CryoCor, a San Diego-based medical device company focused on the treatment of cardiac arrhythmias, reported that the U.S. Food and Drug Administration has granted pre-market approval (PMA) for its cardiac cryoablation system for the treatment of right atrial flutter.
CryoCor said it will implement a formal training program for clinical sites, as well as conduct a two-arm registry study of 650 patients collecting safety and long-term effectiveness data on the use of its cryoablation system as compared to approved radiofrequency catheters in the treatment of right atrial flutter. CryoCor reported that it does not anticipate significant difficulty in complying with the requirements of the registry study.
Based on the PMA, CryoCor intends to begin selling its cryoablation system in the U.S. over the next several months. The company will place an initial focus on console placement in high-volume ablation centers in the U.S. and is currently evaluating its sales and marketing requirements for this strategy.
CryoCor said it has targeted an initial installed base of approximately 120 to 160 consoles by December 31, 2008, growing to approximately 300 consoles by 2010.