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Zimmer Biomet Holdings Inc. announced it has received FDA approval for The Tether, the first spinal tether device intended for use in children and adolescents to correct idiopathic scoliosis that has not responded to conservative treatment.
“For children and adolescent patients with idiopathic scoliosis that does not respond favorably to bracing, treatment options have been limited to fusion surgeries,” Capt. Raquel Peat, PhD, director of the Office of Orthopedic Devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “Today’s approval provides access to a new treatment option that could improve quality of life for patients with idiopathic scoliosis.”
Available through the FDA’s humanitarian device exemption pathway, The Tether is an anterior vertebral body tethering solution that uses a strong, flexible cord instead of metal rods to pull on the outside of a scoliosis curve to initially straighten the spine while the inside of the curve is left free to grow, according to a company press release.
Clinical data presented to the FDA from 57 patients who received The Tether showed sufficient improvement of the curvature of the spine in 43 patients at 2 years. Overcorrection of the curvature, tether breakage and pneumothorax were reported as the most common serious adverse events, according to results, while pain, respiratory problems, nerve injuries and bleeding were reported as general complications consistent with any spinal surgical procedure.
“The Tether embodies Zimmer Biomet’s mission to improve the quality of life for people around the world. This collaboration demonstrates how a focused, shared purpose can fundamentally change the way we approach treatment of diseases like scoliosis,” Jim Cloar, president of Zimmer Biomet Spine, said in the release. “Working together, clinicians, the FDA and Zimmer Biomet have given surgeons an important fusion-less scoliosis treatment option for their pediatric patients. This procedure gives kids the best option for maintaining spine mobility and reaching their full potential.”
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