CryoCath receives FDA approval to expand AF trial
Montreal, Quebec, Canada - November 28, 2006 - CryoCath Technologies (TSX:CYT), the global leader in cryotherapy products to
treat cardiovascular disease, today announced it has received notification from
the U.S. Food and Drug Administration (FDA), allowing the Company to expand its
pivotal Investigational Device (IDE) STOP AF trial. Effective immediately, the
Company can now enroll up to 150 patients in up to 20 centers.
To date, five centers have received Internal Review Board (IRB) approval and
have begun screening patients, including 16 that have already been enrolled and
randomized. The Company expects four additional centers to come online in
December with the remainder to be actively recruiting patients early in the new
calendar year.
“This new approval from the FDA allows us to start enrolling patients in up to
20 centers as we requested at the beginning of the trial,” said Jean-Pierre
Desmarais, Chief Scientific Officer. “This expansion in centers and patients
allows us to keep executing our enrolment strategy to plan and to maintain our
timelines for completing this trial on schedule.”
About STOP AF Trial
As many as 250 patients, randomized
into two arms, will be enrolled to complete the trial. One cohort will receive
cryoablation therapy with Arctic Frontä
(the ablation arm); the other will receive currently prescribed drug therapies
(the control arm). For every two patients in the ablation arm, there will be one
in the control arm. Patients in the trial will be highly symptomatic paroxysmal
Atrial Fibrillation (AF) patients who have failed at least one anti-arrhythmic
drug. The trial’s primary endpoint will be the absence of detectable AF at the
end of the 12-month follow up period. The trial’s design also allows patients
randomized into the drug arm to cross over into the ablation arm if they do not
show improvement.
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 300
patients in more than 18 centers.
About Atrial Fibrillation
AF, described as a rapid and
chaotic quivering of the top two chambers in the heart, is the most prevalent
arrhythmia, affecting more than 2 million patients in the U.S. with an annual
incidence of 160,000 new cases per year. It is a leading cause of stroke and
hospitalizations, and has become the most common complication of cardiovascular
surgery. If left untreated, it can lead to heart failure and death.
About Medtronic 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.
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