The FDA has expanded the clearance of NuVasive’s limb-lengthening system to include bone transport, a method that allows an orthopedic surgeon to regenerate bony tissue to fill a space where bone is missing.
NuVasive picked up the Precice system, along with a spinal bracing and distraction system, in its 2016 acquisition of Ellipse Technologies. The Precice system was originally cleared for the treatment of patients with differing limb lengths and limb deformities.
The system comprises an implant placed in the soft medulla of the femur or tibia and an external remote controller that is used to compress and distract the bones. The system uses the magnetic interaction between the implant and controller to lengthen bones.
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The expanded clearance allows the system to be used in bone transport, which regenerates tissue to repair areas of bone loss that occurs due to infection or trauma, the company said in a statement. The system may now be used for open and closed fracture fixation, pseudoarthritis, malunions—where a fracture doesn’t heal properly—and nonunions, where broken bones do not heal.
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"This FDA 510(k) clearance of PRECICE for expanded indications, including bone transport, demonstrates the evolving innovative capabilities of our technology to transform and expand the limb reconstruction and trauma markets," said Massimo Calafiore, president of NuVasive Specialized Orthopedics, in the statement. "NSO remains committed to providing trauma surgeons with proper solutions to treat unmet clinical needs and challenging fractures. This allows us to treat more patients suffering from debilitating segmental bone defects through the use of PRECICE in bone transport procedures."