FDA approves Medtronic's Arctic Front Cardiac CryoAblation Catheter system for drug refractory PAF

Medtronic, Inc. (NYSE:MDT) today announced that the U.S. Food and Drug Administration (FDA) has approved its Arctic Front^® Cardiac CryoAblation Catheter system, the first and only Cryoballoon in the United States indicated for the treatment of drug refractory paroxysmal atrial fibrillation (PAF). The Cryoballoon treatment involves a minimally-invasive procedure that efficiently creates circumferential lesions around the pulmonary vein, which is the source of erratic electrical signals that cause the irregular heartbeat.

“We are now able to offer this novel technology, which has already been used to treat more than 10,000 patients in more than 200 centers outside of the U.S., to physicians and patients in this country.”

Balloon-based technology is novel because it ablates or blocks the conduction of atrial fibrillation (AF) in cardiac tissue through the use of a coolant rather than heat, which is delivered through a catheter. This freezing technology allows the catheter to adhere to the tissue during ablation, allowing for greater catheter stability.

"This technology represents a significant improvement over currently used focal ablation treatment for atrial fibrillation," said Vivek Reddy, MD, director of Electrophysiology Laboratories at The Mount Sinai Medical Center in New York, NY. "This unique ablation approach fills an unmet need in AF ablation by providing a straightforward and efficient approach to pulmonary vein isolation, while giving patients a new, minimally-invasive treatment approach proven to be safe and effective."

The FDA approval of the Arctic Front System was based on the pivotal STOP AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) trial, which demonstrated the safety and efficacy of the device in treating and eradicating paroxysmal atrial fibrillation. The study showed that 69.9 percent of patients treated with Arctic Front were free from atrial fibrillation at one year, compared to 7.3 percent of patients treated with drug therapy only. The study also demonstrated that treatment with the device is safe, with limited procedure-related adverse events (3.1 percent), and patients enrolled in the study displayed a significant reduction of symptoms, a decrease in the use of drug therapy and substantial improvements in both physical and mental quality-of-life factors.

"This next-generation technology demonstrates Medtronic's commitment to providing physicians with innovative solutions proven to help them efficiently, effectively and safely treat patients suffering from Atrial Fibrillation," said Reggie Groves, vice president and general manager of Medtronic's AF Solutions division. "We are now able to offer this novel technology, which has already been used to treat more than 10,000 patients in more than 200 centers outside of the U.S., to physicians and patients in this country."

Medtronic acquired U.S.-based Ablation Frontiers, Inc., and Montreal-based CryoCath Technologies, Inc. to form Medtronic's AF Solutions division within the Cardiac Rhythm Disease Management business. When combined with Medtronic's existing EP Systems product portfolio, AF Solutions offers an extensive line of diagnostic, cryoablation (freezing technology) and radiofrequency ablation tools to diagnose and treat a broad spectrum of cardiac arrhythmias.

SOURCE Medtronic, Inc.