GLP Preclinical Studies Demonstrate nContact Ablation Lesions Are Complete and Transmural
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 that acute studies utilizing TTC staining may not provide an accurate and objective conclusion to the question of lesion depth. The studies demonstrated that unipolar RF energy, when in consistent tissue contact, can safely create complete lesions, and coagulate to a consistent depth. In a larger context, lesion consistency and transmurality are considered key elements to ablation success, and this study has gone a long way to explaining the superior results obtained over other ablation technologies at my institution.”
About nContact, Inc.
nContact, Inc. is the leading innovator in epicardial ablation devices and techniques. Its mission is to transform the underserved arrhythmia market through the advancement of less invasive, more efficacious ablation alternatives for cardiac arrhythmias.
Its lead technologies, the EPi-Sense® and Numeris® Coagulation Systems with VisiTrax®, have CE Mark approval in Europe for the coagulation of cardiac tissue for the treatment of atrial fibrillation and atrial flutter.
The EPi-Sense® and Numeris® Coagulation Systems with VisiTrax® are indicated for endoscopic coagulation of cardiac tissue in the United States. nContact was founded in 2005 and is headquartered in Morrisville, North Carolina, U.S.A.
PRLog ID: www.prlog.org/12065488