SpineGuard and Zavation announce first 20 successful cases performed in USA

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The first US cases using the “one-step” insertion of pedicle “smart screws” guided by SpineGuard’s Dynamic Surgical Guidance (DSG) technology have been successfully performed. The surgeries were performed successfully by eminent surgeons throughout the USA.

For SpineGuard and Zavation, who announced their co-development partnership in early 2015, these successful first surgeries performed after obtaining 510(k) clearance from the US Food and Drug Administration (FDA) are an essential milestone in preparation for the commercial launch of the Zavation pedicle screw instrumentation that integrates the DSG technology, a press release states.

“I knew immediately where the trajectory of the screw was going, even without fluoroscopy,” says Thomas Freeman, professor of Neurosurgery, Tampa, USA. “Rather than use five steps to put a screw into the spine, only one step was needed. I could redirect it easily if needed.”

“The procedures that we have performed with the self-guiding ‘Smart Screw’ technology have…reduc[ed] the probability of nerve and spinal cord injury and reduc[ed] radiation exposure to patients and hospital staff,” adds Farhan Siddiqi, assistant professor, University of South Florida, Trinity Spine Center, Florida Advanced Spine, Sports, and Trauma Centers, Tampa, USA.

Victor Hayes—an orthopaedic surgeon at the Trinity Center in Tampa—offers high praise for the system, saying, “The DSG technology will change the way spine surgery is performed. It will allow us to place spinal instrumentation faster, safer and with greater accuracy minimising the risks to our patients.”

“Integrating the DSG technology with pedicle screws will greatly optimise…workflow and accuracy, and reduce radiation exposure for surgeons in both the traditional and minimally invasive spinal surgical settings. Not only will the ‘smart screw’ allow for active real-time guidance and breach-avoidance through the pedicle, but it will also provide unprecedented feedback and confidence in the ultimate fixation of the screw itself,” adds Larry Khoo, neurosurgeon at The Spine Clinic, Los Angeles, USA.

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