Safe Orthopaedics Launches New Pedicle Screw System

Officials with Ergany-Sur-Oise, France-based Safe Orthopaedics, a company developing sterile implants combined with their single-use surgical instruments, have reported the first use of the company’s new Auto-Adjust pedicle screw in surgical procedures to repair thoracic and lumbar spine fractures.

Auto-Adjust is a patented pedicle screw that gives Safe Orthopaedics access to the spinal trauma market, which the company estimates is worth nearly $900 million worldwide. The implant is designed to simplify surgical repair of vertebral fractures and facilitate the restoration of sagittal balance.

“The abilities of our new Auto-Adjust implant are very promising: not only does it make surgery safer, it also optimizes it and thus delivers greater benefits to the patient,” said Yves Vignancour, CEO of Safe Orthopaedics. “With Auto-Adjust, Safe Orthopaedics is continuing to innovate by providing unequalled and patented solutions to help spine surgeons. After Europe, we expect to make Auto-Adjust available in the United States before the end of the year.”

Auto-Adjust is a multi-axial screw that helps position the rods but operates like a fixed-head screw to realign the spine. This system provides gradual and automatic fracture reduction, with a surgical procedure identical to that of standard spinal fusion.

Mainly caused by a trauma, spinal fractures require swift surgical treatment. The new Auto-Adjust pedicle screw, combined with its single-use sterile instruments, is ready for use at all times and thus eliminates unnecessary delays.

To date, eight surgeries have been performed in France and the Netherlands, two of them through a percutaneous approach.

Hervé Vouaillat, M.D., orthopedic surgeon at Echirolles Clinique des Cèdres in France, said: “For the first time, we have been using a new type of pedicle screw in trauma that allows an easy reduction of the vertebral fracture through a percutaneous approach. This implant from Safe Orthopaedics provides reproducibility and therefore secures fracture reduction. Furthermore, the single-use instruments guarantee permanent availability.”

Jasper Wolfs, M.D., a neurosurgeon at Leidschendam Medical Center  in the Netherlands, added: “The Auto-Adjust Screw has the advantages of a polyaxial and a monoaxial screw. In traumatic spine injury in particular, this screw has the amazing ability to realign the spine and restore the sagittal balance. Many spine surgeons had been waiting for just such an implant.”

Safe Orthopaedics was founded in 2010. The company’s CE-marked and U.S. Food and Drug Administration-approved SteriSpinekits are marketed in 12 countries—in Europe and in the United States. Nearly 1,000 procedures were performed in 2014 and 550 in the first quarter of 2015, according to the company. The firm has 33 employees and a U.S. subsidiary.