MONTREAL, June 19 /PRNewswire-FirstCall/ - CryoCath Technologies Inc. , the global leader in cryotherapy products to treat cardiovascular disease, today announced that independent peer reviewed data on the Company’s proprietary Arctic Front(TM) catheter to treat paroxysmal Atrial Fibrillation (AF) was presented at Cardiostim, the 15th Annual World Congress in Cardiac Electrophysiology and Cardiac Techniques in Nice, France.
Dr. Jordaens, based in Rotterdam, Netherlands reported 100% acute success, as measured by the compete electrical isolation of the pulmonary veins, following ablation on 26 patients treated for paroxysmal AF using Arctic Front. 80% of the pulmonary veins were isolated using Arctic Front only. Dr. Jordaens also reported that 87% of the 15 patients who have now reached the three month follow up point were AF free and off all anti-arrhythmic drugs. No stenosis, thrombosis, esophageal perforation or stroke were reported. Three cases of phrenic nerve palsy were reported, all of which resolved.
“On their own merit, these results are very encouraging and again reinforce our conviction that Arctic Front’s therapeutic potential to be a comprehensive solution for AF is unmatched in the field of cardiac ablation,” said Jean-Pierre Desmarais, CryoCath’s Chief Scientific Officer. “Moreover, we are now beginning to see a critically important trend that suggests the clinical benefits from using Arctic Front can be reproduced center after center. Dr. Jordaens results represent the fourth data set on a significant number of patients and are highly consistent with the previously announced outcomes from two German clinics and the initial IDE data from the U.S.”
Arctic Front is approved for use in Europe and the patients reported on were treated as part of the routine practice of Dr. Jordaens’ clinic. In the U.S., Arctic Front is currently being evaluated in an IDE feasibility study. CryoCath recently announced it was expanding this trial by 15 additional patients and enrolment of these patients is proceeding as planned.
Also during the conference in a separate presentation, Dr. Drago from Rome, Italy presented data on the Company’s 4mm focal catheter Freezor(R) to treat pediatric patients with Supraventricular Tachycardias (SVT). Using six minute ablations, he treated 36 patients and achieved 100% acute success and 92% chronic success. These results are higher than those generally reported in the literature for RF ablation on pediatric patients. Again, there were no serious adverse events.
Added Mr. Desmarais, “Dr. Drago’s results again underscore that the safety advantages of cryoablation allow physicians to more aggressively and successfully treat a wide variety of higher risk arrhythmias, such as AF or those found in the smaller hearts of children.”
About Arctic Front
The Arctic Front catheter was designed to treat paroxysmal Atrial Fibrillation. This bi-directional, double balloon catheter enables physicians to isolate all four pulmonary veins and create large, durable transmural lesions that stop the incidence of AF episodes.
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: 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@equicompgroup.com