Zimmer Biomet Gets FDA Nod for First Pediatric Spinal Tether Device
FDA has approved Zimmer Biomet’s Tether Vertebral Body Tethering System, the first of its kind treatment for idiopathic scoliosis. Designed for pediatric patients who have idiopathic scoliosis (the most common type of scoliosis), the device treats growing children and adolescents with spinal curves that have not responded to conservative treatment. In these cases, the patients have approached or reached a range in which surgical treatment is an option. The Tether device provides a fusion-less option.
“For children and adolescent patients with idiopathic scoliosis that does not respond favorably to bracing, treatment options have been limited to fusion surgeries,” said Capt. Raquel Peat, Ph.D., director of the Office of Orthopedic Devices at CDRH, in an FDA press release. “Today’s approval provides access to a new treatment option that could improve quality of life for patients with idiopathic scoliosis.”
FDA reviewed the device through the humanitarian device exemption process.
The Tether system involves an incision on the side of the chest through which the placement of anchors and vertebral body screws is made into the same side of each vertebra in the curved section of the spine. A flexible cord (the tether) is connected to the screws, and over time, the tether slows the growth on the curved side of the spine to encourage growth on the opposite site.
“Often growth in children with scoliosis results in curve progression. With AVBT, that growth can be harnessed to gradually further correct the tethered portion of the spine. The Tether provides clinicians who take care of children with spinal curves another option for treatment. When utilized in the appropriately selected patient, the results are dramatic with respect to curve control and maintenance of a mobile spine.” – Dr. Amer Samdani, board-certified neurosurgeon and Chief of Surgery for Shriners Hospitals for Children in Philadelphia
The device is not intended to be removed unless issues such as overcorrections develop. FDA is encouraging the development of a registry that enables tracking of real-world evidence to provide ongoing safety surveillance information for the device. Zimmer Biomet and the agency are finalizing a new clinical study for The Tether to monitor patient outcomes.
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