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CryoCath pivotal trial delayed

This article was originally published in The Gray Sheet

Executive Summary

FDA is requiring CryoCath to enroll 15 additional patients in its feasibility study for the Arctic Front cryoablation system to treat atrial fibrillation in order to assess design changes made to the catheter, firm announces April 3. The 15 additional patients have been identified and will be enrolled at two additional U.S. sites, accord-ing to CryoCath. Still, the pivotal stage of the STOP-AF trial, originally anticipated to begin in the second quarter, will likely be pushed back. Principle investigator Douglas Packer, MD, Mayo Clinic, announced in January that 13 of the initial 15 patients in the feasibility study were free of atrial fibrillation at three months (1"The Gray Sheet" Jan. 23, 2005, p. 9)...
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