Medtronic gets FDA OK for cryoablation device

by Brendon Nafziger, DOTmed News Associate Editor | December 20, 2010
Medtronic Inc. said Friday it received U.S. Food and Drug Administration's approval for the first cryoablation balloon catheter for drug-refractory paroxysmal atrial fibrillation.

The device, dubbed the Arctic Front cardiac cryoablation catheter system, delivers coolant through a catheter to freeze and kill cells near the entrance to the pulmonary vein, the source of electric signals that cause the abnormal heartbeat in AF.

Most ablation catheters deliver radiofrequency heat to destroy the cells, but Medtronic said using coolant allows for greater catheter stability as cooling lets the balloon stick to the tissue during ablation.

"This technology represents a significant improvement over currently used focal ablation treatment for atrial fibrillation," said Dr. Vivek Reddy, director of Electrophysiology Laboratories at The Mount Sinai Medical Center in New York and a paid speaker for Medtronic, in prepared remarks.

The Minneapolis-based company said FDA's approval was largely based on the STOP AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) trial. In the study, about 70 percent of patients were paroxysmal atrial fibrillation-free one year after treatment, compared with only 7.3 percent of patients treated with drugs alone. The procedure-related adverse event rate was about 3 percent.

The cryoablation technology was developed by Montreal-based CryoCath Technologies Inc., which Medtronic bought two years ago in a deal valued at around $380 million.

Around 3 million Americans suffer from atrial fibrillation, according to Medtronic. Paroxysmal atrial fibrillation is a type of the disease in which brief episodes of irregular heartbeats in the heart's upper chambers strike periodically.