Medtronic (NYSE:MDT) announced Friday that it has received the expected nods from U.S. and European regulators for the Arctic Front Advance Cardiac Cryoballoon to treat paroxymal atrial fibrillation.
Paroxymal atrial fibrillation is different from atrial fibrillation in that the irregular heartbeat happens occasionally with the heart returning to its normal rhythm. It is episodic and unpredictable, and can develop into full-fledged atrial fibrillation for some patients.
Medtronic‘s cryoballoon technique uses cooling technology instead of the more common method of heat through radio frequency ablation to treat the condition. Most RF ablation procedures target the pulmonary vein to treat atrial fibrillation. The process of targeting this vein is made easier through the Arctic Front Advance Cardiac Cryoballoon, the company said in a news release.
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“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 Dr. Vivek Reddy, director of Electrophysiology Laboratories at The Mount Sinai Medical Center in New York, in that news release.
The current product that won dual regulatory nods is part of Medtronic‘s Atrial Fibrillation Solutions Business, a small but growing segment. In the company’s first fiscal quarter that ended July 27, the AF business saw worldwide growth of 20 percent to $55 million compared with $48 million in the same quarter a year ago. The Arctic Front cryoballoon product, the previous version of the Arctic Front Advance product, helped drive that strong growth, the company said.
Medtronic won U.S. Food and Drug Administration approval for the world’s first Arctic Front cryoballoon product back in 2010.
