CryoCath Arctic Front® Results Published in JACC
Strong efficacy results from a multi-center 293-patient European trial
Montreal, July 22, 2008 - 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.
About Medtronic CryoCath
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.
For further information, please contact:
