Technology | Procedure Navigation Systems | September 13, 2017

ClaroNav Receives FDA 510(k) for NaviENT Surgical Navigation System

Image-guided surgical navigation system designed to help ENT surgeons identify anatomic structures in transnasal interventions

ClaroNav Receives FDA 510(k) for NaviENT Surgical Navigation System

September 13, 2017 — ClaroNav announced that it has received U.S. Food and Drug Administration (FDA) 510(K) clearance to market and sell NaviENT in the United States. NaviENT is an image-guided surgical navigation system, which helps ear-nose-and-throat (ENT) surgeons with identifying anatomic structures in the transnasal interventions. It enables surgeons to avoid complications and confidently make more informed decisions during FESS and skull base surgeries. NaviENT also results in cost saving by shortening length of hospitalization compared to non-navigated surgeries.

Over the coming months the company will offer the product for sale to hospitals, clinics and offices performing endoscopic sinus surgery and skull base surgery in the U.S. NaviENT had previously been granted CE mark for the European market and Health Canada approval in 2016.

Study shows that surgical navigation systems would allow more complete dissection, obviating the need for revision surgery. The American Academy of Otolargyngology – Head and Neck Surgery (AAO-HNS) endorses the use of image-guided surgery for many FESS and skull base procedures.

“NaviENT was designed in concert with rhinologists to develop the most user-friendly, accurate, reliable and affordable navigation system on the market. It is clear that they have achieved their goals. In this case, using is believing,” said Peter Catalano, M.D., FACS, FARS, professor of otolaryngology, chief of otolaryngology, St. Elizabeth’s Medical Center, Boston. “NaviENT is a most welcome addition for the ENT surgeon. This portable system provides quick set-up and accurate registration, a user-friendly interface, and versatile re-usable intra-operative tools. In addition, there are no disposable costs and the sale price is extremely affordable. NaviENT will effectively bring surgical navigation to every corner of the globe.”

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