MONTREAL, June 28 /PRNewswire-FirstCall/ - CryoCath Technologies Inc. , the global leader in cryotherapy products to treat cardiovascular disease, today announced that data on the Company's proprietary Arctic Front(R) catheter system to treat Atrial Fibrillation (AFib) was presented at the European Society of Cardiology (Europace) Conference in Lisbon, Portugal from June 24-27, 2007. Electrophysiologists from around the world attend this bi-annual conference to discuss cardiac arrhythmias.
On June 25, in a satellite symposium entitled "State of the Art Treatment of Atrial Fibrillation: The Arctic Front Cryoballoon Catheter," Dr. Heinz-Friedrich Pitschner from the Kerckhoff-Klinik in Bad Nauheim, Germany presented data from three centers on behalf of Dr. Juergen Vogt from the Herz und Diabetes Zentrum NRW in Bad Oeynhausen and Professor Dr. Burghard Schumacher from Rhon-Klinikum AG in Bad Neustadt. Professor Dr. Carina Blomstrom-Lundqvist from University Hospital in Uppsala, Sweden chaired the symposium.
Over 100 Arctic Front procedures have been completed at each clinic. In total, the data represents over 340 patients treated by Drs. Pitschner, Vogt and Schumacher. The data includes the original 19 proof of concept patients treated with the 21mm non-steerable balloon/sheath as well as the early feasibility data. It also includes patients with all types of AFib treated including paroxysmal, persistent and chronic.
In the cohort of true paroxysmal AFib patients, 84% were free of AFib after only one procedure. These are the same type of patients that are currently being enrolled and treated in the Company's pivotal STOP AF IDE trial in the United States. When additional patients with hypertension and persistent AFib were analyzed, 63% were free of AFib after one procedure. For patients with recurrence, chronic success rates rose to nearly 80% after a second procedure was performed.
"The results from these three centers are extremely encouraging. I am very excited about them," said Dr. Vogt. "They show a strong safety profile with clinical outcomes as good as, or better than, RF."
Additionally, Professor Dr. Luc Jordaens of Thoraxcentre Erasmus MC in Rotterdam, The Netherlands, presented his own series of over 100 patients with similar results. After a 20-30 patient learning curve, he demonstrated a decreased procedure time to under two hours in the first 50 patients treated.
Professor Dr. Karl-Heinz Kuck of the Asklepios Klinik St. Georg in Hamburg, Germany presented his own series of 26 patients with similar results. He also discussed his strategy to use a single, large 28mm Arctic Front balloon to isolate 98% of the pulmonary veins without CT or MRI pre-screening or patient pre-selection. He commented that the robust balloon is easy to use and does not require the use of a complex mapping system.
In the data presented at this symposia, no Arctic Front catheter related serious adverse events such as atrial esophageal fistula or PV stenosis were reported. All of Dr. Pitschner's multicentre data indicated up to a 7.5% rate of phrenic nerve injuries, however, all of them were resolved in a period between one to 365 days without clinical sequelae.
"These results, which demonstrate an 84% success rate in true paroxysmal AFib patients with structurally normal hearts, are truly exciting," said Jean-Pierre Desmarais, Chief Scientific Officer of CryoCath. "Not only do they reinforce our thesis that Arctic Front has the potential to become the gold standard of treatment for this disease, they also bode well for our STOP AF IDE results, as similar patients are being studied."
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 AFib. Approved in Europe, it has treated more than 750 patients in more than 24 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 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: For further information visit our website at www.cryocath.com, orcontact: Michael Moore, Investor Relations, Phone: (416) 815-0700 ext. 241,Fax: (416) 815-0080, E-mail: mmoore@equicomgroup.com