Healthcare Industry News:  endoscope 

Devices Cardiology

 News Release - May 13, 2010

nContact Advances Leadership Position in the Development of Closed Chest Ablation Techniques

Enrolls First Patient in IDE Trial of Closed Chest Convergent AF Ablation Procedure

Completes Preclinical Study to Expand Closed Chest Epicardial Ablation to Subxyphoid Approach

RALEIGH, N.C., May 13 -- (Healthcare Sales & Marketing Network) -- nContact Surgical, Inc. (nContact) announced it has enrolled the first patient in its IDE trials to evaluate a fully closed chest procedure combining the best of Electrophysiologist (EP) catheter and surgical techniques for the treatment of atrial fibrillation (AF) using the investigational Numeris® - AF Guided Coagulation System with VisiTrax®. The three hour procedure is performed in a single setting, generally in the EP Lab, by both physicians.

"nContact has pioneered a truly minimally invasive approach to epicardial ablation for the treatment of arrhythmias. Our enabling technology and novel access to the posterior of the heart have eliminated the need for chest incisions and ports, while providing direct visualization to create epicardial lesions," said Jim Whayne, Vice President of Clinicals. "We hope both of our closed chest IDE clinical trials will demonstrate that combining surgical and EP cardiology disciplines into one comprehensive procedure will improve efficacy and provide treatment for all atrial fibrillation patients, even the most difficult to treat longstanding persistent."

The Company also announced successful completion of a preclinical animal research study to evaluate its fully closed chest procedure for a subxyphoid (below the lower most part of the sternum) approach. Epicardial linear lesions were created percutaneously using this subxyphoid approach, as the device was advanced over a guide wire and manipulated throughout the heart.

"While it is too early to draw any conclusions, the new technique used in the research study allowed me to know where I was on the heart and to create atrial and ventricular lesions accurately without endoscopes," commented Dr. Miguel Valderrabano, Director of the Division of Electrophysiology at Houston's Methodist Hospital, DeBakey Heart and Vascular Center. "The development of this novel closed chest epicardial approach is critical to expanding patient access to treatment of arrhythmias."

About nContact Surgical, Inc.

nContact is a medical device company founded in 2005 with the company mission to develop devices for the endoscopic treatment of arrhythmias, including atrial fibrillation (AF). The Numeris® Coagulation System with VisiTrax® is based on the unique integration of suction, perfusion, and RF energy to ensure the creation of visible, non-conductive, bi-atrial epicardial lesions on a beating heart.

To date, The Numeris Coagulation System with VisiTrax is indicated for the coagulation of cardiac tissue in the United States. nContact has initiated clinical studies for the treatment of AF in both open and closed chest procedures. The Numeris Coagulation System with VisiTrax has CE Mark approval in Europe for the specific indication for the coagulation of cardiac tissue for the treatment of atrial fibrillation and atrial flutter.

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Source: nContact Surgical

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