Israel’s Globes newspaper reports that Mazor Surgical Technologies Ltd. “has obtained US Food and Drug Administration (FDA) approval to extend the application of the company’s SpineAssist imaging and robotic device for assisting in spinal surgical procedures.” According to the newspaper, the use of Mazor’s SpineAssist device, a miniature robotic guidance system designed for treatments of spinal compression fractures and other vertebral surgical issues, has now been extended by the FDA for the cervical, in addition to thoracic and lumbar regions.
More about the device, from company’s website:
The SpineAssist system enables surgeons to accurately place implants with reduced radiation exposure during surgery.
The system consists of a miniature device that mounts above the patient’s spine, and a workstation running advanced surgical planning software.
A wide range of spinal surgeries require the placement of implants, such as spinal fusion, kyphoplasty and translaminar facet fixation.
Accurate implant placement is required as implants are placed close to the spinal cord, branching nerve roots, and major blood vessels. In addition, accurate placement will ensure the highest probability of surgical success.
Today, implant placement is mostly accomplished through freehand techniques, and depending on the technique and/or complexity of the case, may require a large number of fluoroscopic (x-ray) images to ensure accuracy of placement.
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.
The SpineAssist uses miniature robotic technology and is the size and shape of a soda can.
The miniature device is secured on a platform: The Hover-T™ for minimally invasive single or multi-level procedures or a clamp and bridge for open procedures.