FDA Clears CryoCor’s Cryoablation Device
August 3, 2007 - CryoCor Inc., a medical device company focused on the treatment of cardiac arrhythmias, announced today that the FDA has granted pre-market approval (PMA) for its Cardiac Cryoablation System for the treatment of right atrial flutter, enabling CryoCor to target over 200,000 U.S. patients treating flutter with cryoablation annually.
Based on this approval, CryoCor intends to begin selling its cryoablation system in the United States 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. The Company has targeted an initial installed base of approximately 120 to 160 consoles by December 31, 2008, growing to approximately 300 consoles by 2010.
For more information: www.cryocor.com