MONTREAL, April 24 /PRNewswire-FirstCall/ - CryoCath Technologies Inc. , the global leader in cryotherapy products to treat cardiovascular disease, today announced that additional data on the Company's proprietary Arctic Front catheter to treat Atrial Fibrillation (AF) was presented at the German Cardiac Society's 72nd Annual Conference in Mannheim, Germany on April 22, 2006.
Dr. H.F. Pitschner from the Kerckhoff Klinik in Bad Nauheim, Germany reported acute data following ablation procedures on 39 patients. 100% of the cases were considered successful, with complete isolation of all pulmonary veins, of which 90% were isolated using only Arctic Front.
Dr. Juergen Vogt from the Herz und Diabetes Zentrum NRW in Bad Oeynhausen, Germany reported acute data following ablation on 45 patients. He achieved 100% acute success with complete electrical isolation of all pulmonary veins, of which approximately 70% were isolated using only Arctic Front.
Dr. Vogt also reported results on 25 of these patients three to six months after their treatments. 80% of the 25 patients were AF-free; of these patients, 15 were AF-free after only one procedure and five following a second procedure that involved minimal vein touch up. 20% of the 25 patients who were not AF-free, have all experienced a clinically significant reduced AF burden and do not require any further treatment.
"After using Arctic Front now on more than 45 patients, I believe this tool has the potential to be an effective and very safe treatment for AF," said Dr. Vogt. "Certainly, the strong acute and positive early chronic data suggests that Arctic Front is an efficient tool to isolate the pulmonary veins."
No stenosis, thrombosis, esophageal perforation or stroke were reported at either centre. In approximately 5% of cases, phrenic nerve palsy, predominantly asymptomatic, was reported. The rate of incidence observed is consistent with that recorded in both the U.S. and European feasibility studies. All incidences of phrenic nerve palsy from these studies were ultimately resolved.
"This initial commercial data demonstrates that Arctic Front is a practical tool for the treatment of AF in a typical cath-lab setting," said Steve Arless, President and CEO of CryoCath. "Furthermore, it reinforces our belief that Arctic Front has the potential to dominate the treatment of this disease."
Data presented at the conference was obtained in a commercial setting, as part of the company's controlled beta launch in Europe initiated following CE Mark approval in July 2005. The launch is continuing to progress with 10 centres now participating. In all of the cases performed to date as part of the launch, no adverse events like stenosis, esophageal perforation or stroke have been recorded.
About Arctic Front
The Arctic Front catheter was designed to treat Atrial Fibrillation. This bi-directional balloon catheter enables physicians to isolate all four pulmonary veins and create large, durable transmural lesions that stop the incidence of AF episodes.
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 CryoCath(R)
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).
This press release includes "forward looking statements" that are subject to risks and uncertainties. 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 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,or contact: Steve G. Arless, President & CEO, Phone: (514) 694-1212 ext.224, E-mail: sarless@cryocath.com; Mike Polonsky, Investor Relations,Phone: (416) 815-0700 ext. 231, Fax: (416) 815-0080, E-mail:mpolonsky@equicomgroup.com