SpineGuard, an innovative company that develops and markets disposable medical devices that empower surgeons to enhance clinical outcomes and simplify surgeries, announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new PediGuard Threaded DSG device.
“We are very excited by the clearance of our PediGuard Threaded device, which brings a new generation of DSG-enabled probes to the US market, offering spine surgeons the added clinical benefit of reducing surgical steps in fusion surgery. This clearance allows our network of agents to initiate the commercial phase of this unique value proposition in a $7-billion market that is under price pressure and in tremendous need for differentiation,” said Stéphane Bette, co-founder, CTO and US general manager of SpineGuard.
Pierre Jérôme, co-founder and CEO of SpineGuard, concluded, “We have received very positive feedback on our new DSG device from our spine surgeon customers in Europe and Asia since its introduction earlier this year. We were eager to extend its benefits to surgeons, patients and hospitals in the US. In line with healthcare systems’ expectations of better clinical outcomes and surgical efficiency, SpineGuard continues to bring real-time digital technology to the operating room.”
The PediGuard Threaded device with DSG technology embedded inside may be used in open or minimally invasive approaches for pedicle screw insertion. It is available in various designs to accommodate surgeons’ preferences and patients’ anatomy. A single-use DSG pin embedded with the bipolar sensor is inserted into the cannula of the threaded shaft and connected to the electronic processor inside the single-use DSG handle. The distal tip of the threaded shaft includes an awl-like tip to facilitate redirection of the device until the tip is past the pedicle isthmus.