Canadian medical device company ClaroNav said yesterday it won FDA 510(k) clearance for its NaviENT surgical navigation system designed for endoscopic sinus surgery and skull base surgery, with plans to launch in the coming months.
The NaviENT is designed as an image-guided surgical navigation system to help otolaryngology-specific surgeons identify anatomic structures in transnasal interventions and avoid complications by making more informed decisions during procedures, the company said.
“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. However, despite its obvious advantages, many surgeons are hesitant in adapting the technology, blaming its cumbersome operation and high price tag. NaviENT is an innovative navigation system designed in close collaboration with experienced rhinologists to address shortcomings of the current navigation systems. Our primary goal is to offer an intuitive, accurate and affordable state-of-the-art ENT navigation system and make it standard-of-care in the ENT field,” ClaroNav Kolahi CEO Ahmad Kolahi said in a prepared statement.
ClaroNav said that previous studies have indicated that navigation systems allow for more complete dissection and reduce the need for revision surgeries.
“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. 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,” Dr. Peter Catalano of Boston’s St. Elizabeth’s Medical Center said in a prepared release.
