SpineGuard has reported that it has received FDA 510(k) clearance for three new products—two miniaturised versions of its classic and curved range and a directional version of its cannulated series—in its Pediguard platform.
Pedicle screw-based stabilisation has become the gold standard for treating spinal instabilities and deformities. This market is growing due to the increasing number of patients requiring surgical treatment and a larger number of surgeons being trained in pedicle screw-based technologies. Technological advancements such as minimally invasive surgery, bone substitutes, dynamic stabilisation and thoracic screws further reiterate the importance of pedicle screw placement.
Pierre Jérôme, co-founder and chief executive officer of SpineGuard, said: “This new product-development milestone now empowers SpineGuard to assist surgeons in the most challenging clinical situations in spine, and fortifies our potentially game-changing technology in the US market.”
“The addition of a miniaturised Pediguard sensor opens the door to multiple new potential small-size applications of our platform, such as drill bits, guide wires or implants,” added Stephane Bette, co-founder and chief technology officer of SpineGuard.