Medtronic wins CE mark for extravascular defibrillator system

Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Aurora EV-ICD and Epsila EV MRI SureScan system.

The Aurora EV-ICD and Epsila EV defibrillation lead treat dangerously fast heart rhythms that can lead to sudden cardiac arrest. The EV-ICD (extravascular implantable cardioverter-defibrillator) system offers the live-saving benefits of traditional ICDs. However, it avoid certain risk with its lead placed outside the heart and veins.

Aurora remains investigational in the U.S. Medtronic plans to make it commercially available in select European countries in autumn 2023.

Patients who receive the Aurora EV-ICD system have defibrillation, anti-tachycardia pacing (ATP) and back-up pacing therapies available through a single implanted device. The device offers similar size, shape and longevity to traditional ICDs, Medtronic said. It also features proprietary procedure implant tools.

More about the Medtronic Aurora EV-ICD

Medtronic said patients receive the Aurora EV-ICD implant below the left armpit. The Epsila EV lead is placed under the sternum using a minimally invasive approach. It helps avoid long-term complications that may be associated with transvenous leads, the company said. These include vessel occlusion and risks for blood infection.

The company received European approval following a pivotal study of the EV-ICD. The study met its safety and effectiveness endpoints. Medtronic said the device’s effectiveness in delivering defibrillation therapy at implant registered at 98.7%. Meanwhile, 92.6% of patients proved free from major system and/or procedure-related complications. No patients experienced major intraprocedural complications or unique complications related to the EV-ICD.

Medtronic’s Aurora EV-ICD received an indication for patients at risk of life-threatening arrhythmias. These patients have not had a prior sternotomy and don’t require chronic bradycardia pacing.

“We are proud to be the first company to offer a complete one-system, one-procedure extravascular ICD solution, which maintains the patient benefits of traditional, transvenous ICDs without the risk of leads in the heart and vasculature,” said Dr. Alan Cheng, CMO of the Cardiac Rhythm Management business at Medtronic. “This approval is a significant milestone in achieving our goal of delivering a defibrillation solution that treats sudden cardiac arrest while improving the patient experience.”

Original Article: (https://www.massdevice.com/medtronic-ce-mark-extravascular-defibrillator-system/)