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CryoCor Delays Filing Device Application

By: Ed Kensik

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San Diego, CA-based CryoCor reported that it has delayed the filing of an amendment to its application for its atrial flutter treatment to the end of November, according to the Associated Press.

The manufacturer of disposable catheter systems to treat dangerous cardiac arrhythmias received a letter from the FDA in February stating that data for the company’s cardiac cryoablation system did not meet the agency’s chronic efficacy criteria. The company previously anticipated submitting the amendment to the FDA in the third quarter.

“This is an important filing for CryoCor and we have thoroughly reviewed the safety and effectiveness data from our AFL pivotal study,” said CEO Ed Brennan in a statement. “We believe the additional time will allow us to provide supplementary information to these data.”

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