FDA OK’s VUZE Medical’s VUZE System for Spine Surgery

VUZE Medical, a company specializing in image guidance and verification for minimally invasive spine surgery, earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its VIZE system. The software-only solution uses proprietary image processing to overlay graphical representation of tools seen in intra-op 2D images onto axial and sagittal views generated from a patient’s standard pre-op 3D scan. It is to be used during common spinal stabilization procedures performed in outpatient or ambulatory settings.
 
The system’s hardware includes an on-cart, off-the-shelf PC and only requires 2D standard X-ray imaging in the OR. It uses no sensors, cameras, or reference arrays and doesn’t need calibrations or lines of site. It can be used with standard surgical tools and implants without add-ons or modifications. The system also offers pre-op surgical planning, including implant sizing, entry location, trajectory determination, intra-op guidance, and tool trajectory/position confirmation.
 
First patient cases were successfully performed at Israel’s Ranbam Medical Center.
 
“Our early experience has demonstrated very high surgical accuracy and the VUZE System is proving to be extremely useful,” Dr. Ory Keynan, who performed one of the cases, told the press. “Furthermore, we believe that the VUZE System will enable us to perform a broader range of surgeries in a minimally-invasive manner.”
 
Over three million spinal stabilizations are performed yearly worldwide, with a third of those in the U.S.¹ These include vertebral fixation with pedicle screws, vertebral fixation coupled with fusion, and vertebral augmentation with synthetic or biological cement. About 80 percent of stabilizations treat short spinal segments.¹ Short-segment surgeries are often done manually and only assisted by 2D X-ray.
 
“VUZE Medical was founded to address a technology gap in guiding short-segment spinal interventions. We are aiming to preserve the advantages of common X-ray guidance while addressing its shortcomings,” said David Tolkowsky, VUZE Medical’s CEO. “Rising cost pressures and a growing aversion towards hospitalization in the age of COVID-19 are accelerating a shift of short-segment surgeries from inpatient to outpatient and from outpatient to ambulatory settings. In such settings, reliance on X-ray guidance is particularly high. We believe this will be the greatest opportunity for our system.”
 
Reference
¹ Orthopedic Network News: 2020 Spinal Surgery Update