Healthcare Industry News: CryoBalloon
News Release - July 22, 2008
CryoCath Arctic Front(R) Results Published in JACCStrong efficacy results from a multi-center 293-patient European trial
MONTREAL, July 22 (HSMN NewsFeed) - CryoCath® Technologies Inc., the global leader in cryotherapy products to treat cardiac arrhythmias, today announced that results previously presented from three European study centers using the Company's lead product, Arctic Front®, were published earlier today in the Journal of the American College of Cardiology (JACC).
The peer-reviewed article entitled, 'Circumferential Pulmonary Vein Isolation with the CryoBalloon Technique', appears in the July 22nd edition of JACC and is available online at http://content.onlinejacc.org. It discusses the three-center trial in which 74 percent of the 293 paroxysmal AFib patients enrolled were AFib free and off anti-arrhythmic drugs (AADs) after only one procedure with Arctic Front upon a median follow-up time of 12 months.
"As we continue to increase our market share in Europe, this article adds to the growing body of evidence that is creating a very clear picture of Arctic Front's clinical potential as a simple, safe and effective treatment for paroxysmal AFib," said Jan Keltjens, President and CEO of CryoCath. "Ensuring physicians have access to tangible scientific evidence on the benefits of Arctic Front is part of our strategy to drive product adoption and build upon the strong base of business we have already established."
The study, conducted in Germany, was led by Dr. Vogt from the Herz und Diabetes Zentrum NRW in Bad Oeynhausen, Prof. Dr. Schumacher from Herz- und Gefäss-Klinik in Bad Neustadt and Dr. Pitschner from the Kerckhoff-Klinik in Bad Nauheim.
The patients enrolled in the 346-person study were predominantly paroxysmal AFib sufferers (n=293) with a small group of persistent AFib patients (n=53). Of the 1,403 pulmonary veins treated, 1,360 (or 97 percent) were ablated with Arctic Front or Arctic Front in combination with CryoCath's Freezor® MAX catheter demonstrating the broad applicability of Arctic Front cryoablation. The median number of applications per vein was 2.8 and the median total procedure time was 170 minutes confirming the ease of use and speed with which physicians are able to use Arctic Front compared with other ablation technologies.
The safety data reported in the article confirms the strong safety profile Arctic Front has demonstrated to date. There were no observed reports of atrio esophageal fistula, stroke, death or peri-interventional complications. Phrenic nerve palsies were reported in 7.5 percent of patients treated; in some instances these were resolved prior to the end of the procedure or hospital discharge and all cases were resolved by the 12-month follow up visit.
"This study demonstrates the utility of Arctic Front in effectively isolating the pulmonary veins, which is the clear strategy for treating paroxysmal AFib, and central strategy in treating persistent AFib," added Mr. Keltjens.
About Arctic Front
Arctic Front is a minimally invasive cryo-balloon catheter designed specifically to treat paroxysmal Atrial Fibrillation. This bi-directional, double balloon catheter enables physicians to rapidly isolate all four pulmonary veins for the treatment of AFib. More than 2,600 patients have been treated in more than 45 centres across Europe.
CryoCath - www.cryocath.com - is a medical technology company that leads the world in cryotherapy products to treat cardiac arrhythmias. With a priority focus on providing physicians with a complete solution of catheter 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, 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
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