Medtronic has released new data backing its Aurora and OmniaSecure implantable defibrillation technologies. The results were presented from two late-breaking presentations at the Asia Pacific Heart Rhythm Society (APHRS) Scientific Session 2025 held in Yokohama, Japan.

Six-month results from the Enlighten post-approval registry demonstrated success with the Aurora extravascular implantable cardioverter defibrillator (EV-ICD) and three-year results from the LEADR trial reinforced the safety, efficacy, and reliability of Medtronic’s OmniaSecure defibrillation lead.

The Enlighten study showed the Aurora EV-ICD had high anti-tachycardia pacing (ATP) success and effective defibrillation in a single device positioned outside the vascular space in a real-world population. The system also demonstrated a low rate of chronic major system-related complications and a lower shock rate.

The LEADR (Lead Evaluation for Defibrillation and Reliability) pivotal trial assessed the small-diameter OmniaSecure lead in traditional right ventricle locations. It examined OmniaSecure used with a transvenous ICD or cardiac resynchronization therapy defibrillators (CRT-Ds) like Medtronic’s Cobalt and Crome family of ICDs/CRT-Ds.

“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, Defibrillation Solutions in Medtronic’s Cardiac Rhythm Management business. “ For the majority of patients, the Aurora EV-ICD offers protection as the only ICD positioned outside the vascular space that also provides ATP in a single device.  For the remainder of patients who require chronic pacing therapy, the 4.7 French, lumenless, OmniaSecure lead built for reliability can offer protection when connected to a transvenous ICD or CRT-D,” These technological innovations are revolutionizing the patient experience while protecting them from this deadly condition.”

Medtronic’s Aurora EV-ICD data

These results were collected from 786 patients in 23 countries using the Aurora EV-ICD. It showed high ATP success—ATP delivers pacing pulses to the heart to terminate ventricular tachycardia and restore normal heart rhythm without a shock. It successfully avoided 44 shocks in 17 patients with a 67% termination rate, in line with transvenous ICDs and the EV-ICD pivotal trial.

The system was found safe with 97.8% of patients free from chronic major system-related complication through six months. 100% of spontaneous lethal arrhythmic episodes were effectively treated. Further, 32% fewer patients experienced an inappropriate shock compared to the premarket EV-ICD pivotal trial.

“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, M.D., cardiologist at Christchurch Hospital in Christchurch, New Zealand, who presented the Enlighten data at the meeting. “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.”

The Aurora EV-ICD won U.S. Food and Drug Administration (FDA) approval in 2023.

LEADR pivotal trial results

Data confirmed high defibrillation efficacy, safety, and reliability of the lumenless, small-diameter OmniaSecure defibrillation lead in traditional right ventricle locations. The lead connects to an ICD or CRT-D to treat life-threatening arrhythmias and is based on Medtronic’s SelectSure Model 3830 pacing lead.

The lead showed 97.5% defibrillation success at implant and 95.3% success in the ambulatory setting at three years. 96.5% of patients were free from a lead-related major complication.

OmniaSecure also demonstrated a 75.4% success rate of ATP and an appropriate shock delivery in 22.3% patients. It showed stable pacing thresholds, sensing amplitudes, and impedance as well. The lead was found to be highly reliable, with a fracture-free consistent with predicted 98.2% ten-year reliability modeling.

The OmniaSecure lead earned FDA approval to be placed in the right ventricle in April of this year.