Medtronic’s New Aurora EV-ICD Receives FDA Approval; Real World Performance Study Hopes to Show Lower Rates of Venous Complications
Medtronic has received approval from the U.S. Food and Drug Administration (FDA) for its new Aurora EV-ICD™ MRI SureScan™ (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV™ MRI SureScan™ defibrillation lead. The system is engineered to combat dangerously fast heart rhythms that can culminate in sudden cardiac arrest (SCA).
The Aurora EV-ICD system offers advantages of conventional, transvenous ICDs. Conventional ICDs are implanted below the collarbone, with leads threaded through the veins and into the heart, the Aurora EV-ICD system takes a distinctive approach. The Aurora EV-ICD system is placed beneath the left armpit (in the left mid-axillary region), and the lead is nestled beneath the breastbone using a minimally invasive technique. The Epsila EV defibrillation lead is sited outside the heart and veins, mitigating complications typically associated with transvenous leads, such as vascular injuries and vein occlusion. A study published in the Journal of the American College of Cardiology showed that venous complications occur in approximately one third of the one million patients who receive pacemakers in the U.S. every year. The lead can deliver defibrillation therapy, anti-tachycardia pacing (ATP), and back-up (pause-prevention) pacing therapies in a device that’s similar in size, shape, and longevity to traditional, transvenous ICDs.
Dr. Bradley P. Knight, the Medical Director of Electrophysiology at Northwestern Medicine Bluhm Cardiovascular Institute and one of the study’s co-authors stated. “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.”
The pivotal study, which paved the way for FDA approval, demonstrated that the Aurora EV-ICD system exhibited 98.7% effectiveness in delivering defibrillation therapy during implant. Moreover, it did not incur any major intraprocedural complications or any distinctive complications associated with the EV ICD procedure or system compared to transvenous and subcutaneous ICDs.
Medtronic plans to acquire real-world performance and safety data through the Enlighten global post-approval registry. This prospective, non-randomized, observational, multicenter study is set to last approximately five years and will enroll around 1,000 patients.