CryoCath to Expand Enrollment in Atrial Fibrillation Device Trial

CryoCath Technologies announced the FDA is allowing it to expand its investigational device trial of its Arctic Front to the full cohort of patients in 20 centers. The trial is designed to demonstrate the Arctic Front's clinical and therapeutic effectiveness in treating paroxysmal atrial fibrillation versus traditional medical therapy.

The company recently issued a voluntary product removal from the study centers after discovering a "small, one-time packaging issue" with FlexCath steerable sheath units, used in conjunction with the Arctic Front to aid in deploying it to targeted pulmonary veins.

CryoCath says it has corrected the issue and is working with the FDA to ensure the corrective measures are reviewed and approved.

This review will have minimal impact on the study, the company said, adding that it believes it can complete enrollment by the end of 2007.