Medtronic receives E.U. approval for key new defibrillator system

After years of research and development, medical technology giant Medtronic is planning to commercially launch a new extravascular defibrillator system the company hopes will impact patients with abnormal heart rhythms.

The company — based in Ireland but run from Fridley — announced on Friday it had received European Union approval of its Aurora EV-ICD (extravascular implantable cardioverter defibrillator) and Epsila EV defibrillation lead system.

The company said it anticipates approval in the U.S. for the system sometime within the first half of 2023.

The E.U. approval is a significant step forward for the company. It's also a significant step in treating cardiac heart rhythm disorders.

Each year, more than 356,000 Americans suffer from sudden cardiac arrest — an electrical problem with the organ caused by a dangerously fast heart rate — outside of a hospital setting, according to the American Heart Association.

Nearly 90% of out-of-hospital cardiac arrests are fatal, according to the AHA.

The market could be even higher since it would include people at risk for cardiac arrest.

People who survive cardiac arrest, or are at risk of having one, are candidates for implantable defibrillators that shock their hearts back into its normal rhythm. Sometimes, though, people with those cardioverter defibrillators — which typically are implanted in the chest and attached to thin wires that are threaded through veins and into the heart — are subject to health issues stemming from the wire's connection.

The thin wire can lead to long-term complications like narrowing, blockage or compression of a vein and risks of blood infections. The thin wire in Medtronic's new system, which the company says is a first of its kind, is placed outside the heart and veins under the breastbone, avoiding transvenous wires. The Aurora defibrillator is implanted below the left armpit.

"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," said Alan Cheng, chief medical officer of Medtronic's cardiac rhythm management business.

This past December in a SEC filing, Medtronic reported fiscal 2023 second quarter earnings of $2.7 billion for its cardiovascular segment, down from $2.82 billion for the same quarter in 2021. The company's cardiovascular segment includes implantable cardioverter defibrillators, thin wires and delivery systems. Specifically, the cardiac rhythm and heart failure division made $1.43 billion in the quarter.

Cardiovascular net sales for the most recent six-month period ending Oct. 28 were $5.5 billion, a 4% drop compared with the same period in 2021.