Becker's Spine Review

38 Executive Briefing embedded with a bipolar sensor that is inserted into the cannula of the Zavation Screwdriver/Pedicle Screw and connected to the electronic processor inside the single-use SpineGuard DSG handle. The combination of the Z-Direct Pedicle Screw System and DSG Technology creates a "smart screw," effectively reducing the steps of pedicle preparation before screw insertion. Here's how it works: • The distal awl-like tip of the DSG pin facilitates entry into the pedicle and the bipolar sensor continuously checks for the proximity of the cortical walls of the pedicle, alerting the surgeon of the potential for cortical breach. • The design of the Z-Direct screw tip allows for quick purchase of the screw into the pedicle and redirection during insertion until the screw is past the pedicle isthmus. "Rather than using fluoroscopy or image guidance, which have inherent errors associated with them, DSG guidance provides the surgeon feedback 'at-the-tip' of the screw to allow for moment-to-moment prediction of a potential breach, as well as the ability to adjust and redirect the screw at the optimal corridor of bone," says Larry Khoo, MD, of The Spine Clinic of Los Angeles. Additionally, surgeons often use a K-wire for guidance during MIS procedures, a multi-step process to guide instruments and implants into and through the pedicle. DSG Technology can eliminate K-wires, meaning surgeons need to take just one step for pedicle screw insertion. "Embedding DSG technology into a Zavation pedicle screw is novel and potentially game changing for surgeons performing minimally invasive spine fixation procedures. By combining these previously separate technologies, surgeons who wish to use a single-step pedicle screw insertion technique will have real-time navigation feedback, while eliminating multiple steps in the placement of these screws into the spine," says John Williams, MD, of SpineONE, a division of Ortho NorthEast in Fort Wayne, Ind. Dr. Khoo adds, "Rather than Jamshidi needles, K-wires, awls, taps — all of which require more time, risk and radiation exposure to perform MIS spine fusion procedures — DSG smart screw placement can be achieved in a single step without sacrifice in accuracy. The attendant gains in safety and bone purchase of the screw make the combination of these technologies even more attractive." The initial clinical results are in Drs. Khoo, Williams and Siddiqi are participating in a clinical study investigating how to reduce radiation and operative time per screw level during minimally invasive lumbar spine surgery. The study involves a prospective registry of cases leveraging DSG smart screw instrumentation. The researchers are examining the time of cannulation, radiation exposure, outcomes, complications and radiographic screw placement accuracy. The team is equipped with data from previously published studies on pedicle screw instrumentation placed with an open or MIS standard freehand technique. Dr. Khoo notes they will compare their findings with the data from these previous studies. "Although early, this DSG single-step screw placement technique appears to have savings in surgical time, radiation exposure and trajectory readjustments as compared to traditional MIS screw cannulation," Dr. Khoo says. Dr. Williams agrees, "Initial study results evaluating the benefit of combining DSG technology and pedicle screws show a reduction in both intraoperative radiation exposure as well as reduction in the time required to safely place a pedicle screw in the spine." The DSG enabled Zavation Z-Direct Pedicle Screw System can reduce the need for X-ray fluoroscopy lowering the risk of radiation exposure to the patient, OR staff and the surgeon. It also allows for ideal screw placement and enhanced bone purchase to optimize pedicle screw constructs. Combined with the potential to reduce the overall surgical process, hospitals have a unique opportunity to decrease costs for spine fusion procedures. "As familiarity and facility with the DSG-guided single- step screw placement technique grows, there will be resultant savings in radiation exposure, surgical time and bone purchase quality," adds Dr. Khoo. "I would anticipate a significant financial cost savings as the DSG smart screws are used more widely over time in any given surgical institution." n SpineGuard provides tools equipped with DSG™ (Dynamic Surgical Guidance) Technology to enhance spinal surgery. Devices built with DSG Technology give real-time audio and visual feed- back to improve the accuracy of pedicle screw placement, without the need for ancillary equip- ment. These devices have assisted spine surgeons in accurately placing pedicle screws in 60,000 spinal procedures around the world. Please visit www.spineguard.com for more information.

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