CryoCath Technologies Inc has submitted to the U.S. Food and Drug Administration (FDA) the fifth and final module in the Company's Pre-market Approval (PMA) filing plan for the Freezor Cardiac Cryoablation System. This module presents clinical results of the Company's 165 patient pivotal FROSTY trial, which was designed to determine Freezor's safety and effectiveness in treating Supraventricular Tachycardia (SVT).
The Company is confident with the results of the FROSTY trial and it now looks forward to working closely with the FDA in obtaining approval for market release in an efficient and expedient manner. The results of the FROSTY trial are expected to be released upon completion of the FDA review process.
"Today's announcement keeps us on plan to launch Freezor into the U.S. marketplace within 12 months," said Steven G. Arless, President & CEO of CryoCath Technologies. "In Europe and elsewhere, Freezor is already on its way to becoming a preferred option to treat up to 50 per cent of all SVT arrhythmias."
Freezor is a flexible, single use, minimally invasive cryoablation catheter specifically designed to create focal lesions to treat high-risk arrhythmias near the AV node where precision is of critical importance. Freezor can reach temperatures at its tip as low as -80ºc inside a beating heart.
"The consensus opinion from the clinical investigators in the FROSTY trial suggests that a cryoablation catheter would be a unique and clinically valuable addition to an electrophysiologist's toolbox," said co-principal investigators Drs. Marc Dubuc of the Montreal Heart Institute and Peter Friedman of Brigham & Women's Hospital. "In particular, we believe the safety profile afforded by the use of cryo-energy to ablate provides the physician with a greater level of confidence in treating higher-risk perinodal arrhythmias such as seen in Atrioventricular Nodal Reentry Tachycardia (AVRNT), an arrhythmia class typically comprising 60-70 per cent of all SVT cases."