10.14.15
Eragny-Sur-Oise, France-based Safe Orthopaedics, which makes sterile implants for use in combination with its single-use surgical instruments, today announces that the U.S. Food and Drug Administration (FDA) has approved a new implant for repairing traumatic spinal injuries in the United States.
The One-Step system allows simultaneous fracture correction while stabilizing the spine, reducing the need for additional instruments and simplifying the surgery. The device’s self-correcting screw mechanism offers gradual, automatic and reproducible vertebral fracture reduction with a surgical procedure similar to that of a standard thoraco-lumbar fusion, either open or minimally invasive.
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.
One-Step’s U.S. introduction follows success in Europe. The product was successfully launched in Europe in July 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.
One-Step’s FDA approval gives Safe Orthopaedics its first entry into the U.S. spinal trauma market. Every year in the United States, more than 35,000 patients will receive spinal surgery for repairing traumatic thoraco-lumbar injuries.
The device will officially be launched at the North American Spine Society (NASS) annual meeting, which is being held Oct. 14 to 17 in Chicago, Ill.
Editor’s note: Safe Orthopaedics will participate in the NASS exhibition at booth 1295.
The One-Step system allows simultaneous fracture correction while stabilizing the spine, reducing the need for additional instruments and simplifying the surgery. The device’s self-correcting screw mechanism offers gradual, automatic and reproducible vertebral fracture reduction with a surgical procedure similar to that of a standard thoraco-lumbar fusion, either open or minimally invasive.
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.
One-Step’s U.S. introduction follows success in Europe. The product was successfully launched in Europe in July 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.
One-Step’s FDA approval gives Safe Orthopaedics its first entry into the U.S. spinal trauma market. Every year in the United States, more than 35,000 patients will receive spinal surgery for repairing traumatic thoraco-lumbar injuries.
The device will officially be launched at the North American Spine Society (NASS) annual meeting, which is being held Oct. 14 to 17 in Chicago, Ill.
Editor’s note: Safe Orthopaedics will participate in the NASS exhibition at booth 1295.