FDA News

CryoCath receives FDA approval to expand STOP AF trial to full cohort of patients

(March 28, 2007)--CryoCath Technologies in cryotherapy products to treat cardiovascular disease, announced it has received notification from the U.S. Food and Drug Administration (FDA) allowing the Company to expand its pivotal Investigational Device (IDE) STOP AF trial for Arctic Front(R) to the full cohort of patients in all 20 centers. The trial is designed to demonstrate Arctic Front's clinical and therapeutic effectiveness in treating paroxysmal Atrial Fibrillation (AF) when compared to traditional medical therapy.

"FDA approval for final and complete expansion of our STOP AF trial enables us to continue executing our enrolment strategy with a definitive outlook on centers and patients," said Jean-Pierre Desmarais, Chief Scientific
Officer. "We can now drive Arctic Front forward with the main focus being the execution of the trial in front of us.

"CryoCath recently discovered a small one time packaging issue with FlexCath steerable sheath units, an access system used in conjunction with Arctic Front to aid in deploying it to targeted pulmonary veins. The Company
has initiated a voluntary product removal from the clinical centers, since corrected the issue and is working closely with FDA to ensure the corrective measures are reviewed and approved. It is believed that this review will have minimal impact on the study. To date, we have been very satisfied with our ability to start up centers and their corresponding ability to enroll patients in this landmark trial. Based on this experience, the  Company believes we can complete enrolment by the end of 2007.

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