Healthcare Industry News:  Balloon catheter 

Devices Cardiology

 News Release - October 19, 2006

CryoCath enrolls first patient in U.S. AF trial

MONTREAL, Oct. 19 (HSMN NewsFeed) - CryoCath Technologies (TSX: CYT ), the global leader in cryotherapy products to treat cardiovascular disease, today announced the first patient has been enrolled and treated in its pivotal Investigational Device (IDE) STOP AF trial. The FDA approved trial is designed to demonstrate Arctic Front(TM)'s clinical and therapeutic effectiveness in treating Atrial Fibrillation (AF).

The patient was enrolled by Dr. Kevin Wheelan and treated at the Baylor Medical Center in Dallas, Texas. The procedure was considered an acute success. There were no safety concerns noted, including no reports of phrenic nerve injury, thrombosis, or stroke.

"We consider the enrollment and successful treatment of the first patient an important step forward," said Jean-Pierre Desmarais, CryoCath's Chief Scientific Officer. "We anticipate that the other centers participating in the trial will begin recruiting patients shortly and that the trial will continue to steadily proceed."

As many as 250 patients, randomized into two arms, will be enrolled to complete the trial. One cohort will receive cryoablation therapy with Arctic Front (the ablation arm); the other will receive currently prescribed drug therapies (the control arm). 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 if they do not show improvement.

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, 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.
Please address inquiries directly to the issuing company.

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