Medtronic receives FDA approval for new type of implantable defibrillator

Medtronic has received U.S. regulatory approval to sell a new implantable defibrillator that can be placed outside of the heart and veins to treat SCA — sudden cardiac arrest — an electrical problem with the heart caused by a dangerously fast heart rate or irregular rhythm.

The U.S. Food and Drug Administration approved the Aurora EV-ICD after a clinical trial found the implantable cardioverter defibrillator (ICD) 98.7% effective, with no major complications compared to traditional ICDs, Medtronic said this week.

The results, published in the New England Journal of Medicine, also found 92.6% of patients were free from major system or procedure-related complications that would lead to hospitalization, system revision or death.

"I do think this route represents a paradigm shift and opens the door for similar therapies," said Dr. Ranjit John, the division chief of cardiothoracic surgery at M Health Fairview who was not involved in the clinical trials.

The Aurora defibrillator "might draw more patients to benefit from these therapies."

The Aurora EV-ICD is implanted below the left armpit and the lead is placed under the sternum through a minimally invasive procedure.

"For Medtronic it's an important approval. It's a new market for them," said Scott Ward, former CEO of New Brighton-based Cardiovascular Systems Inc., which was sold to Abbott for $850 million in April. "It's an advancement for sure. Having these leads extravascular really does make a big difference."

One benefit of the new defibrillator is that it could offer treatment options for patients who would not be candidates for traditional ICDs, Ward said.

"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," said Dr. Alan Cheng, chief medical officer of the cardiac rhythm management business for Medtronic, which is based in Ireland but run out of Fridley.

He added it is half the size and has projections of 60% longer battery life than its major competitor.

That competitor is Boston Scientific's MRI S-ICD System, which the FDA approved in 2012 and up until now was the only product of its kind to be commercially available.

"They can gain market share from Boston [Scientific]," said Ward of the new Medtronic device.

In February Medtronic received CE Mark approval for use of Aurora in Europe.

Aurora will be commercially available in the U.S. on a limited basis in the coming weeks. Physicians who took part in the clinical study and have already been trained on the implant procedure will be the first to have access to the system.

Dr. Anish Amin of OhioHealth Physician Group Heart and Vascular in Columbus, Ohio, a principal investigator for the trial, said leads connected to the heart with standard ICDs can be prone to infection or breakage.

"Lead management winds up being a long-term problem," said Amin.