NaviENT Receives FDA 510(K) Clearance
September 21 2017 - 9:00AM
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.
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
About ClaroNavClaroNav 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.
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ClaroNavAhmad Kolahi, 647-951-1525CEOinfo@claronav.com