- ClaroNav, a surgical navigation system leader with a strong track record of growth or innovation.
- Navient is now cleared in over 20 countries, allowing us to support our global network of distributors.”
ClaroNav is satisfied to announce that its CKI subsidiary has received Class III medical device approval from Health Canada for its Navient ENT and Navient Cranial. Both devices had previously received Class II approval.
Navient, a computer-assisted surgical navigation system, functions similarly to a GPS for the surgeon to navigate inside the patient’s skull. It provides three-dimensional visualization and aids surgeons in navigating their way inside the patient’s sinuses while avoiding critical structures such as the optic nerve or brain while safely navigating their way to the diseased area.
“This updated clearance is critical for Navient systems, which are used for critical life-saving surgeries,” says CKI CEO Ahmad Kolahi. “Regulatory agencies around the world continue to focus on improving patient safety, and at ClaroNav, we strive for maximum compliance at all times.”
Navient Cranial is planned for use in transcranial procedures. A brain tumor is an abnormal growth of brain cells. Every year, over 2 million brain masses are removed around the world.
A surgical navigation system is a standard of care for cranial procedures because it allows for minimally invasive surgery, improves surgical accuracy, reduces tissue damage, and shortens recovery time.
Navient ENT is designed for trans-nasal procedures. Sinusitis is an inflammatory syndrome that affects the sinuses, which are air-filled cavities in the skull.
Sinusitis is one of the most same human diseases; approximately 29 million Americans are affected by the chronic form of rhinosinusitis, with an annual direct cost of more than $4 billion. Endoscopic sinus surgery is performed on approximately 500,000 of these patients. The surgery’s goal is to restore ventilation and drainage while protecting the mucosa.