MORRISVILLE, N.C., April 19 /PRNewswire/ -- nContact Surgical, Inc (“nContact”) today announced it has received the first Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to evaluate the safety and efficacy of a combined surgical and catheter procedure (the convergent procedure) to treat patients with longstanding persistent atrial fibrillation (AF). nContact’s Numeris(R)-AF Guided Coagulation System with VisiTrax(R) will be used in combination with St. Jude Medical’s Therapy(TM) Cool Path(TM) Ablation Catheter.
During the convergent procedure, a cardiac surgeon and an EP work as a team to perform a closed chest epicardial ablation and endocardial catheter-based ablation procedure to treat a patient’s AF. The procedure does not require chest incisions or ports and incorporates mapping and diagnostic endpoints, as measured by the EP, to determine procedure completion.
John P. Funkhouser, President and CEO of nContact, said, “Cardiologists, EPs, and cardiac surgeons understand the difficulties in treating longstanding persistent AF patients and the associated limited outcomes. It is our hope that a convergence of surgical and electrophysiology techniques in a single procedure may provide an effective, minimally invasive, closed chest treatment option for longstanding persistent AF patients. St. Jude Medical has long been recognized as one of the premier manufacturers of medical devices that treat cardiac arrhythmias, and we are pleased to work with them in this study. nContact continues to pioneer the closed chest treatment for even the most difficult AF patient populations.”
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.
nContact Surgical, Inc.
