nContact has announced CE mark approval for its EPi-Sense guided coagulation device with VisiTrax for the treatment of cardiac arrhythmias. The EPi-Sense features first-of-its kind epicardial sensing electrodes designed to allow both electrophysiologists and cardiothoracic surgeons to map and navigate the epicardium and locate areas for linear epicardial ablation.
Borut Gersak, 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, 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 utilising sensors that allow electrical mapping. Today, surgeons utilise the device to access and ablate the left atrium. Soon, European studies will be underway that utilise 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.”
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.
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).
The Epi-Sense system is scheduled to be commercially available throughout Europe in the fourth quarter of 2011.
The EPi-Sense system is currently not available in the USA.