Medtronic
(NYSE: MDT)
today announced positive study results for its investigational OmniaSecure catheter-delivered defibrillation lead.
The system met its primary safety and effectiveness endpoints and exceeded prespecified performance goals in the LEADR pivotal trial. Medtronic presented results at Heart Rhythm Society’s 2024 meeting in Boston and published results in the journal Heart Rhythm.
Implantable cardioverter defibrillators (ICDs) provide life-saving cardiac interventions. However, the medtech giant aims to improve upon one area of weakness: the transvenous leads. Medtronic engineers designed the OmniaSecure defibrillation lead based on its SelectSecure Model 3830 pacing lead. The company says it’s the world’s smallest transvenous defibrillation lead at 4.7 French. That equals about the diameter of graphite in a wooden pencil.
LEADR, a prospective, multicenter global study assessed OmniaSecure in 675 patients. The trial included 45 sites across 17 countries in North America, Europe, Asia and Australia. It looked at the lead’s safety and effectiveness when placed at traditional locations in the right ventricle to achieve defibrillation, sensing, pacing and cardioversion in patients at risk of sudden cardiac 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 Dr. George H. Crossley, director of the electrophysiology lab and cardiac research enterprise, Vanderbilt University Medical Center, Nashville, Tennessee, 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.”
A look at the data from Medtronic
Medtronic reported 97.5% success in defibrillation testing conducted at device implantation in 119 patients. That exceeded the prespecified efficacy goal of 88%.
At six months, 97.1% (Kaplan-Meier estimate) of 657 patients with an implant attempt were free from lead-related major complications. Those include hospitalization, lead fracture, system revision, or death. The study exceeded the prespecified safety goal of 90%. Medtronic reported no lead-related major complications between six and 12 months.
Additionally, the lead demonstrated reliable performance with zero fractures through the average follow-up period. Medtronic’s in-vitro model accurately predicts lead reliability out to 10 years and applied that model within the study. It predicts a fracture-free survival of 99.9% at two years for OmniaSecure.
OmniaSecure also demonstrated a 97.9% implant success rate and stable electricals through 12 months. Nearly 12% of patients received appropriate therapy for dangerously fast ventricular arrhythmias. Anti-tachycardia pacing (ATP) terminated 74.9% of episodes, preventing a shock in 49 patients.
Medtronic plans to present more LEADR results in the coming months. The company also initiated another study assessing OmniaSecure when placed at the left bundle branch area in patients eligible for an ICD or left bundle branch-optimized cardiac resynchronization therapy (LOT-CRT). That study has already had its first implants conducted.
“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,” said Dr. Alan Cheng, chief medical officer for Medtronic’s Cardiac Rhythm Management business. “The LEADR study results are an encouraging step forward in achieving the goal of an even more reliable defibrillation lead for patients.”
