FDA Approves Spinal Tether Device to Correct Idiopathic Scoliosis

August 16, 2019
Kenny Walter

Kenny Walter is an editor with HCPLive. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with R&D Magazine. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

The Tether-Vertebral Body Tethering System will help treat the most common form of idiopathic scoliosis.

The first ever spinal tether device will treat idiopathic scoliosis in children and adolescents who do not respond to conservative treatment like external bracing, after receiving US Food and Drug Administration (FDA) approval.

The Tether-Vertebral Body Tethering System, developed by Zimmer Biomet Spine, is designed to treat growing children and adolescents between 10-18 years old whose spinal curves are approaching or have reached the range where surgical treatment is a viable 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, PhD, director of the Office of Orthopedic Devices in the FDA's Center for Devices and Radiological Health, said in a statement. “Today's approval provides access to a new treatment option that could improve quality of life for patients with idiopathic scoliosis.”

According to the FDA, approximately 6,800 patients in the US develop progressive curvatures annually that do not respond to bracing.

The new spinal tethering device, which includes anchors and vertebral body screws on the same side of each vertebra with a flexible cord, is designed to correct the user’s curvature while allowing a fuller range of motion when compared to spinal fusion procedures.

The device works by applying tension to the tether cord during surgery to compress 1 side of the side, partially correcting the curve. Over time, the tether slows growth on the curved side of the spine, promoting growth on the opposite side.

The FDA reviewed data for The Tether — Vertebral Body Tethering System through the humanitarian device exemption (HDE) process, a program for devices intended to benefit to patients by treating or diagnosing a disease or condition that affects not more than 8,000 individuals in the US per year.