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.
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.