- Strong efficacy results from a multi-center 293-patient European
Toronto Stock Exchange Symbol: CYT
MONTREAL, July 22 /CNW/ - CryoCath(R) 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(R), 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
Gefdss-Klinik in Bad Neustadt and Dr. Pitschner from the Kerckhoff-Klinik in
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(R) 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
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.
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
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:
For further information: visit our website at www.cryocath.com, or
contact Ross Marshall, Investor Relations, Phone: (416) 815-0700 ext. 238,
Fax: (416) 815-0080, E-mail: firstname.lastname@example.org