CryoCath Technologies Inc announced that its Freezor Xtra Surgical Cardiac CryoAblation Device has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), allowing the Company to launch its third product into the U.S. Freezor Xtra will allow physicians to surgically treat cardiac arrhythmias in the pericardial space by minimally invasive surgical techniques or directly during surgical cardiac procedures.
In a procedure using the subxyphoid approach pioneered by Dr. Eduardo Sosa from Incor Hospital (University of Sao Paulo, Brazil), Freezor Xtra will be used to make lesions on the outside surface of heart (the epicardial surface). The Freezor Xtra catheter will be fed through a mini keyhole just below a patient's sternum and be advanced through a hole made in the pericardial sac in order to reach the target epicardial location. It will then be used to create a focal lesion on the epicardium by delivering temperatures as low as -80 degrees C at its tip. This procedure is part of CryoCath's extensive cardiac cryoablation intellectual property portfolio.
Freezor Xtra will initially be released to a focused number of U.S. physicians who are experienced in Dr. Sosa's technique. CryoCath will convene a clinical advisory board meeting before year-end to discuss the physicians results and the most effective path to introduce this unique approach to a broader base of Electrophysiologists.