Study Claims Increased Safety With Robotic Guidance System

According to a recent international study, the use of the Renaissance guidance system from Mazor Robotics Ltd. provides greater reliability in screw placement and reduced use of fluoroscopy.

Fluoroscopy provides real-time X-ray imaging for guiding a variety of diagnostic and interventional procedures. Though the X-ray exposure needed to produce one fluoroscopic image is low (compared to radiography, for example), high exposure to patients can result from the number of images used in fluoroscopic procedures. As a result, the total fluoroscopic time is an important factor in determining patient exposure from fluoroscopy.

The study, cited in a release from the company, was published in the current issue of Turkish Neurosurgery.

Caesarea, Israel-based Mazor Robotics’ Renaissance guidance technology is an intra-operative 3-D imaging system that is an add-on to C-arms (operating room imaging systems), and is designed for use in spine and brain surgery. Renaissance, is cleared by the U.S. Food and Drug Administration and CE marked for spine and brain surgery.

The research was led by Dr. Mehmet Resid Onen, Umraniye Training and Research Hospital, Department of Neurosurgery, Istanbul, and reviewed 27 patients who underwent thoracolumbar stabilization operations aided by Renaissance at the hospital during 2012-2013. The accuracy rate of pedicle screw positioning with the system was found to be 98.5 percent, and no neurological, vascular or dural damage was observed in the case series.

According to the investigators, while the use of percutaneous instrumentation holds a superior advantage over open procedures, the localization and orientation of percutaneous placed implants are completely dependent on the use of fluoroscopy. With the Renaissance system, an average of only 1.3 seconds of fluoroscopy was used per screw and 40 percent of patients’ implants were instrumented percutaneously.

The study noted that the total surgery duration in patients who undergo multi-level instrumentation is reduced because of the decrease in the time that is typically lost in gaining X-ray images to determine the screw location.

“This data shows how the benefits of utilizing the Renaissance system support the shift in healthcare toward providing better care for patients that translates into overall population health improvement,” said Mazor Robotics CEO Ori Hadomi. “And by reducing the chance of error and revision procedures, our goal is to provide real value to the hospital system by helping to reduce unnecessary costs.”

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