Toronto Stock Exchange Symbol: CYT
MONTREAL, March 28 /CNW/ - 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 for Arctic Front(R) to the full
cohort of patients in all 20 centers. The trial is designed to demonstrate
Arctic Front's clinical and therapeutic effectiveness in treating paroxysmal
Atrial Fibrillation (AF) when compared to traditional medical therapy.
"FDA approval for final and complete expansion of our STOP AF trial
enables us to continue executing our enrolment strategy with a definitive
outlook on centers and patients," said Jean-Pierre Desmarais, Chief Scientific
Officer. "We can now drive Arctic Front forward with the main focus being the
execution of the trial in front of us."
CryoCath recently discovered a small one time packaging issue with
FlexCath(TM) steerable sheath units, an access system used in conjunction with
Arctic Front to aid in deploying it to targeted pulmonary veins. The Company
has initiated a voluntary product removal from the clinical centers, since
corrected the issue and is working closely with FDA to ensure the corrective
measures are reviewed and approved. It is believed that this review will have
minimal impact on the study. To date, we have been very satisfied with our
ability to start up centers and their corresponding ability to enroll patients
in this landmark trial. Based on this experience, the Company believes we can
complete enrolment by the end of 2007.
About the STOP AF Trial
The goal of the Cryo System Trial Of Paroxysmal Atrial Fibrillation (STOP
AF) is to demonstrate Arctic Front's safety and effectiveness for the
treatment of Paroxysmal Atrial Fibrillation (PAF) when compared to traditional
anti-arrhythmic drug therapy. As many as 270 patients, randomized into two
arms, will be enrolled to complete the trial. One cohort will receive
cryoablation therapy with Arctic Front (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. Once the follow up period is completed, CryoCath will file a
Pre-Market Approval (PMA) application to the FDA with the intent to obtain
approval for the Arctic Front system for the treatment of PAF.
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 500 patients
in more than 24 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 2.3 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.
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.
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: firstname.lastname@example.org