Cardiac Cryoablation System Treats Right Atrial Flutter

The system consists of four integrated components: The command center cryoablation console, an articulating arm with an attached pre-cooler, the cryoablation catheter, and a vascular sheath introducer. The steerable 10 French cryoablation catheter incorporates an integrated articulation lever and a locking brake that facilitate precise placement and easy fingertip control. The system has been has been granted pre-market approval (PMA) by the U.S. Food and Drug Administration (FDA) for the treatment of right atrial flutter.

The cryoablation system, a product of CryoCor (San Diego, CA, USA), was granted the PMA by the FDA under two conditions: that the company implement a formal training program for clinical sites, and also conduct a two-arm registry study of 650 patients collecting safety and long term effectiveness data on the use of the cryoablation system as compared to approved radiofrequency catheters in the treatment of right atrial flutter.

"I am extremely pleased with the FDA's decision to approve our Cryoablation System for the treatment of right atrial flutter. There is a large opportunity for treating flutter with cryoablation,” said Helen Barold, M.D., chief medical officer of CryoCor. "Over 200,000 patients per year in the United States are diagnosed with this condition. Many of these patients could benefit from the unique advantages provided by our system, specifically the fact that cryoablation is a less painful way of ablating right atrial flutter.”


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