Atrial fibrillation: nContact wins FDA clearance for cardiac device

January 23, 2013 by MassDevice staff

nContact gets a nod from the FDA for its next-generation cardiac device with added sensing technology.

nContact logo

nContact said it's received FDA clearance for modifications made to its cardiac ablation device.

The Research Triangle Park, N.C.-based device medical device company won 510(k) clearance from the federal watchdog agency for the next generation of its VisiTrax cardiac ablation device, EPi-Sense. The company says this product includes new sensors, generating electrical feedback to assist electrophysiologists with device positioning during cardiac ablation procedures.

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Company officials said they plan to release the device for commercial sale in the U.S. early this year.

"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," said nContact president John Funkhouser in prepared remarks.

In 2010, nContact raised $16 million in a Series D round to dedicate to its cardiac ablation line, Numeris Coagulation with VisiTrax. The U.S. market for  cardiac rhythm management, electrophysiology and ablation devices in 2012 was valued at almost $6.8 billion, according to an iData Research report.