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FDA Clears nContact, Inc.'s Cardiac Ablation Device, EPi-Sense®


1/17/2013 7:20:10 AM

MORRISVILLE, N.C.--(BUSINESS WIRE)-- nContact, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’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,” commented John Funkhouser, President of nContact, Inc.

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,” said Dr. Paul Mounsey, MD, Professor and Director of Electrophysiology at the University of North Carolina-Chapel Hill.

nContact will have the EPi-Sense® device available for review at the Boston Atrial Fibrilliation Symposium January 17-19, 2013, in Boston, MA at booth number 501. Commercial release of the device is scheduled for early 2013. For more information on EPi-Sense®, please visit our website at www.ncontactinc.com.

About nContact, Inc.

nContact, Inc. is the leading innovator in epicardial ablation devices and techniques. Its mission is to transform the underserved arrhythmia market through the advancement of less invasive, more efficacious ablation alternatives for cardiac arrhythmias.

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

The EPi-Sense® and Numeris® Coagulation Systems with VisiTrax® are 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.

Contact:

nContact, Inc

Beth Rose, 919-655-1566

brose@ncontactinc.com

or

Spectrum

Erin L. Turner, 202-587-2506

eturner@spectrumscience.com



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