MONTREAL, May 27 /PRNewswire-FirstCall/ -- CryoCath Technologies Inc., the global leader in cryotherapy products to treat cardiovascular disease, today announced that it has completed enrollment in the first stage of its two-part Investigation Device Exemption (IDE) study for the treatment of Atrial Fibrillation (AF). The study involves a unique “tool box” approach to treat AF using up to three different CryoCath catheters: Arctic Circler(TM), Freezor(R) Xtra and Freezor(R) MAX.
The first stage of the study, designed to establish the safety and viability of the “tool box” approach, enrolled 24 patients and was conducted in Boston at the Massachusetts General Hospital under Dr. Vivek Reddy, in Tampa, Florida at St. Joseph’s Hospital by Dr. Jim Irwin, and in Colorado Springs, Colorado at Memorial Hospital by Dr. Chris Cole. Dr. Reddy is acting as the principal investigator for the trial.
Initial results showed a 95% acute success rate in achieving electrical isolation in all treated veins. As per the trial protocol, there was also a 95% success rate in establishing a flutter ablation line (confirmed by bi-directional block) in the right atrial isthmus to proactively prevent Atrial Flutter, which often triggers AF events. There were no reports of serious adverse events.
“The early results from this trial, demonstrating the safety and feasibility of this approach, suggests a potentially exciting advancement in the field of AF ablation,” said Dr. Chris Cole. “We eagerly anticipate the initiation of the next stage of this trial.”
“These results, in conjunction with our recently announced Arctic Circler Balloon data, indicate the strength of the “tool box” strategy and its utility in the safe and effective treatment of AF,” said Steven G. Arless, President and CEO of CryoCath. “Our catheter-based solutions, in conjunction with our commercialized surgical system, which continues to gain market share, position us as a leader in the fight against this widespread cardiac disease.”
Subsequent to receipt of final three-month chronic safety (stenosis) results and six-month safety and efficacy data, expected in September and December respectively, the Company intends to initiate the second stage of the study. The pivotal study, scheduled to begin in the first quarter of calendar 2005, will generate sufficient data to support submission of a Pre-Marketing Approval (PMA) application to the US Food and Drug Administration (FDA). The final protocol for the second stage of the study is currently in development, but based on the encouraging preliminary data derived from the Arctic Circler Balloon human feasibility study, the Company intends to incorporate this proprietary catheter in the final stage of the “tool box” clinical trial.
This announcement comes on the heels of the Company’s attendance at the Heart Rhythm 2004 Conference (formerly NASPE) held this year in San Francisco. At this year’s 4-day event, strong interest in cryoablation was highlighted by the 10 abstracts and 2 presentations given specifically on the topic. As well, the Company’s annual symposium saw a record attendance. Heart Rhythm is the largest industry conference of its kind and represents a key marketing and lead generation event for CryoCath.
“Tool Box” Approach
Arctic Circler Linear and Arctic Circler Balloon, both uniquely configured to treat AF originating in the PV, have the ability to create lesions rapidly within the ostia (openings) of the four PVs. Freezor Xtra can be used to touch up gaps, resulting from unique PV anatomy, if necessary. Freezor MAX will be used to create a flutter ablation line in all AF patients whether Atrial Flutter is present or not.
About AF
AF is a disorder of the heart characterized by rapid and chaotic beating of the atria and is the most prevalent cardiac arrhythmia, affecting four million patients in the western world. AF is one of the leading causes of stroke and short-term hospitalizations with 400,000 new cases annually. Despite its prevalence, there are no current, practical clinical options to effectively and safely treat AF. Catheter ablation to resolve AF’s underlying cause, aberrant electrical signals originating on the left side of the heart near or within the pulmonary veins, has been restricted by safety concerns. As a result, the standard treatments for AF are limited to various costly drug regimens that offer only a palliative (non-curative) approach.
About CryoCath(R)
CryoCath - http://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. and across Europe. 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 http://www.cryocath.com/, or contact Steven G.Arless, President & CEO, CryoCath Technologies Inc., Tel: (514) 694-1212 ext.224, sarless@cryocath.com; Mike Polonsky, Investor Relations, Tel:(416) 815-0700 ext. 231, Fax: (416) 815-0080, mpolonsky@equicomgroup.com