The US FDA has given the approval to first spinal tether device to be used in adolescents and children having idiopathic scoliosis. It is an alternative to surgical treatment.
The Zimmer Biomet Spine wins grant of USFDA for Tether-Vertebral Body Tethering System.
The Tether-Vertebral Body tethering system imparts an alternate treatment for individuals having idiopathic scoliosis and who are not responding to bracing. The system is developed in a way, where curvature can be corrected with growth of patient. The complete motion range is also maintained through system in comparison to spinal fusion procedures.
The clinical data related with safety of Tether-Vertebral Body Tethering System was reviewed by the USFDA using humanitarian device exemption process. It contained the information about the 57 patients who had received the device.
General complications observed includes respiratory problems, bleeding, nerve injuries and pain which are consistent with any spinal surgical process. Tether breakage, air leakage into space between chest wall and lung and overcorrection of curvature were the severe adverse events observed.
Copyright © 2019 Institute of Good Manufacturing Practices India ( IGMPI® All Rights Reserved. Trademarks are the property of the owner )