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GLP Preclinical Studies Demonstrate nContact Ablation Lesions Are Complete and Transmural
Date:1/25/2013

MORRISVILLE, N.C., Jan. 25, 2013 /PRNewswire/ -- Innovations In Cardiac Rhythm Management published an article by Dr. H. Edward Garrett, Jr. , MD of Baptist Memorial Hospital, Memphis, TN that evaluated nContact's unipolar epicardial ablation devices, the Numeris® and EPi-Sense® Coagulation Systems with VisiTrax®. The study purpose was to measure the ability of the device to create transmural epicardial lesions. During two chronic GLP preclinical studies performed at two sites, Saint Joseph's Translational Research Institute in Atlanta, and Integra, a USDA registered facility in Minneapolis, Minnesota, the coagulation systems produced effective epicardial ablation lesions on a beating heart that were consistently transmural in the atria and measured 7mm in depth.

Though the Company has performed thousands of ablation procedures on humans with its coagulation system involving both surgeons and EPs utilizing diagnostic and mapping technologies to assure lesion transmurality and area isolation, the paper reaffirms the science behind the technology. "The Company has always maintained that the primary weakness of other RF technologies was not maintaining consistent tissue contact on a beating heart. By integrating suction into the nContact device, it allowed consistent tissue contact and energy transmission across the ablation device which has resulted in complete long linear lesions. The conclusion of the new studies confirmed what the initial Company studies had shown," stated Dr. H. Edward Garrett, Jr. , Professor of Cardiothoracic Surgery at the University of Tennessee, Memphis.

Dr. Garrett continued, "To the Company's credit, the studies were performed under the rigorous standards of GLP and utilization of histology. Histology studies demonstrated
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