Healthcare Industry News:  cryoablation 

Devices Cardiology FDA

 News Release - September 5, 2006

CryoCath receives FDA approval to start AF trial

MONTREAL, Sept. 5 (HSMN NewsFeed) - CryoCath Technologies Inc. (TSX: CYT ), the global leader in cryotherapy products to treat cardiovascular disease, today announced conditional approval by the U.S. Food and Drug Administration (FDA) for its STOP AF trial, allowing the Company to proceed to the pivotal stage of its Investigational Device Exemption ("IDE") trial for the Company's proprietary Arctic Front(TM) catheter to treat Atrial Fibrillation (AF).

Conditional approval allows CryoCath to start the trial at 5 centers enrolling up to 75 patients. Patients in the controlled trial will be randomized into two arms; one cohort receiving cryoablation therapy with Arctic Front (the ablation cohort); the other receiving currently prescribed drug therapies (the control cohort). For every two patients in the ablation arm, there will be one in the control arm. Patients in the trial will be highly symptomatic paroxysmal AF patients who have failed at least one anti-arrhythmic drug. The trial's primary endpoint will be the absence of detectable AF at the end of the 12-month follow-up period. The trial's design also allows patients randomized into the drug arm to cross-over into the ablation arm.

"We are very excited to begin the pivotal phase of the STOP AF trial which is designed to demonstrate Arctic Front's clinical and therapeutic advantages over current standard of care drug alternatives," said CryoCath's Chief Scientific Officer, Jean-Pierre Desmarais. "Moreover, we are confident the trial results will reflect the positive clinical experience with Arctic Front to treat AF we are seeing everyday in Europe."

Patient enrollment is expected to begin in the following weeks.

About Arctic Front

Arctic Front is a minimally invasive cryo-balloon catheter designed specifically to treat Atrial Fibrillation. This bi-directional, double balloon catheter enables physicians to rapidly isolate all four pulmonary veins for the treatment of AF. Approved in Europe under CE Mark, it has treated more than 250 patients in more than 15 centers.

About Atrial Fibrillation

AF, described as a rapid and chaotic quivering of the top two chambers in the heart, is the most prevalent arrhythmia, affecting more than 2 million patients in the U.S. with an annual incidence of 160,000 new cases per year. It is a leading cause of stroke and hospitalizations, and has become the most common complication of cardiovascular surgery. If left untreated, it can lead to heart failure and death.

About CryoCath

CryoCath - - is a medical technology company that leads the world in cryotherapy products to treat cardiovascular disease. With a priority focus on providing physicians with a complete solution of catheter and surgical products to treat cardiac arrhythmias, CryoCath has multiple products approved in the U.S., across Europe and several ROW countries. The Company is developing additional products to expand its pipeline of products to treat cardiac arrhythmias and has development projects for the treatment of cardiac ischemia (angina) and peripheral arterial disease (PAD).

This press release includes "forward-looking statements" that are subject to risks and uncertainties, including with respect to the timing of regulatory trials and their outcome. For information identifying legislative or regulatory, economic, climatic, currency, technological, competitive and other important factors that could cause actual results to differ materially from those anticipated in the forward looking statements, see CryoCath's annual report available at under the heading Risks and Uncertainties in the Management's Discussion and Analysis section.

Source: CryoCath Technologies

Issuer of this News Release is solely responsible for its content.
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