CRYOCATH PROVIDES UPDATE ON PIVOTAL AF STUDY
Montreal, Quebec, Canada - April 3, 2006 - CryoCath Technologies Inc. (TSX:CYT), the global leader in cryotherapy products to treat cardiovascular disease, announced today it intends to expand the feasibility stage of its STOP AF trial by enrolling an estimated 15 additional patients. This trial is assessing the Company’s proprietary Arctic Front catheter to treat Atrial Fibrillation (AF), the most prevalent cardiac arrhythmia affecting more than 2.2 million Americans.
In addition to Massachusetts General Hospital in Boston and Mayo Clinic in Rochester, Minnesota, patients in this expanded phase will be treated by Dr. Jim Irwin at St. Joseph’s Hospital in Tampa, Florida and by Dr. Christopher Cole at Memorial Hospital in Colorado Springs, Colorado, with the latest version of CryoCath’s Arctic Front. Arctic Front’s revised design incorporates a number of improvements implemented following the start of the feasibility stage, including two balloon sizes, based on physician feedback from clinical use in Europe and the USA. As a result of these collective changes, the FDA has requested more patients be treated prior to the start of the pivotal portion of the U.S. IDE trial.
“While we are prepared to commence the pivotal stage of the STOP AF trial, we nonetheless understand the FDA position to have absolute certainty as to this or any other product’s ultimate safety profile,” said CryoCath’s Chief Scientific Officer, Jean-Pierre Desmarais. “The Arctic Front version to be used on these additional patients, all of whom have already been identified and lined-up for treatment, is the same version that is in commercial use in Europe and is performing well in multiple centres.”
The beta-launch of Arctic Front in Europe continues to progress well. More than 100 procedures have been performed demonstrating promising safety and efficacy. Chronic success data on a substantial number of patients will be presented at the German Cardiac Congress in Mannheim, Germany from April 20-22.
Once the Company receives feedback from the FDA, anticipated in mid-April, it will have more information as to the expanded enrolment and additional insight into the timing and nature of the next steps required to initiate and ultimately complete the pivotal component of this IDE trial. The Company will provide another update regarding this trial during its next quarterly conference call in mid-May, 2006.
About Arctic Front
About Medtronic CryoCath
CryoCath – 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).
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