Safe Orthopaedics has announced that the FDA has approved the marketing of the company’s new implant in the U.S. The product, known as the One-Step System, is meant for repairing traumatic spinal injuries and allows simultaneous fracture correction and spine stabilization.
As noted in the October 13, 2015 news release, “The innovative self-correcting screw mechanism offers gradual, automatic and reproducible vertebral fracture reduction with a surgical procedure similar to that of a standard thoracolumbar fusion, open or MIS [minimally invasive surgery]. Often caused by a trauma, vertebral fractures require swift surgical treatment. Designed for one-time use, the new One-Step System combines implants with single-use surgical instruments and is ready for use at all times, thus eliminating unnecessary delays.”
“The product was successfully launched in Europe in July 2015 shortly after the CE Mark was obtained. To date, more than 20 operations have been successfully performed in 5 Hospitals in France and the Netherlands. Additional Austrian and British Hospitals are about to initiate such operations.”
Asked about the development process, Dominique Petit, Founder, COO & CTO of Safe Orthopaedics, told OTW, “In order to restore the patient sagittal balance, spinal trauma procedure was performed using fixed pedicle screws, but they are very difficult to work with. To simplify the surgery, specifically during the rod insertion, the poly-axial screw is now more common but with a potential trade-off on spinal realignment. The One-Step System from Safe Orthopaedics combines all advantages of fixed and poly-axial pedicle screws. Surgery remains simplified but the implant provides automatic and controlled spinal correction.”
Asked about their plans for this product in the U.S., CEO Yves Vignancour commented to OTW, “Working with key spinal trauma surgeons we would like to establish the one-stem system as a first-line option for thoracolumbar trauma patients.”
