Medtronic’s OmniaSecure, the smallest ICD lead of its kind, linked to long-term durability
Medtronic’s OmniaSecure defibrillation lead, already associated with positive early outcomes, is projected to deliver long-term durability, according to a new analysis published in HeartRhythm.[1]
The device, which Medtronic describes as “the world's smallest transvenous defibrillation lead,” has a size of just 4.7 French. It was linked to a better-than-expected performance when researchers presented late-breaking data from the LEADR clinical trial at Heart Rhythm 2024. For this latest study, the same group used reliability modeling to project how the OmniaSecure defibrillation lead may perform up to 10 years following implantation.
“Transvenous defibrillation leads remain the Achilles heel in implantable cardioverter-defibrillator (ICD) systems because of potential lead failure, which may result in adverse outcomes for modern ICD patients who have greater comorbidities,” wrote lead author George H. Crossley, III, MD, director of the electrophysiology lab and cardiac research enterprise at Vanderbilt University Medical Center, and colleagues. “Thus, defibrillation leads with increased durability are needed.”
The reliability modeling used by Crossley et al. was specifically designed to simulate “millions of combinations” of different issues that can arise during use over the life of a defibrillation lead. Additional things were also taken into account, including the implantation technique, the lead’s design and even imaging data from select patients who received the OmniaSecure device.
“There are multiple reports of reliability modeling used retrospectively on commercialized defibrillation and pacing leads,” the group explained. “The validated model described here has been used previously to evaluate two commercialized defibrillation leads with known real-world performance. In each case, the model accurately projected the incidence and presentation of conductor fractures that occur in vivo.”
Overall, the OmniaSecure device was linked to a projected fracture-free survival rate of 98.2% after 10 years. This included a fracture-free survival rate of 97.9% in active adolescent patients, a group the researchers were especially interested in tracking.
“This cardiac lead reliability modeling analysis projects a robust 10-year fracture-free performance of the OmniaSecure lead, including within active populations that may uniquely benefit from a highly durable small-diameter defibrillation lead,” the team wrote.
This device has not yet been approved by the U.S. Food and Drug Administration. Additional research is already underway to test its performance in additional patient populations.
Medtronic funded this research. Read the full study in HeartRhythm, a Heart Rhythm Society journal.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.