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News CryoCath enrolls first patient in U.S. AF trialMontreal, Quebec, Canada - October 19, 2006 - 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 Frontä’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
About Atrial Fibrillation
About Medtronic CryoCathCryoCath - www.cryocath.com - 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). For further information, please contact:
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