Auctus Surgical has received US Food and Drug Administration (FDA) breakthrough device designation for its vertebral body tethering (VBT) system, which the company says treats paediatric scoliosis with a “non-fusion, dynamic approach”.
This FDA designation allows for priority review and interactive communication regarding device development. In addition, the company has just received a US patent that covers the specific technologies and methods of the Auctus system.
According to Auctus, the system has been designed from the ground up in order to give adolescents a viable, flexible option to complex fusion surgery. Necessitating only one treatment event, the system utilises an external magnet controller for non-surgical adjustment of the spinal curvature over time.
John Barrett, CEO and founder of Auctus, said: “These back-to-back achievements continue the momentum in the development of this critical therapy. I am proud of the tremendous efforts put forth by our team—efforts that will make a concrete difference in the lives of suffering adolescents and their families.”
Mohammad Diab, professor and vice chair in the Department of Orthopaedic Surgery and the Department of Paediatrics at the University of California (San Francisco, USA), added: “Spinal fusion for scoliosis is a century old operation that corrects deformity but eliminates movement of the spine.
“The paediatric surgical community, as well as our patients, are eager for and welcoming of a fusionless option for the treatment of scoliosis. The Auctus Dynamic Tethering System will do just that and will do so in a modular manner that allows greater control of the spine.”