Medtronic has announced the recent presentation of results from two late-breaking studies at the 2025 Asia Pacific Heart Rhythm Society (APHRS) Scientific Sessions (12–15 November, Yokohama, Japan), including six-month results from the Enlighten study—a post-approval registry of the company’s Aurora extravascular implantable cardioverter-defibrillator (EV-ICD)—and final three-year results from the LEADR pivotal trial evaluating the OmniaSecure defibrillation lead.
“ICDs are the cornerstone for preventing sudden cardiac death for millions of people, but each patient’s needs may be different,” said Trevor Cook, vice president and general manager of defibrillation solutions within the Cardiac Rhythm Management business, which is part of Medtronic’s Cardiovascular Portfolio. “For the majority of patients, the Aurora EV-ICD offers protection as the only ICD positioned outside the vascular space that also provides ATP [anti-tachycardia pacing] in a single device. For the remainder of patients who require chronic pacing therapy, the 4.7Fr lumenless OmniaSecure lead built for reliability can offer protection when connected to a transvenous ICD or CRT-D [cardiac resynchronisation therapy defibrillator]. These technological innovations are revolutionising the patient experience while protecting them from this deadly condition.”
Six-month results from the Enlighten study of 786 patients across 23 countries demonstrated that the Aurora EV-ICD had high ATP success and effective defibrillation in a single device positioned safely outside the vascular space in a real-world population. ATP successfully avoided 44 shocks in 17 patients with a termination rate (67%) in line with transvenous ICDs and with the EV-ICD pivotal trial, according to Medtronic. Additionally, the system was found to be safe with a low risk of complications, showing 97.8% of patients were free from a chronic major system-related complication through six months, and 100% of spontaneous lethal arrhythmic episodes were effectively treated. Furthermore, performance of the commercial device saw an improvement, as 32% fewer patients experienced an inappropriate shock compared to in the premarket EV-ICD pivotal trial (5.5% vs 8.1% at six months, respectively).
The Aurora EV-ICD system is described by the company as a “first-of-its-kind” extravascular defibrillator with ATP therapy to provide the life-saving benefits of traditional, transvenous ICDs with a lead placed under the sternum, outside of the heart and veins, via a device that is similar in size, shape and projected longevity versus traditional transvenous ICDs. The device is equipped with Smart Sense technology that reduces cardiac oversensing, one of the most common reasons for inappropriate shocks, Medtronic also claims.
“The strong safety profile and consistent performance of the Aurora EV-ICD in real-world settings reinforces the benefit that patients are experiencing with a defibrillator outside of the vasculature that avoids unnecessary shocks,” said Ian Crozier (Christchurch Hospital, Christchurch, New Zealand), who presented the Enlighten data at APHRS 2025. “These real-world outcomes confirm the results observed in the pivotal trial showing high defibrillation and ATP success, a low system-related major complication rate, and a reduced rate of inappropriate shocks compared to the pivotal trial. We look forward to continued follow-up of these patients out to five years.”
As also recently announced by Medtronic, the final three-year results from the LEADR pivotal trial have reinforced the safety, reliability and high defibrillation efficacy of the lumenless, small-diameter OmniaSecure defibrillation lead used in traditional locations within the right ventricle—and with traditional transvenous ICDs or CRT-Ds like the company’s Cobalt and Crome families of ICDs/CRT-Ds. The prospective, multicentre LEADR pivotal trial enrolled 675 patients at 45 sites in 17 countries across North America, Europe, Asia, and Australia.
The OmniaSecure lead demonstrated high defibrillation success at implant (97.5%), and in the ambulatory setting through three years (95.3%). There was a low risk of complications, with 96.5% of patients free from an OmniaSecure lead-related major complication, and the lead also exhibited reliable performance with a high ATP success rate (75.4%), an appropriate shock delivery in 22.3% of patients, and stable electrical performance including stable pacing thresholds, sensing amplitudes, and impedance. Additionally, the lead has displayed high reliability with a fracture-free rate consistent with predicted 98.2% 10-year reliability modelling, according to Medtronic.
Medtronic says that its engineers designed the OmniaSecure defibrillation lead based on the company’s “highly durable” SelectSecure Model 3830 pacing lead, which has offered safe and effective treatment to patients for more than 20 years. OmniaSecure received US Food and Drug Administration (FDA) approval in April 2025 for traditional placement in the right ventricle and is being evaluated for placement in the left bundle branch area (LBBA) for physiologic pacing in the LEADR LBBAP trial—a usage that is currently investigational and will require separate regulatory approvals in the future.
