FDA Approves CryoCor’s Atrial-Flutter Device

After a roller-coaster approval process, San Diego-based CryoCor (CRYO) has at last received FDA’s okay for its Cryoablation System, which uses extreme cold to treat cardiac arrhythmias.

The device was approved for the treatment of right atrial flutter, a condition where the upper chambers of the heart beat too fast. Unlike other devices on the market that use heat to treat atrial flutter, the Cryoablation System uses extreme cold to destroy damaged cardiac tissue. This videoshows how it works.

For CryCor, the approval comes after a somewhat tumultuous wait. 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.

Finally armed with an approval, CryoCor intends to begin selling the Cryoablation System in the U.S. over the next several months. 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.