MONTREAL, Nov. 28 /PRNewswire-FirstCall/ - CryoCath Technologies , 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 Front(R) (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 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.
CryoCath Technologies Inc.
CONTACT: visit our website at www.cryocath.com, or contact: Mike Polonsky,Investor Relations, Phone: (416) 815-0700 ext. 231, Fax: (416) 815-0080,E-mail: mpolonsky@equicomgroup.com
