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Zimmer Biomet Gains FDA Approval for Tether Scoliosis Treatment -

Zimmer Biomet received FDA approval for The Tether™, an anterior vertebral body tethering system for the treatment of pediatric idiopathic scoliosis that has not responded to conservative treatment (e.g. bracing). The action represents the first approval order for a Humanitarian Use Device in spinal pediatrics within the last 15 years. The Tether offers an alternative to fusion, though for patients who do not adequately respond to the treatment, fusion is still possible. Using an endoscopic, minimally invasive approach, a flexible cord is placed along the vertebrae in the curved section of the spine. The cord pulls on the outside of a scoliosis curve to initially straighten the spine, while the inside of the curve is left free to grow. The system is not intended for removal barring the development of issues such as overcorrection. The company and FDA are finalizing a clinical study to monitor patient outcomes, and Zimmer Biomet will partner with the Harms Study Group to develop a patient data registry to assess long-term performance of The Tether System. Harms represents a global cohort of surgeons dedicated to the advancement of treatment for children and adolescents with spinal deformities. (Zimmer Biomet, Inc. and FDA, 8/16/19)