Medtronic Unveils Two Pivotal Clinical Studies on Defibrillation Innovations at APHRS 2025

Medtronic inTwo items were announced at the APHRS2025 conference regardingDefibrillationLatest BreakthroughClinical Research.

One is about extravascular defibrillators.Aurora EV-ICDReal-world Study (Enlighten Study），Research showsAurora EV-ICDDemonstrating a high success rate of anti-tachycardia pacing, effective defibrillation, a lower incidence of system-related chronic major complications, and a reduced rate of inappropriate shocks.

Another item is about the minimumDefibrillation LeadsOmniaSecure'sKey Trial (LEADR), Studies have shownFurther confirming the safety, efficacy, and reliability of the smallest-diameter OmniaSecure defibrillation lead when used in conjunction with traditional transvenous implantable cardioverter-defibrillators or cardiac resynchronization therapy defibrillators.

Executive Evaluation

"ICD is the cornerstone for preventing sudden cardiac death in millions of people, but the needs of each patient may vary. For most patients, Aurora EV-ICD can provide protection as it is the only ICD located outside the vascular space and capable of delivering ATP through a single device. For the remaining patients who require long-term pacing therapy, the 4.7 French, lumenless OmniaSecure lead, built for reliability, provides protection when connected to a transvenous ICD or CRT-D," it was noted. "These technological innovations are revolutionizing the patient experience while protecting them from the threat of this fatal condition."

---Trevor Cook Vice President and General Manager of Defibrillation Solutions in the Cardiac Rhythm Management Business under Medtronic's Cardiovascular Portfolio

• Enlighten Study

Enlighten is a real-world study, which included786 patients from 23 countries.

Specific Research Data (6 Months Post-Operative):

• High ATP Success Rate and Effective Defibrillation: ATP terminates ventricular tachycardia and restores the heart's normal rhythm by sending pacing pulses to the heart without the need for electric shocks. This technology successfully helped 17 patients avoid 44 electric shocks, with a termination rate consistent with the results of pivotal trials for transvenous ICDs and EV-ICDs.

• Aurora EV-ICD Demonstrates High Safety and Low Complication Rates: 97.8% of Patients Free from System-Related Chronic Major Complications Within Six Months, and 100% of Spontaneous Fatal Arrhythmia Events Successfully Treated.

• Compared with the pivotal EV-ICD trial before commercialization, the proportion of patients experiencing inappropriate shocks decreased by 32%.

Aurora EV-ICD is the world's first commercially available extravascular defibrillator (already launched in China) equipped with ATP therapy. By placing the lead under the sternum, outside the heart and veins, it provides the same life-saving benefits as traditional transvenous ICDs, with a device size, shape, and expected lifespan similar to those of conventional transvenous ICDs.Aurora EV-ICDEquipped with Smart Sense technology, which can reduce cardiac oversensing, one of the most common causes of inappropriate shocks.

PI Evaluation

"The robust safety and consistent performance of the Aurora EV-ICD in real-world settings further confirm the benefits experienced by patients using this extravascular defibrillator, which can prevent unnecessary shocks," said Ian Crozier, MD, a cardiologist at Christchurch Hospital in Christchurch, New Zealand, who presented the Enlighten data at the meeting. "These real-world results validate the findings observed in pivotal trials, showing high defibrillation and ATP success rates, low rates of system-related major complications, and reduced inappropriate shock rates compared to the pivotal trial. We look forward to following these patients for up to five years."

---Ian Crozier  Christchurch Hospital

• LEADR Study

LEADR is aProspective, multicenter clinical study, inA total of 675 patients were recruited across 45 centers in 17 countries in North America, Europe, Asia, and Australia. The product has already been launched in the United States.For implantation in the conventional position of the right ventricle. Currently under development.In the LEADR LBBAP study (aimed atEvaluate the Effect of Left Bundle Branch Area Pacing for Physiological Pacing）。

Specific Research Data (Three Years Post-Operation)

• OmniaSecureHigh defibrillation success rate demonstrated at implantation and during up to three years of dynamic follow-up

• Low risk of complications, with 96.5% of patients not experiencing major complications related to OmniaSecure.

• OmniaSecure demonstrated reliable performance with a high ATP success rate, appropriate shock therapy delivered to 22.3% of patients with indicated conditions, and stable electrical performance.

• OmniaSecureDemonstrates high reliability, with a zero-breakage rate consistent with the predicted 10-year 98.2% reliability model.