Medtronic last week announced that its OmniaSecure™ defibrillation lead met primary safety and effectiveness endpoints, exceeding performance goals, in the Lead Evaluation for Defibrillation and Reliability (LEADR) Pivotal trial.
The OmniaSecure defibrillation lead is investigational and has not yet been approved for sale or distribution. The study's results were presented at Heart Rhythm 2024 and published in the Heart Rhythm journal.
Implantable cardioverter defibrillators (ICDs) are the gold standard for preventing sudden cardiac death. Yet transvenous defibrillator leads, which are thin wires connected to the ICD and threaded through the veins into the heart muscle, remain the system's weakest point [1].
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The human body is a harsh environment in which the lead must remain attached and yet flex with millions of heart contractions over a patient's lifetime. Existing defibrillation leads have a large diameter (7-8 French), which can contribute to venous occlusion or tricuspid valve complications.
For patients where an extravascular defibrillator may not be appropriate, Medtronic engineers designed the OmniaSecure defibrillation lead based on the Medtronic SelectSecure™ Model 3830 pacing lead, which has offered safe and effective treatment to patients for more than 20 years.
By beginning with this pacing lead and building a larger lead suitable for defibrillation therapy, the OmniaSecure lead is the world's smallest transvenous defibrillation lead (4.7 French, about the diameter of graphite in a wooden pencil).
Defibrillation testing conducted at device implantation in 119 patients was successful in 97.5% of cases. The study 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, like hospitalization, lead fracture, system revision, or death. The study exceeded the prespecified safety performance goal of 90%. No lead-related major complications were observed between six and 12 months (average follow-up of 12.7±4.8 months).
In a statement, George Crossley, M.D., Director of the Electrophysiology Lab and Cardiac Research Enterprise at the Vanderbilt University Medical Center in Nashville, Tennessee, and LEADR Pivotal trial steering committee chair, said, "Patients with defibrillators are living longer today, and we need to strive for reliable therapy for the lifetime of the patient."
The LEADR Pivotal trial is a prospective, multicenter, single-arm, non-randomized, global clinical study that assessed the safety and effectiveness of the Medtronic OmniaSecure defibrillation lead 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 study enrolled 675 patients at 45 sites in 17 countries in North America, Europe, Asia, and Australia.
The lead demonstrated reliable performance with zero (0) study lead fractures through an average follow-up of 12.7±4.8 months. Medtronic developed and validated an in-vitro model that accurately predicts lead reliability out to 10 years [2] and then applied that model within the study to predict a fracture-free survival of 99.9% at two years for the investigational OmniaSecure lead.
The lead also demonstrated a 97.9% implant success rate and stable electricals (R-wave, pacing capture threshold, and pacing impedance) through 12 months.
Nearly 12% of patients in the study received appropriate therapy (shock or anti-tachycardia pacing [ATP]) for dangerously fast ventricular arrhythmias by 14.0±5.0 months. ATP terminated 74.9% of episodes, preventing a shock in 49 patients.
Medtronic will present additional results from the LEADR study in the coming months.
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- Swerdlow CD, Kalahasty G, Ellenbogen KA. Implantable Cardiac Defibrillator Lead Failure and Management. J Am Coll Cardiol 2016;67:1358-1368
- Wilkoff, Bruce L., et al. In vitro modeling accurately predicts cardiac lead fracture at 10 years. Heart Rhythm 18.9 (2021): 1605-1612.
