ClaroNav's NaviENT Nabs FDA 510(K) Clearance
Published: Sep 22, 2017
TORONTO--(BUSINESS WIRE)--ClaroNav, a leader in surgical navigation systems, is pleased to announce that it has received FDA 510(K) clearance from the Food and Drug Administration (FDA) to market and sell NaviENT in the United States. NaviENT had previously been granted CE mark for the European market and Health Canada approval in 2016.
“Our primary goal is to offer an intuitive and smart solution to enhance surgeon productivity during inpatient and outpatient FESS and skull base surgeries.”
NaviENT, a computer-assisted surgical navigation system, is like a GPS for the surgeon to navigate inside the patient skull. It provides three-dimensional visualization and assists surgeons with finding their ways inside the patient sinuses and avoid critical structures such as the optic nerve and brain, while safely navigating their way to the diseased area.
Sinusitis is inflammation of the sinuses, which are air-filled cavities in the skull. Sinusitis is one of the most prevalent of human diseases, about 29 million Americans are affected by the chronic form of the rhinosinusitis disease with annual direct cost of over 4 billion dollars. Approximately 500,000 of these patients undergo an endoscopic sinus surgery procedure. The goal of the surgery is to restore ventilation and drainage while preserving mucosa.
NaviENT is a 3D mapping system that combines CT scans and real-time information about the exact position of surgical instruments using a stereoscopic optical tracking system. In this way, surgeons can navigate their surgical instruments through complex sinus passages and provide surgical relief more precisely. Study shows that surgical navigation systems would allow more complete dissection, obviating the need for revision surgery, and results in cost saving. The American Academy of Otolargyngology (AAO-HNS) endorses the use of image-guided surgery for many endoscopic sinus surgeries.
“Surgical navigation system is a precious aid in primary surgery and its benefits are widely accepted among neurosurgeons and otolaryngologists. Its 3D anatomical structure localization and visualization capability assists the surgeons to target specific anatomy and avoid complications in highly variable sinus anatomy,” said Ahmad Kolahi, CEO of CKI, a subsidiary of ClaroNav. “Our primary goal is to offer an intuitive and smart solution to enhance surgeon productivity during inpatient and outpatient FESS and skull base surgeries.”
Additional information: www.claronav.com/navient
ClaroNav is a medical device hardware and software company headquartered in Toronto, Canada, and is represented worldwide by authorized distributors. ClaroNav is dedicated to innovation and developing state-of-the-art surgical navigation systems.