The FDA granted approval for the Aurora system and the Epsila EV MRI SureScan defibrillation lead. They treat dangerously fast heart rhythms that can lead to sudden cardiac arrest (SCA). Medtronic says Aurora EV-ICD is the first to provide the benefits of traditional, transvenous ICDs — with a lead placed under the breastbone and outside the heart and veins.
Aurora delivers defibrillation, anti-tachycardia pacing (ATP) and backup (pause-prevention) pacing therapies. It’s still a device similar in size, shape and longevity to traditional transvenous ICDs.
Medtronic said the FDA approval includes the Aurora system’s proprietary procedure implant tools. Global pivotal trial results demonstrating the system’s safety and effectiveness supported the approval. The company plans to begin a limited launch in the U.S. in the coming weeks.
“This FDA approval paves the way for patients to have a better overall experience with ICD therapy,” said Dr. Alan Cheng, chief medical officer of the Cardiac Rhythm Management business at Medtronic. “ICDs remain the gold standard for prevention of sudden cardiac death, and while the subcutaneous ICD avoids certain complications associated with transvenous defibrillators, it has limitations that may affect a patient’s comfort and quality of life. With the Aurora EV-ICD system, patients can benefit from the only ICD placed outside the vascular space that provides ATP and backup pacing, in a device that is nearly half the size and with 60% greater projected battery longevity compared to the competitor’s subcutaneous ICD.”
More about the Medtronic Aurora EV-ICD
Traditional ICD implants typically take place below the collarbone with leads threaded through the veins and into the heart. Medtronic designed its system to offer an alternative.
Features include ATP using low-energy pacing pulses, potentially avoiding a defibrillation shock. Aurora’s pause prevention pacing provides backup pacing for brief, intermittent heartbeat pauses. The system’s 40 Joule energy delivers life-saving shocks in a device the size of transvenous ICDs.
Medtronic developed the system with its PhysioCurve design to increase patient comfort and implant acceptance. It has an 11.7-year projected longevity to reduce device replacement procedures during a patient’s lifetime. Patients who receive the Aurora device can also benefit from Smart Sense, a proprietary algorithm designed to reduce the potential for inappropriate shocks.
In Medtronic’s pivotal study, the device produced an effectiveness of 98.7% with no major intraprocedural complications. Additionally, the study saw 33 defibrillation shocks avoided by having ATP. At six months, 92.6% of patients were free from major system and/or procedure-related complications.
Medtronic plans to obtain real-world performance and safety data in a post-approval registry over about five years.
“The Aurora EV-ICD system is a tremendous step forward in implantable defibrillator technology,” said Dr. Bradley P. Knight, medical director of Electrophysiology at Northwestern Medicine Bluhm Cardiovascular Institute and a co-author of the study. “Placing the leads outside of the heart, rather than inside the heart and veins, reduces the risk of long-term complications, ultimately allowing us to further evolve safe and effective ICD technology.”
