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Cryoballoon wins FDA and CE Mark approval

Posted by: James Walsh Updated: August 24, 2012 - 11:49 AM
Medtronic on Friday announced that its Arctic Front Advance Cardiac Cryoballoon has received both U.S. Food and Drug Administration approval and CE Mark for the treatment of paroxysmal atrial fibrillation (PAF) in the United States and in many European countries. Medtronic says it is the only cryoballoon system currently on the market worldwide and provides a more efficient approach to treating PAF than point-by-point, radiofrequency ablation.
 
Atrial fibrillation is the most common – and one of the most undertreated – heart rhythm disorders, affecting more than 7 million people worldwide. It is estimated that half of all diagnosed atrial fibrillation patients fail drug therapy. If left untreated, patients have up to a five times higher risk of stroke4 and an increased chance of developing heart failure. PAF is a type of atrial fibrillation in which irregular heartbeats in the upper chambers start and stop suddenly on their own, usually for minutes or days at a time.
 
Cryoballoon treatment involves a procedure that isolates the pulmonary vein, a source of erratic electrical signals that cause AF, using coolant rather than heat. Delivered through a catheter, Medtronic said its cryoballoon technology is minimally invasive and allows for faster procedure times than radio frequency ablation. Medtronic said that 73 percent of its cryoablation patients were free from atrial fibrillation at one year, a significant increase over drug therapy.
 
Arctic Front Advance features the new EvenCool Cryo Technology, which optimizes the delivery of coolant inside the balloon. As a result, the larger, more uniform cold surface reduces the effort needed to isolate the pulmonary veins, the target of most AF ablation procedures, and improves physicians’ ability to treat patients with complicated anatomies compared to the original Artic Front CryoAblation System.
 
That system has been used to treat approximately 35,000 patients in more than 400 medical centers in 25 countries, Medtronic said.
 
“With Arctic Front Advance, we are now able to more effectively treat a broader range of pulmonary vein anatomies with less effort, which can potentially reduce procedure times,” said Vivek Reddy, M.D., director of Electrophysiology Laboratories at The Mount Sinai Medical Center in New York.
 
For more information about Medtronic’s new cryoballoon system, go to:  http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1345482875552&lang=en_US
 
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