First Time Convergent Procedure Study Reports One-Year Data for Persistent Atrial Fibrillation

Wednesday, June 23, 2010 General News
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RALEIGH, N.C., June 23 nContact Surgical, Inc. (nContact) reports with interest today the results of a physician-initiated study of the Convergent Procedure that, for the first time, measured the progress of persistent atrial fibrillation (AF) patients at one-year and six-month intervals. Results of the study, which were presented at the 2010 International Society of Minimally Invasive Cardiac Surgeons (ISMICS) meeting in Berlin, Germany, indicated that after one year 80% of patients were in sinus rhythm and off anti-arrhythmic medication as a result of the closed chest, multi-disciplinary AF procedure.

The physician utilized the nContact coagulation device for the epicardial ablation portion of the Convergent Procedure. The technology is currently cleared for endoscopic cardiac coagulation in the US and is being further studied through IDE clinical trials for the treatment of AF in closed chest procedures.

In the podium session titled, "Simultaneous Catheter Ablations Enable a Comprehensive Epicardial Procedure for Persistent Atrial Fibrillation," Dr. Andy Kiser of FirstHealth Arrhythmia Center (FirstHealth) in Pinehurst, NC, reported the latest data on 65 AF patients who received the Convergent Procedure at FirstHealth or at The University Medical Center in Ljubljana, Slovenia. In this cohort, ninety-two percent of patients suffered from either persistent or longstanding persistent AF, which is historically a very difficult to treat patient population.

Of the 65 patients monitored, results were reported at one year post procedure for 25 patients and at six months post procedure for 40 patients. At one year, 88% were in sinus rhythm and 80% were in sinus rhythm and off anti-arrhythmic medications. At six months, 91% were in sinus rhythm and 72% in sinus rhythm and off anti-arrhythmic medications.

"This is the first time that results for the Convergent Procedure have been reported at one year and the results are impressive," said Professor Borut Gersak, co-investigator. "It must also be noted that 19 of the 20 patients at one year determined to be in sinus rhythm and free of anti-arrhythmic drugs were monitored continuously through an implantable device, Medtronic's Reveal monitor."

The podium session also examined Dr. Kiser's personal evolution from performing concomitant (open chest) surgical procedures, to minimally invasive, port-access surgical procedures, to the Convergent Procedure, where a cardiac surgeon and an electrophysiologist (EP) work as a team to perform a closed chest, epicardial-endocardial ablation procedure to treat a patient's AF.

Dr. Kiser's presentation concluded that the critical points for moving to the Convergent Procedure were (1) its ability to create a comprehensive bi-atrial lesion pattern on a beating heart, (2) the procedure is truly minimally invasive with small incisions outside the thorax, and (3) the co-disciplinary (surgeon and EP) collaboration is essential for success.

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 IDE 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.

Media Contacts Edgar Rey Kimberly Muscara/Jason Rando nContact Surgical The Ruth Group T (404) 285-0466 T (646) 536-7011/7025

SOURCE nContact Surgical, Inc.

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