Cryo Catheter Ablation System Approved for Treatment of Paroxysmal Atrial Fibrillation in the U.S.

By Mellanie True Hills

December 21, 2010 — The U.S. Food and Drug Administration (FDA) has approved Medtronic’s Arctic Front® Cardiac CryoAblation Catheter system for the treatment of paroxysmal atrial fibrillation. This is the first cryo (freezing) catheter ablation system to receive U.S. approval, and contains a traditional single-point catheter as well as a unique balloon catheter.

Approval was based on the results of the STOP AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) trial about which we previously reported. In STOP AF, almost 70 percent of patients treated with this cryoablation were free from atrial fibrillation at one year compared to about one-tenth as many on afib drugs. A subsequent analysis of STOP AF data showed a significant reduction in AF-related symptoms for those who had cryoablations, thus improving their quality-of-life.

Following approval, Medtronic’s AF Solutions vice president and general manager, Reggie Groves, said that this technology has treated more than 10,000 patients outside of the U.S. and is now available to U.S. patients.

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Comments: One of the most interesting and surprising aspects of this approval was the lack of an FDA Advisory Committee hearing as part of the process. In asking around to understand this, we heard speculation that the Advisory Committee was not necessary since another catheter ablation device had been approved previously. While this system includes a different energy source—freezing instead of heating— and has a first-of-a-kind device—the cryoballoon—it also has a single-point catheter like the already-approved single-point Biosense Webster THERMOCOOL irrigated catheter. Thus it could be that it was not a “new indication”, but was instead for the same treatment as a catheter that had been approved.

Could it also be possible that the track record in other countries—more than 10,000 procedures—may have influenced this? Perhaps.

What do you think—does this track record have implications for U.S. patients? Please share your thoughts and comments at the Atrial Fibrillation Blog.