FDA approves Medtronic’s Arctic Front therapy for a-fib

Medtronic Inc. (NYSE:MDT) said Friday that the Food and Drug Administration (FDA) has approved a catheter-based therapy that uses cold temperatures to combat atrial fibrillation (AF).

The medical device giant, based in Fridley, Minnesota, said its Arctic Front system is the first FDA-approved technology in the United States to freeze diseased tissue that causes irregular heartbeats or quivering of the heart.

“This technology represents a significant improvement over currently used focal ablation treatment for atrial fibrillation,” Dr. Vivek Reddy, director of Electrophysiology Laboratories at Mount Sinai Medical Center, said in a statement. “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.”

Medtronic is essentially doubling down on the estimated $2 billion global AF market by developing technologies based on radio energy and subzero temperatures.

Medtronic inherited Arctic Front in 2008 when it paid $380 million to purchase CryoCath Technologies Inc. The Canadian company makes catheters (tubes) and balloons that restore normal electrical signals in the heart by freezing the tissue or pathways behind the irregular quivering.

“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,” Reggie Groves, vice president and general manager of Medtronic’s AF Solutions division, said in a statement.

In August, Medtronic won approval from Canadian regulators to sell a system originally developed by U.S.-based Ablation Frontiers Inc. to treat AF with radio frequencies.

About 2.2 million Americans suffer from AF, in which the two small upper chambers of the heart quiver instead of beat normally, according to the American Heart Association. When the patient’s heart is not pumping effectively, blood pools clot and get lodged in the brain, causing strokes.