FDA Clears nContact’s Device

FDA Clears nContact’s Device

EPi-Sense with embedded sensors allows physicians to direct Epicardial Ablation on atrium and create lesions on ventricle.

January 27, 2013
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The U.S. Food and Drug Administration (FDA) has cleared nContact Inc.’s modifications to its VisiTrax cardiac ablation device, EPi-Sense, now with embedded sensing capability. This next generation of technology includes sensors along the ablation device, which provide real-time feedback to physicians conducting cardiac ablation procedures.

The EPi-Sense device and its sensing technology allows electrophysiologists (EPs) to follow epicardial device positioning and lesion creation in real time by utilizing navigational mapping. From a safety perspective, the sensors use electrical feedback to ensure the device is properly positioned on cardiac tissue and energy is directed into the heart. Additionally, by using the sensors during epicardial ablation, the ablated tissue’s electrical impulses can be measured to predict lesion completeness before repositioning the device.

“The EPi-Sense is another step forward in advancing epicardial ablation techniques to address limitations of other ablation devices, potentially creating a better experience for physicians, and ultimately, patients,” comments John Funkhouser, president, nContactInc.

nContact, a leading manufacturer of cardiac tools to treat arrhythmias, has pioneered the use of a multi-disciplinary, closed chest approach to ensure lesion completeness that interrupts electrical signals that cause arrhythmias. The Company’s reputation for advancing technology in the epicardial ablation space is further enhanced by this technology innovation.

“Throughout the Company’s short history, their engineers have consistently innovated and improved devices for epicardial ablation, especially for the treatment of arrhythmias in patients with enlarged and diseased atria. This has allowed physicians and surgeons to work together to address and treat arrhythmias in patients with the most complex heart disease,” states Dr. Paul Mounsey, MD, Professor and Director of Electrophysiology at the University of North Carolina-Chapel Hill.