San Diego-based CryoCor has completed enrollment of the pivotal clinical study for using its Cryoabalation System to treat atrial fibrillation, bringing the company one step closer to its goal of U.S. approval for both a-fib and atrial flutter.
The Cryoabalation System, which uses extreme cold to destroy damaged cardiac tissue, was approved earlier this month for the treatment of right atrial flutter. That approval was a longtime coming: In June, the company learned that an FDA advisory panel was not convinced of the Cryoablation System’s longterm efficacy or safety profile, only to find out two days later that the panel had approved the device. The initial negative review in June was the second time FDA had found fault with CryoCor’s device. The agency rejected the company’s PMA application last year, prompting CryoCor to amend and resubmit in November 2006.
CryoCor intends to begin selling the Cryoablation System for the atrial flutter indication over the next several months in the U.S. The company will focus initially on console placement in high-volume ablation centers, a strategy for which it’s currently developing sales and marketing plans. CryoCor has targeted an initial installed base of approximately 120-160 consoles by the end of 2008, growing to approximately 300 consoles by 2010.
The Cryoabaltion System has been on the market in Europe for both atrial fibrillation and atrial flutter since 2002.
