FDA Approval & #039;Finally & #039; Recognizes Vertebral Body Tethering as a Mainstream Scoliosis Treatment

A first-of-its-kind FDA approval represents a major win for Zimmer Biomet and, most importantly, the field of scoliosis treatment. Called The Tether – Vertebral Body Tethering System, the device is intended to treat growing children and adolescents whose spinal curves are approaching or have reached the range where surgical treatment is an option. It is intended to correct the most common form of scoliosis (idiopathic scoliosis) that has not responded to conservative treatment options, such as external bracing. “This decision takes an innovative surgical approach, vertebral body tethering, and finally recognizes it as a mainstream option for scoliosis treatment,” said Baron Lonner, MD, chief of minimally invasive scoliosis surgery at The Mount Sinai Health System. “This FDA approval sets the stage for better patient outcomes for thousands of children who undergo surgery for scoliosis around the country every year.” Lonner, a world-leading scoliosis specialist, is among the few surgeons performing vertebral body tethering (VBT) in the United States prior to this approval. He has performed VBT more than 220 times. Prior to this approval, these specialists were repurposing an implant that was initially approved for use in adult lumbar procedures, slightly modifying the implant for use in the pediatric population. The benefits of VBT led to growing demand ...
Source: MDDI - Category: Medical Devices Authors: Tags: Orthopedics Implants Source Type: news