Healthcare Industry News:  cryoablation 

Devices Cardiology FDA

 News Release - March 28, 2007

CryoCath receives FDA approval to expand STOP AF trial to full cohort of patients

MONTREAL, March 28 (HSMN NewsFeed) - 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 FrontŪ 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.

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.


Source: CryoCath Technologies

Issuer of this News Release is solely responsible for its content.
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