nContact Announces First IDE Study to Research Closed Chest Convergent Ablation Procedure for Longstanding Persistent Atrial Fibrillation

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®-AF Guided Coagulation System with VisiTrax® will be used in combination with St. Jude Medical's Therapy™ Cool Path™ Ablation Catheter.

AF is the most common cardiac arrhythmia (abnormal heartbeat), affecting an estimated 3.3 million Americans and millions more worldwide. Longstanding persistent AF has historically been the most challenging cardiac arrhythmia to treat individually by either the electrophysiologist (EP) or cardiac surgeon. The condition is typically associated with other serious health issues such as structural heart disease and heart failure. The majority of these patients have limited treatment options.

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.

The IDE study is designed to evaluate the safety and efficacy of the convergent procedure, utilizing the skills of both the EP and cardiac surgeon. The primary effectiveness endpoint from the multicenter, prospective trial is freedom from AF and freedom of all Class I and III Anti Arrhythmic Drugs (AADs).

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."

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.

For more information, please visit www.ncontactsurgical.com.

SOURCE nContact Surgical, Inc.

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