SpineGuard has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new PediGuard Threaded DSG (Dynamic Surgical Guidance) 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,” says Stéphane Bette, co-founder, chief technical officer and US general manager of SpineGuard.
Pierre Jérôme, co-founder and chief executive officer of SpineGuard, concludes, “We have received very positive feedback on our new DSG device from our spinal 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 USA. 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 is designed to 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 intended to facilitate redirection of the device until the tip is past the pedicle isthmus.