nContact, Inc. Announces CE Mark Approval of its Generation 4 "EPi-Sense(TM)" Epicardial Ablation System

MORRISVILLE, North Carolina, August 18, 2011 -

– First Multi-disciplinary, All-in-One Tool that Enables Epicardial Ablation, Mapping and Navigation for the Treatment of Cardiac Arrhythmias –

nContact, Inc. (nContact), the leading innovator in epicardial ablation devices and techniques, announces it has received CE Mark approval for the “EPi-Sense(TM) Guided Coagulation Device with VisiTrax®” for the treatment of cardiac arrhythmias, including atrial fibrillation. The EPi-Sense features first-of-its kind epicardial sensing electrodes designed to allow both electrophysiologists (EP) and cardiothoracic surgeons to map and navigate the epicardium and locate areas for linear epicardial ablation.

John Funkhouser, CEO, nContact, Inc., said, “The CE Mark approval of the EPi-Sense System, our 4th generation of coagulation devices, marks yet another milestone in our commitment to improve and evolve epicardial ablation tools and techniques for better access to the heart. Our goal is to create a new standard of care for treating cardiac arrhythmias. We believe epicardial ablation is critical to better clinical outcomes, and the new ‘hybrid’ device is designed for use by both EPs and surgeons.”

EPi-Sense further enhances the advantages of the Convergent Procedure, a closed chest, endoscopic technique enabled by nContact’s Numeris® Coagulation System with Visitrax®. The primary procedure advantages include visible access to the posterior of the atrium through a trans-diaphragmatic pericardial window (eliminating the need for chest incisions, ports, lung deflation or heart dissections), and the ability to create visible, non-conductive, linear lesions on a beating heart. With the new EPi-Sense device, EP mapping systems can locate the EPi-Sense ablation device in real time.

Additionally, the new embedded electrodes indicate when the EPi-Sense device is in contact with cardiac tissue. Consistent tissue contact assures the device is directed into the heart and avoids collateral tissue damage often associated with endocardial catheter ablation (where energy is directed outward from the atrium).

Prof. Borut Gersak, MD, PhD, Chief of Department of Cardiovascular Surgery at University Medical Center Ljubljana, Slovenia, commented, “The recently CE Mark Approved EPi-Sense with the addition of sensing electrodes is innovative and will be instrumental in allowing access to difficult areas of the heart, while improving ease of use for physicians and safety for patients. This technology in combination with the company’s unique closed chest cardiac access, or SUBTLE (sub-thoracic, totalendoscopic) approach, is obsoleting invasive bi-lateral thorascopic technologies, which are poorly designed for true minimally invasive ablation procedures.”

Dr. Paul Mounsey, BM BCh, PhD, Director of Cardiac Electrophysiology and Pacing, University of North Carolina, USA, commented on the hybrid nature of the new device, “The EPi-Sense is the first epicardial device that can be used by both EPs and surgeons to ablate epicardially utilizing sensors that allow electrical mapping.  Today, surgeons utilize the device to access and ablate the left atrium.  Soon, European studies will be underway that utilize the EPi-Sense to access the ventricle.  I suspect this device may quickly become a necessary part of the EP toolbox to better access epicardial areas not easily ablatable endocardially.”

The Epi-Sense System is scheduled to be commercially available throughout Europe in Q4 2011. For more information about nContact, Inc. or EPi-Sense, please visit www.ncontactinc.eu.  

The EPi-Sense System is currently not available in the U.S.

About nContact, Inc.

nContact, Inc. is the leading innovator in epicardial ablation devices and techniques, dedicated to transforming the underserved arrhythmia market through the advancement of less invasive, more efficacious ablation alternatives for cardiac arrhythmias such as atrial fibrillation (AF).

Its lead technologies, the EPi-Sense(TM) and Numeris® Coagulation System with VisiTrax® have CE Mark approval in Europe for the coagulation of cardiac tissue for the treatment of atrial fibrillation and atrial flutter.  

nContact has enabled treatment options by integrating epicardial ablation into the existing electrophysiologist technology platform. Among enabled physician advances is the Convergent Procedure; a unique, interdisciplinary procedure, combining epicardial and endocardial ablation techniques, which offers direct access to the heart via a completely closed-chest, SUB-thoracic TotaL Endoscopic (SUBTLE) approach.

The Numeris® Coagulation System with VisiTrax®, is also indicated for endoscopic coagulation of cardiac tissue in the United States.  nContact was founded in 2005 and is headquartered in Morrisville, North Carolina, U.S.A.

FOR INTERNATIONAL RELEASE ONLY

    Media Contacts
    Beth Rose               Kimberly Muscara
    nContact, Inc           The Ruth Group
    T +1(919)655-1566       T +1(646)536-7011
    brose@ncontactinc.com   kmuscara@theruthgroup.com

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