Becker's Spine Review

37 Executive Briefing Sponsored by: S pine surgery is among the costliest procedures in healthcare today, and providers across the country are examining evidence-based practices to achieve high-quality outcomes while lowering the economic burden. Spine fusion cases often require pedicle screw placement, in which the surgeon uses a four-step process: access the pedicle using a drill or awl; create a reproducible trajectory using a probe; tap the pedicle to help guide the screw in the bone; and then place the pedicle screws. This multi-step, multi-instrument process takes time, and each step frequently uses significant amounts of X-ray fluoroscopy to validate placement of each instrument to confirm optimal trajectory for final screw placement. However, surgeons are turning to minimally invasive procedures to achieve better results, creating a need for medical device innovation. The minimally invasive advantage Every minute a patient spends in the operating room increases the risk of infection and adds cost to spine fusion procedures. When surgeons perform MIS fusion procedures and reduce procedure time, they're able to consistently achieve better clinical outcomes and drive cost savings for the hospital. A 2016 study published in Spine assessed the quality and economic impact of minimally invasive versus open transforaminal lumbar interbody fusion and posterior lumbar interbody fusion. Compared to the open group, patients in the MIS group reported less blood loss and shorter lengths of stay. Additionally, researchers found the MIS group saw comparative cost savings from 2.5 percent to 29.3 percent. Technavio analysts predict the global MIS spine market will grow at a compound annual rate of 7-plus percent through 2020. In the U.S. specifically, the report notes an increase in lumbar spine fusion cases through 2020. The MIS technique presents some major drawbacks, however: Spine surgeons greatly depend on X-ray fluoroscopy and other intraoperative radiographic technologies during minimally invasive spine fusion procedures, which can result in increased surgical time and increased radiation exposure for the patient, OR staff and the surgeon. "In an attempt to reduce the invasiveness of surgery, we have to rely on X-ray guidance in order to perform the operation through very small incisions," says Farhan Siddiqi, MD, assistant professor at Tampa-based University of South Florida and a surgeon at Tampa- based Florida Advanced Spine, Sports and Trauma Centers and Odessa, Fla.-based Trinity Spine Center. A 2016 study published in Clinical Spine Surgery examined the radiation-related risks of minimally invasive transforaminal lumbar interbody fusion compared to open surgery. The 619-patient study found the minimally invasive TLIF patients experienced a 2.4- fold increase in radiation exposure rate compared to open patients. Enter the Zavation Z-Direct Pedicle Screw System featuring SpineGuard's Dynamic Surgical Guidance Technology (DSG™). The hybrid technology is the result of a 2015 co-development partnership between the companies. SpineGuard and Zavation worked together to develop a "SmartScrew" designed to streamline surgical steps while maintaining the accuracy for pedicle screw placement. Additionally, it's showing promise to reduce the use of intraoperative imaging in standard and MIS procedures. In October 2017, the two companies commercially released the screw system in the U.S. during the North American Spine Society annual meeting in Orlando, Fla. Why smart screws are the smart choice SpineGuard's DSG Technology differentiates various tissue types based on an analysis of the local electrical conductivity (cancellous bone, cortical bone, blood and soft tissues). Real-time feedback informs the surgeon of changes in tissue type by changes in the pitch and cadence of an audio signal and a flashing LED light. This in turn alerts the surgeon of potential pedicular or vertebral breaches during pedicle screw placement. The DSG enabled Z-Direct Pedicle Screw System incorporates a single-use SpineGuard DSG pin SmartScrew Technology Reduces Radiation Exposure and OR Time in MIS Lumbar Surgery

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