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CryoCath receives approval to sell Freezor catheter system in Canada
Montreal | Friday, January 25, 2002, 08:00 Hrs  [IST]

CryoCath Technologies Inc (CYT), the world leader in cryotherapy products to treat cardiovascular disease, has received approval from the Therapeutic Product Directorate (TPD) of Canada's Health Protection Branch (HPB) to sell its Freezor CryoAblation System. The approval will allow Canadian medical practitioners and institutions to treat cardiac arrhythmias, including Atrial Fibrillation (AF), Supraventricular Tachycardia (SVT) and Atrial Flutter (AFl) with the revolutionary Freezor CryoAblation System.

"Canadian approval for Freezor is of key strategic importance for CryoCath, as it will facilitate approvals in several Asian and South American countries as well as Australia," said Steven G. Arless, President and CEO of CryoCath. "For this reason, the Canadian approval will be another important milestone towards the commercialisation of our technology globally and will build on the success we are currently enjoying in Europe."

CryoCath anticipates revenues from Canadian centers to begin soon after launch as a result of the research and development that the Company is conducting at three of the most advanced centres in Canada - the Montreal Heart Institute, University Hospital in London, Ontario and the Ottawa Heart Institute.

"Over the last five years of pioneering this technology, we have developed significant experience with cryoablation. We are excited that we may now use the device as part of our routine clinical practice in those applications where we believe the safety and effectiveness of cryoablation have a significant advantage over radiofrequency (RF) energy, such as in the treatment of Atrial Fibrillation and pediatric arrhythmias" said Dr. Marc Dubuc, Staff Cardiologist and Head of EPS Services, Montreal Heart Institute.

As the Company prepares for this initial foray into the North American market, it intends to leverage the experience gained in Canada and Europe into a successful U.S. launch anticipated for 2003. CryoCath expects to complete its pivotal U.S. IDE study before mid-2002, with enrolment now more than 70% complete.

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