First-of-its-Kind Device Granted FDA Approval for Treatment of Pediatric Scoliosis

This week the FDA approved an innovative device called a spinal tether for the treatment of progressive idiopathic scoliosis. The Tether – Vertebral Body Tethering System is for use in children and adolescents for whom conservative treatments have been unsuccessful, and in whom spinal curve have reached or are approaching the point at which surgery is deemed appropriate.

Scoliosis is the most common spinal deformity in children. It is a sideways curvature of the spine that most commonly develops when children are between the ages of 10 and 18. Though external bracing can sometimes help, almost 7,000 patients in the United States end up needing surgery.

Traditionally these children have required spinal fusion, which improves their curvature but often leads to long-term complications such as arthritis or future spinal deformities later in life. The new FDA-approved device offers an entirely different option in which the curvature is corrected while the spine maintains a better range of motion.

The new device is inserted through an incision on the side of the patient’s chest rather than the back, and works by attaching anchors and screws into the side of each vertebrae in the curved section. Those screws and anchors are attached to a flexible cord, and pressure is applied to that tether during surgery to correct the curve.

As time passes the curvature is not only slowed, but growth on the opposite side is optimized. The combination of these two dynamics leads to additional curve correction as the young patient continues to grow. The device is left in place permanently unless problems develop.

Patients who undergo the tethering procedure are monitored over time, undergoing diagnostic scans that watch out for overcorrections or other problems. Patients for whom the procedure is unsuccessful can still choose to have spinal fusion surgery, though the FDA’s review process determined that after two years of testing, patients undergoing the tethering procedure experienced significant improvement without adverse events outside of those expected from any spinal surgical procedure.

The device is manufactured by Zimmer Biomet Spie, which will be developing a patient data registry to monitor the long-term success of procedures utilizing the device.

Zimmer Biomet Spine has shared with the FDA that it will be partnering with the Harms Study Group, a cohort of surgeons dedicated to the advancement of treatment for children and adolescents with spinal deformities, to develop a patient data registry to help assess the long-term performance of The Tether System.

Speaking of the device, FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. said,

The FDA continues to collaborate with stakeholders to encourage the development of registries, including the one being developed for this device, as an additional tool to gather and track real world evidence. This type of post-market data generation can provide ongoing device safety surveillance and additional evidence for effectiveness. More broadly, real world evidence can help support innovative developments while ensuring that patient health and safety remains the top priority.”

If you or your child has been diagnosed with a spinal curvature and you need information on your options, contact our spine specialty practice in New Jersey to set up an appointment.

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