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FDA Approves Spinal Tether Device to Correct Idiopathic Scoliosis
The spinal tether device has been approved for children and adolescents with idiopathic scoliosis, the most common form of spinal deformity.
The device is intended for patients who has not responded to conservative treatments, such as external bracing.
Nearly 7000 patients in the US has progressive spinal curvatures annually.
Designed to treat growing children and adolescents between 10-18 years old whose spinal curves are approaching or have reached the degree where surgical treatment is a viable option.
This system consists of anchors and screws surgically placed into vertebrae on the curved section of the spine.
A flexible tether is attached to the screws are used to compress the curved side of the spine during surgery.
With growth, tension in the tether increases to further correct spinal alignment.
Over time, the tether slows growth on the curved side of the spine, promoting growth on the opposite side.
Complications: over correction of spinal curvature, tether breakage, pneumothorax, pain, respiratory problems, nerve injuries, and bleeding.