SpineGuard has secured approval from the US Food and Drug Administration (FDA) for its new DSG (dynamic surgical guidance) integration module for making pedicle screws smart.
The firm’s module can be used in combination with Zavation’s spinal fusion system to make advanced pedicle screws.
DSG-enabled screw, which is a combination of bipolar sensor and pedicle screw, eliminates the use of k-wire in minimally invasive surgery.
The technology will provide surgeons with real-time guidance, as well as enables to insert the screw directly into a vertebra without drilling a pilot hole.
Based on the analysis of the local electrical conductivity, the DSG sensor can differentiate various tissue types, including cancellous bone, cortical bone, blood and soft tissues.
According to the company, real-time feedback allows the surgeon to change tissue type based on an audio signal varying in pitch and cadence.
Other DSG-enabled SmartScrew, which was co-developed with Neuro France Implants, is currently in alpha launch in Europe.
SpineGuard CEO and co-founder Pierre Jérôme said: “This FDA clearance will allow US spine surgeons to insert pedicle screws ‘with a DSG enabled device’ not only in just one step but also with confidence, hence further securing and streamlining the most commonly performed instrumented spinal procedure, fusion.
“We are thrilled to immediately begin supplying Zavation, our US partner, with our DSG integration module and look forward to working with our combined networks for the introduction of the first DSG-enabled pedicle screw in the US market.”
SpineGuard co-founder, CTO and US general manager Stéphane Bette said: “DSG enabled devices offer a new paradigm to pedicle screw manufacturers who wish to differentiate their products from the rank-and-file screws in the market today.”
Image: DSG-enabled smart screw system. Photo: courtesy of SpineGuard.