MONTREAL, Jan. 4 /PRNewswire-FirstCall/ - CryoCath Technologies Inc., the global leader in cryotherapy products to treat cardiovascular disease, today announced that the first patients have been treated with SurgiFrost XL, a new minimally invasive surgical probe for treating cardiac arrhythmias which the U.S. Food and Drug Administration provided 510(k) clearance for in late 2006. It also received CE mark approval during this same time period.
"My experience with SurgiFrost XL in a pre-clinical setting confirms its ability to create durable, transmural lesions in a beating heart," said Dr. Saqib Masroor from Hackensack University Medical Center in Hackensack, New Jersey. "Given these results, SurgiFrost XL presents physicians with a viable, minimally invasive option to treat cardiac arrhythmias in stand-alone procedures."
The first two patients were treated prior to the end of December 2006 by Dr. Gary Dworkin from Morton Plant Hospital, Clearwater, Florida and Dr. Saqib Masroor. Dr. Masroor treated a patient with intermittent atrial fibrillation and aortic valve disease. Dr. Dworkin treated a patient with eight years of permanent, symptomatic lone atrial fibrillation. Both patients underwent a standard sternotomy and a complete Cox Maze III lesion set utilizing an epicardially applied SurgiFrost XL without cardiopulmonary bypass support. Both patients left the operating room in sinus rhythm and are doing well.
"Up until now, treating cardiac arrhythmias without invasive surgery has proven to be a technical challenge for the surgical community; SurgiFrost XL addresses that challenge, said Allan Zingeler, CryoCath's Vice-President, Global Marketing. "It provides the proven benefits of cryotherapy and is a product designed to perform a less invasive procedure. As such, we anticipate this product will play a key role in unlocking the potential for surgeons to treat cardiac arrhythmias simply and completely in a minimally invasive procedure, one that may obviate the need for cardiopulmonary bypass support."
SurgiFrost XL is a product line extension of CryoCath's SurgiFrost cryosurgical system, which has been the subject of several peer-reviewed publications including a recently updated independent study pertaining to the ablation of Atrial Fibrillation (AF) using SurgiFrost. An article published in The Annals of Thoracic Surgeons (September 2005) by James Gammie of the University of Maryland demonstrated robust results. 95%, or 35 of 37 patients, were AF free at a mean follow-up of 12 months. A further update from Dr. Gammie presented at the 2006 Southern Thoracic Surgical Association meetings revealed now a total of 119 patients with similar efficacy. An additional highpoint of Dr. Gammie's results is an almost complete absence of pacemaker implants (3.4%) post procedure. There were no adverse device related events reported in the study.
At present, CryoCath's SurgiFrost systems are routinely used in more than 400 surgical centers around the world. CryoCath estimates that the annual global market opportunity for the Company's surgical devices to treat cardiac arrhythmias including AF could grow to be more than US$250 million.
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