CryoCath Reports Positive 12-month Data for Arctic Front™
84% of Patients Free from Symptomatic Atrial Fibrillation
Montreal, Quebec, Canada - September 6, 2005 - CryoCath Technologies Inc. (TSX:CYT), the global leader in cryotherapy products to treat cardiovascular disease, today announced that Dr. H.F. Pitschner of the Kerckhoff Klinik in Bad Nauheim, Germany presented additional data on the Arctic Front catheter to treat Atrial Fibrillation (AF). The data was presented at the European Society of Cardiology Congress 2005 in Stockholm, Sweden on September 4, 2005.
84%, or 16 of 19 patients treated, are AF-free at the 12-month follow-up point. Another patient was retreated and is now AF free at six months with a 12-month follow-up in October 2005. No serious adverse device-related events such as stenosis, stroke or esophageal perforation were reported. Of the three patients who were clinically deemed “treatment failures,” two are now off drugs, have had a significant reduction in burden and have conditions that do not warrant re-treatment and are considered clinically successful.
“With an 84% success rate, these results truly speak for themselves. Arctic Front has a strong safety profile and appears to provide a practical ablation option for treating AF. This device may prove to be exactly what electrophysiologists have been waiting for as a viable AF catheter,” said Dr. Pitschner. “I have begun to use the Arctic Front in my own practice and will continue to do so. I believe this product will emerge as an indispensable tool.”
The 20-patient study was conducted at two European centres: Homalka Hospital in Prague, under the direction of Dr. Vivek Reddy of the Massachusetts General Hospital and Dr. Petr Neuzil of the Czech Republic; and at the Kerckhoff Klinik, Germany, under the direction of Dr. H.F. Pitschner.
“With 84% of patients free from AF at the 12-month follow up point, these results are highly encouraging and suggest that patients can be effectively treated with Arctic Front.” said Jean-Pierre Desmarais, Chief Scientific Officer of CryoCath. “The initial beta launch in Europe is continuing to progress smoothly and on schedule. Four of our target 8 centres are now participating with more than 20 cases performed to date.”
About Arctic Front
The Arctic Front catheter has been designed to overcome the three principal obstacles in providing a commercially viable ablation solution for treating AF – safety limitations, inadequate chronic success rates and lengthy/complex procedures. With regards to safety, all the clinical results from the prior use of cryoenergy in and around the pulmonary veins suggests that this energy source does not generate serious adverse events such as stenosis (narrowing of the vein), thrombosis (clot formation), and esophageal perforation - three complications that have been consistently reported with alternative heat-based ablation systems. With respect to efficacy, data from a 20 patient European study using Arctic Front suggests success rates well above traditional point-to-point RF ablation techniques. With respect to simplifying the ablation of the pulmonary veins and reducing procedural times, the innovative balloon design allows the entire surface area of the encircling atrial tissue of the pulmonary veins to be ablated at one time, thereby reducing the number of lesions required. As well, the natural contours of the catheter’s balloon shape allow for simple and effective anatomical placement of the catheter balloon in the target region of the encircling atrial tissue of the pulmonary veins. As a result, procedures are expected to be completed in less than 2.5 hours (skin-to-skin).
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 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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