Israel’s business newspaper Globes is reporting that MAZOR Surgical Technologies has received approval from the FDA for the company’s combined SpineAssist navigation and C-Insight imaging system. As we have reported before, Mazor’s SpineAssist device is a miniature robotic guidance / perioperative planning system designed for treatments of spinal compression fractures and other vertebral surgical issues.
From the product pages:
The system consists of a miniature device that mounts above the patient’s spine, and a workstation running advanced surgical planning software.
SpineAssist’s software allows surgeons to perform 3D, CT- based preoperative planning on a personal computer at their own convenience prior to surgery.
Using a virtual catalogue of surgical implants, surgeons can view and position implants within each vertebra or disc on three planes: AP, lateral and axial. A special feature in the software is used to review the planning slice by slice in sequence.
The software supports a range of measurements including Cobb angle, lordosis and kyphosis. The surgeon can view a simulation of the correction they are planning, which is especially useful in deformity and scoliosis cases. The software also calculates rod length and curvature.
The SpineAssist workstation connects to a fluoroscopic C-Arm and performs automatic CT-to-fluoroscopy image registration based upon 2 fluoroscopic images. The workstation is used to control the precise motion of the miniature device to the preplanned position.
C-InSight is an add-on to existing C-Arms, converting 2D scans to 3D images intraoperatively.
In line with FDA guidelines for radiation reduction, C-InSight provides 3D images at radiation exposure levels as low as 5%-10% of other intraoperative 3D scans, making is safer for both the OR team and patients. C-InSight can often eliminate the need for a post-operative CT scan.
C-InSight quickly connects to any C-Arm with a video output (via BNC cable) and converts 2D scans to 3D images in 2 minutes.
A short in-service will get the OR technicians / staff ready to operate the C-InSight. The easy step-by-step instructions assure consistent performance.
Here’s Ori Hadomi, CEO of Mazor explaining the system on Fox Business News:
Demo video of C-InSight:
Globes: Mazor wins FDA nod for combined surgical systems…
Product pages: SpineAssist; C-InSight…
Flashback: SpineAssist Gets New FDA Approval