheter more versatile so the operator can provide the lead much faster and with more accurate positioning, he stated.
The OmniaSecure lead, made by medical gadget maker Medtronic, works with lots of commercially readily available catheters. It’s based upon Medtronic’s SelectSecure Model 3830 pacing lead, which has actually remained in usage given that 2003. Both leads have a taxi