Healthcare Industry News:  Balloon catheter 

Devices Cardiology

 News Release - March 8, 2007

CryoCath Reports Positive 6-Month Follow up Data from U.S. AFIB Trial

100% Free from Detectable AFIB

MONTREAL, March 8 (HSMN NewsFeed) - CryoCath (TSX: CYT ), the global leader in cryotherapy products to treat cardiovascular disease, today announced six month follow up data from 18 patients treated during the feasibility stage of its STOP AF IDE trial. The trial, which is now in the pivotal stage, is assessing the Company's proprietary Arctic FrontĀ® catheter to treat Atrial Fibrillation (AFIB), the most prevalent cardiac arrhythmia affecting more than 4.3 million people worldwide.

Of the total 33 patients treated during the feasibility stage, the second cohort of 18 patients, which have been treated with 23 mm or 28 mm catheters as in the pivotal trial, has now reached the 6-month mark. All patients from the second cohort were free of detectable AFIB at six months. Three of the patients required a second procedure which is permissible under the protocol set for the trial. Of these three patients, one is still receiving anti-arrhymthmic drug (AAD) treatment. All of the remaining 17 patients are off AAD's. No serious adverse events were reported other than two phrenic nerve palsies. These two patients were asymptomatic at the time of hospital release post procedure. In comparison to the original fifteen patients in the first cohort of which 73% were AFIB free at the 6-month mark, these new results show a noteworthy improvement.

"The data that continues to emerge from this trial is very encouraging. These results show an improvement over the first cohort of 15 patients and underscore the consistency of Arctic Front as a treatment alternative for AFIB," said Jean-Pierre Desmarais, Chief Scientific Officer, CryoCath. "In comparison to the 40 per cent success rate reported in medical literature using current AAD therapies, these results are outstanding. They underpin our conviction that Arctic Front has strong potential to become the new gold standard of therapy to treat AFIB and consolidate the momentum we have gained in the pivotal study."

As well, CryoCath announced it has received CE Mark approval for its Generation V Universal Console. In addition to several technical improvements, this next generation console is the first that can operate both CryoCath's focal FreezorĀ® line of catheters as well as Arctic Front.

"Seeing this data emerge is very exciting. Clinical outcomes like these continue to build our confidence for the STOP AF trial and will further drive adoption in Europe and other regions," said Jan Keltjens, President and CEO of CryoCath. "And, with the continual improvements to our products, like the new Universal Console, we demonstrate our dedication to becoming the dominant provider of AFIB solutions."

About Arctic Front

Arctic Front is a minimally invasive cryo-Balloon catheter designed specifically to treat Atrial Fibrillation. This bi-directional, double Balloon catheter enables physicians to rapidly isolate all four pulmonary veins for the treatment of AF. Approved in Europe, it has treated more than 500 patients in more than 24 centers.

About 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.

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.


Source: CryoCath Technologies

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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