nContact Surgical initiates clinical trials of its convergent procedure for paroxysmal AF

Dec 2 2009

nContact Surgical, Inc. ("nContact"), a leader in the investigation of devices for minimally-invasive treatment for heart conditions, today announced the initiation of a feasibility clinical trial designed to evaluate the safety and efficacy of a combined surgical and catheter procedure, the convergent procedure, for the treatment of symptomatic paroxysmal atrial fibrillation (AF). This prospective, feasibility study will enroll patients at study sites across the United States.

"We designed this study to include paroxysmal patients with enlarged hearts, who historically have been more difficult to treat with catheter ablation in a single procedure," said John P. Funkhouser, President and CEO of nContact. "The uniqueness of the convergent procedure is that lesions can be created on all areas of the heart through a closed chest endoscopic approach, without lung deflation, and while the heart is beating. It is hoped that the combination of surgical and electrophysiology techniques will enhance physicians' capability to ultimately treat all AF patients in a single procedure."

The study utilizes the nContact Numeris®( )- AF Guided Coagulation System with VisiTrax® along with a commercially available ablation catheter, the Biosense Webster NaviStar®( )ThermoCool® Catheter. The combination of devices creates a standard, bi-atrial lesion pattern to block electrical signals that cause AF. In addition, electrophysiologists have the capability to diagnostically ensure the lesion pattern is complete with pulmonary vein isolation. "We look forward to investigating this collaborative, interdisciplinary approach for the treatment of atrial fibrillation in patients with larger atria," said Dr. Rodney Horton, Principal Investigator at St. David's Medical Center in Austin, Texas.