Jan. 11, 2007 — First patients have been now been treated with the recently approved SurgiFrost XL, a new minimally invasive surgical probe for treating cardiac arrhythmias. CryoCath Technologies Inc. received FDA 510(k) clearance late in 2006, and the device also received CE mark approval during this same time period.
The first two patients were treated in December Dr. Gary Dworkin from Morton Plant Hospital, Clearwater, FL, and Dr. Saqib Masroor. Dr. Masroor treated a patient with intermittent atrial fibrillation and aortic valve disease. Dr. Dworkin treated a patient with eight years of permanent, symptomatic lone atrial fibrillation. Both patients underwent a standard sternotomy and a complete Cox Maze III lesion set utilizing an epicardially applied SurgiFrost XL without cardiopulmonary bypass support. Both patients left the operating room in sinus rhythm and are doing well.
SurgiFrost XL is a product line extension of CryoCath's SurgiFrost cryosurgical system, which has been the subject of several peer-reviewed publications, including a recently updated independent study pertaining to the ablation of Atrial Fibrillation (AF) using SurgiFrost.
For more information visit www.cryocath.com.