FDA clears EPi-Sense cardiac ablation device with embedded sensors


The US Food and Drug Administration (FDA) has given clearance to nContact for its new version of EPi-Sense cardiac ablation device 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 to follow epicardial device positioning and lesion creation in real time by utilising 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.

“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,” said Paul Mounsey, professor and Director of Electrophysiology at the University of North Carolina-Chapel Hill, USA.

The company announced that commercial release of the device is scheduled for early 2013.

The EPi-Sense with VisiTrax has CE mark approval in Europe for the coagulation of cardiac tissue for the treatment of atrial fibrillation and atrial flutter.

The EPi-Sense with VisiTrax is indicated for endoscopic coagulation of cardiac tissue in the United States.