MONTREAL, Dec. 12 /PRNewswire-FirstCall/ - CryoCath Technologies Inc. , the global leader in cryotherapy products to treat cardiovascular disease, today announced twelve month follow up data from 15 patients treated during the feasibility stage of its STOP AF trial. This trial, now in its pivotal stage, is assessing the Company's proprietary Arctic Front(TM) catheter to treat Atrial Fibrillation (AF), the most prevalent cardiac arrhythmia affecting more than 2.2 million Americans.
A total of 33 patients were treated during the feasibility stage. At the six month mark, eleven of the original fifteen patients (73%) were AF free. Of the eleven, nine are AF free at twelve months and off anti-arrhythmic drugs (AAD's) and two did not show up for their one year visits. Of the four that were not AF free at six months, all are off AAD's at 12 months, suggesting their AF condition improved to the level that AAD treatment is no longer necessary.
"The twelve month data is encouraging and strongly suggests that we are creating permanent lesions, producing a significant clinical benefit, including, in the majority of cases, freedom of AF," said Jean-Pierre Desmarais, Chief Scientific Officer, CryoCath. "It is critical to note that those patients that were AF free at six months remained so at twelve months. This is the key result."
Of the remaining 18 patients from the feasibility stage, five have reached the six month mark and four of these are AF free and all five are off AAD's. Of the balance of thirteen patients, all have reached their three month follow up and are off AAD's.
To summarize the results, of all original fifteen patients that were AF free at six months, that attended their twelve month visit remain AF free; all original fifteen patients are off AAD's; and all of the remaining eighteen patients have similar freedom from AF levels at three and six months and all are off AAD's.
About Arctic Front
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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 300 patients in more than 18 centers.
About CryoCath
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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.
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 www.sedar.com under the heading Risks and Uncertainties in the Management's Discussion and Analysis section.
CryoCath Technologies Inc.CONTACT: visit our website at www.cryocath.com, or contact Michael Moore,Investor Relations, Phone: (416) 815-0700 ext. 241, Fax: (416) 815-0080,E-mail: mmoore@equicomgroup.com