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.