Medtronic’s Investigational ICD Lead Achieves Primary Study Endpoints

Medtronic released favorable study results for its investigational OmniaSecure defibrillation lead at Heart Rhythm 2024.
 
OmniaSecure met primary safety and effectiveness endpoints, exceeding performance goals in the global, prospective, multicenter Lead Evaluation for Defibrillation and Reliability (LEADR) pivotal trial. In addition to presentation at Heart Rhythm 2024, the results were published in the Heart Rhythm journal.
 
Implantable cardioverter-defibrillators (ICDs) are used to prevent sudden cardiac death. Medtronic hopes to improve upon the devices’ current weakness, the transvenous leads. The OmniaSecure lead is based on the company’s over 20-year legacy SelectSure Model 3830 pacing lead. Medtronic said OmniaSecure is also the world’s smallest pacing lead, measuring the diameter of graphite in a wooden pencil.
 
The LEADR trial enrolled 675 patients at 45 sites in 17 countries across North America, Europe, Asia, and Australia. It assessed the OmniaSecure lead’s safety and effectiveness when place in traditional locations in the right ventricle for defibrillation, sensing, pacing, and cardioversion in patients at risk of sudden death.
 
“The positive results from the LEADR Pivotal trial are a significant advancement for patients at risk of sudden cardiac death who rely on ICDs to deliver life-saving therapy in the event of a dangerous heart rhythm,” said George H. Crossley, M.D., Director of the Electrophysiology Lab and Cardiac Research Enterprise, Vanderbilt University Medical Center, Nashville, Tenn., and LEADR Pivotal trial steering committee chair. “Patients with defibrillators are living longer today, and we need to strive for reliable therapy for the lifetime of the patient. This innovative, low-profile defibrillation lead leverages a highly reliable pacing lead design to help achieve this goal, and the unique catheter-based method of implantation helps the physician place the lead in the optimal position for the patient.”

More about Medtronic’s LEADR pivotal trial data

The company reported 97.5% case success for defibrillation testing conducted at implantation in 119 patients, surmounting the prespecified 88% efficacy goal.
 
At six months, 97.1% (Kaplan-Meier estimate) of 657 patients with an implant did not have lead-related major complications. The study rose above the prespecified safety performance goal of 90%. There were no lead-related major complications seen between six and 12 months (average follow up of 12.7±4.8 months).
 
The OmniaSecure lead also showed reliable performance with no study lead fractures through 12 months. Medtronic developed and validated an in-vitro model that predicts lead reliability out to 10 years, the company said.
 
Almost 12% of trial patients received anti-tachycardia pacing (ATP) for dangerously fast ventricular arrhythmias through 14 months, preventing a shock in 49 patients. Medtronic said it will present further reliability model results from the LEADR study in the coming months.

The company also announced it began the Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP) study to examine the OmniaSure lead when placed at the left bundle arch area in patients eligible for an ICD or left bundle branch-optimized cardiac resynchronization therapy (LOT-CRT). The first implants in this study were recently done.
 
“For 75 years, Medtronic has innovated to bring better life-saving technologies to the patients who need them,” said Alan Cheng, M.D., chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic. “Given our history in working with health care providers to design technology for patients with arrhythmias, we applied learnings from our deep experience with both transvenous defibrillation and pacing leads to create the novel OmniaSecure lead, a catheter-delivered lead that can be placed in the desired location. The LEADR study results are an encouraging step forward in achieving the goal of an even more reliable defibrillation lead for patients.”