SpineGuard wins FDA nod for PediGuard threaded DSG device.

SpineGuard  (EPA:ALSGD) said today it won FDA 510(k) clearance for its PediGuard threaded Dynamic Surgical Guidance device designed for pedicle screw insertion. The PediGuard device is available in various designs, the company said, to accommodate both surgeon’s preferences and patient anatomies. “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,” CTO Stéphane Bette said in a press release. In procedures, the device’s single-use DSG pin embedded with a bipolar sensor is inserted into the cannula of the threaded shaft and connected to the electronic processor inside the DSG handle, the company said. The distal tip of the shaft includes and awl-like tip to allow for redirection of the device until the tip is past the pedicle isthmus. “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 ef...
Source: Mass Device - Category: Medical Equipment Authors: Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Spinal SpineGuard Source Type: news