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FDA Approves New Device To Treat Idiopathic Scoliosis


One of the most common spinal deformities affecting children and adolescents during growth is idiopathic scoliosis. External bracing is a standard treatment for idiopathic scoliosis among children and adolescents. It is estimated that 6,800 patients in the U.S. each year will develop progressive curvatures that do not respond to bracing.

A first of its kind device to treat pediatric patients with progressive idiopathic scoliosis has won the FDA nod. The device, called The Tether - Vertebral Body Tethering System, developed by Zimmer Biomet Holdings, Inc. (ZBH), is intended to be used in children and adolescents to correct idiopathic scoliosis that has not responded to external bracing.

Commenting on the approval, Capt. Raquel Peat, Ph.D., director of the Office of Orthopedic Devices in the FDA's Center for Devices and Radiological Health, said, "For children and adolescent patients with idiopathic scoliosis that does not respond favorably to bracing, treatment options have been limited to fusion surgeries. Today's approval provides access to a new treatment option that could improve quality of life for patients with idiopathic scoliosis."

Now, here's the list of drugs approved by the FDA in July 2019.

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