The US Food and Drug Administration has issued 510(k) clearance for SpineGuard’s new Dynamic Surgical Guidance(DSG) integration module to be used with Zavation’s spinal fusion system.
The addition of the DSG module will enhance performance of the pedicle screws, making them 'smart'.
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.”
A DSG-enabled screw is a combination of a bipolar sensor and a pedicle screw within one device, offering real-time guidance to surgeons and allow direct insertion of the screw into a vertebra without drilling a pilot hole.
Additionally, in minimally invasive surgery, it eliminates the need for a k-wire.
The DSG sensor helps in classifying various tissue types such as cancellous bone, cortical bone, blood and soft tissues, by analysing the local electrical conductivity.
It then sends real-time information to surgeons on the changes in tissue type by an audio signal varying in pitch and cadence, alerting them of potential breaches during pedicle screw placement and allows for screw redirection.
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.
“We are extremely pleased that our first DSG-partner in the USA is Zavation, and we look forward to extending this technology platform to other players in the industry."
Image: DSG-enabled smart screw system. Photo: courtesy of SpineGuard.