Zimmer Biomet (NYSE:ZBH) said it received the first FDA approval for a spinal tether device intended to correct pediatric scoliosis.
Warsaw, Ind.-based Zimmer Biomet’s tether is an anterior vertebral body tethering solution that uses a flexible cord as an alternative to metal rods. The cord is designed to pull on the outside of a scoliosis curve to straighten the spine while allowing the inside of the curve to grow.
“Often growth in children with scoliosis results in curve progression,” Dr. Amer Samdani, of the Philadelphia Shriners Hospitals for Children, said in prepared remarks. “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.”
“The Tether embodies Zimmer Biomet’s mission to improve the quality of life for people around the world,” added president Jim Cloar. “This collaboration demonstrates how a focused, shared purpose can fundamentally change the way we approach treatment of diseases like scoliosis. Working together, clinicians, the FDA and Zimmer Biomet have given surgeons an important fusion-less scoliosis treatment option for their pediatric patients. This procedure gives kids the best option for maintaining spine mobility and reaching their full potential.”
The FDA granted a humanitarian device exemption for the tether. Zimmer Biomet said it’s discussing a new clinical trial to monitor outcomes with the federal safety watchdog and the Harms Study Group.