nContact Gains CE Mark for Fourth-Generation Epicardial Ablation System
August 23, 2011 — nContact Inc. has received CE Mark approval for the EPi-Sense Guided Coagulation Device with VisiTrax for the treatment of cardiac arrhythmias, including atrial fibrillation (AF). The EPi-Sense features 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.
The device further enhances the advantages of the Convergent Procedure, a closed chest, endoscopic technique enabled by nContact's Numeris Coagulation System with Visitrax. One procedural advantage includes visible access to the atrium posterior through a trans-diaphragmatic pericardial window (eliminating the need for chest incisions, ports, lung deflation or heart dissections). The device gives the ability to create visible, non-conductive, linear lesions on a beating heart. Also, EP mapping systems can now locate the device in real time.
Additionally, the new embedded electrodes indicate when the 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, M.D., Ph.D., 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."
Paul Mounsey, BM, BCh, Ph.D., director of cardiac electrophysiology and pacing, University of North Carolina 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 the fourth quarter of 2011. It is currently not available in the United States.
For more information: www.ncontactinc.eu