SpineGuard and Zavation validated combined components for the DSG smart screw instrumentation, taking another step toward commercialization.
Here are five key notes:
1. The company was able to validate the technology in a Miami lab with a panel of spine surgeons in open and minimally invasive spine surgery.
2. SpineGuard is now positioned to manufacture the first series of smart screws for regulatory clearance and alpha launch.
3. The company received feedback from spine surgeons in the United States and is encouraged by their perspective. Plans to perform the first surgeries in Europe with the dynamically-guided screws are underway to take place by the end of the year in Europe.
4. Thomas Freeman, MD, a spine surgeon at the University of South Florida is using the DSG screw in a lab before the release. The screw is designed for surgery without a guide pin, and the surgeon can determine where the trajectory of the screw goes without fluoroscopy. Only one step is needed to place a screw, and it can be redirected if necessary.
5. Only three X-rays are used per screw, with 90 seconds from the time of skin incision to finish for two separate screws.
"We are performing increasingly complex procedures on our patients with superior outcomes that we could not have imagined even a decade ago," said Peter G. Gabos, MD, Co-Director, Spine and Scoliosis Center, Alfred DuPont Hospital for Children in Wilmington, Del. "With this increase in complexity, though, there is more potential risk. As spine surgeons, we have a responsibility to embrace any new technology that can help decrease risk to our patients. Dynamic Surgical Guidance does just that."