www.cryocath.com Toronto Stock Exchange Symbol: CYT
MONTREAL, June 28 /CNW/ - CryoCath Technologies Inc. (TSX: CYT), the
global leader in cryotherapy products to treat cardiovascular disease, today
announced that data on the Company's proprietary Arctic Front(R) catheter
system to treat Atrial Fibrillation (AFib) was presented at the European
Society of Cardiology (Europace) Conference in Lisbon, Portugal from June
24-27, 2007. Electrophysiologists from around the world attend this bi-annual
conference to discuss cardiac arrhythmias.
On June 25, in a satellite symposium entitled "State of the Art Treatment
of Atrial Fibrillation: The Arctic Front Cryoballoon Catheter," Dr.
Heinz-Friedrich Pitschner from the Kerckhoff-Klinik in Bad Nauheim, Germany
presented data from three centers on behalf of Dr. Juergen Vogt from the Herz
und Diabetes Zentrum NRW in Bad Oeynhausen and Professor Dr. Burghard
Schumacher from Rhon-Klinikum AG in Bad Neustadt. Professor Dr. Carina
Blomstrom-Lundqvist from University Hospital in Uppsala, Sweden chaired the
Over 100 Arctic Front procedures have been completed at each clinic. In
total, the data represents over 340 patients treated by Drs. Pitschner, Vogt
and Schumacher. The data includes the original 19 proof of concept patients
treated with the 21mm non-steerable balloon/sheath as well as the early
feasibility data. It also includes patients with all types of AFib treated
including paroxysmal, persistent and chronic.
In the cohort of true paroxysmal AFib patients, 84% were free of AFib
after only one procedure. These are the same type of patients that are
currently being enrolled and treated in the Company's pivotal STOP AF IDE
trial in the United States. When additional patients with hypertension and
persistent AFib were analyzed, 63% were free of AFib after one procedure. For
patients with recurrence, chronic success rates rose to nearly 80% after a
second procedure was performed.
"The results from these three centers are extremely encouraging. I am
very excited about them," said Dr. Vogt. "They show a strong safety profile
with clinical outcomes as good as, or better than, RF."
Additionally, Professor Dr. Luc Jordaens of Thoraxcentre Erasmus MC in
Rotterdam, The Netherlands, presented his own series of over 100 patients with
similar results. After a 20-30 patient learning curve, he demonstrated a
decreased procedure time to under two hours in the first 50 patients treated.
Professor Dr. Karl-Heinz Kuck of the Asklepios Klinik St. Georg in
Hamburg, Germany presented his own series of 26 patients with similar results.
He also discussed his strategy to use a single, large 28mm Arctic Front
balloon to isolate 98% of the pulmonary veins without CT or MRI pre-screening
or patient pre-selection. He commented that the robust balloon is easy to use
and does not require the use of a complex mapping system.
In the data presented at this symposia, no Arctic Front catheter related
serious adverse events such as atrial esophageal fistula or PV stenosis were
reported. All of Dr. Pitschner's multicentre data indicated up to a 7.5% rate
of phrenic nerve injuries, however, all of them were resolved in a period
between one to 365 days without clinical sequelae.
"These results, which demonstrate an 84% success rate in true paroxysmal
AFib patients with structurally normal hearts, are truly exciting," said
Jean-Pierre Desmarais, Chief Scientific Officer of CryoCath. "Not only do they
reinforce our thesis that Arctic Front has the potential to become the gold
standard of treatment for this disease, they also bode well for our STOP AF
IDE results, as similar patients are being studied."
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 AFib. Approved in Europe, it has treated more than 750
patients in more than 24 centers.
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
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, 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.
For further information:
For further information: visit our website at www.cryocath.com, or
contact: Michael Moore, Investor Relations, Phone: (416) 815-0700 ext. 241,
Fax: (416) 815-0080, E-mail: email@example.com