Against Odds, CryoCor Gets Advisory Panel Nod

Two days after CryoCor got word that FDA was not satisfied with safety and efficacy data for the company’s Cryoablation System, the agency’s advisory panel recommended the device for approval. FDA is not required to follow the advice of its advisors, but it typically does. A final decision by FDA is expected in August.

San Diego-based CryoCor is seeking an approval for 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 is CryoCor’s second go-around with trying to gain approval for the Cryoablation System. FDA rejected the company’s application last year, prompting CryoCor to amend and resubmit in November 2006.

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