Safe Orthopaedics Granted CE Mark for Sycamore Osteoporotic Fracture Treatment

By Julie A. Vetalice

Safe Orthopaedics Granted CE Mark for Sycamore Osteoporotic Fracture Treatment

Safe Orthopaedics and Safe Medical announce approval under the CE Mark for Sycamore, a new treatment for patients with one or more osteoporotic fractures.

Sycamore is a minimally invasive, ready-to-use technology that improves the first treatment of one or more fractures and reduces the risk of recurrence in osteoporotic patients.

In lab testing, Safe Orthopaedics has demonstrated the potential clinical benefit of this technology on human vertebrae, increasing the strength of a cementoplasty-reconstructed vertebra by more than 30%, reducing the risk of post-operative vertebral collapse and re-operation.

Safe Orthopaedics is launching a multicenter study of Sycamore in France and Germany, and expects global product launch to occur in 2022. The system is delivered in a ready-to-use kit, including minimally invasive instrumentation and sterile implants.

“Motivated by the clinical challenges expressed by surgeons, our research team is committed to finding simple and effective solutions. We are proud to announce the launch of this new technology called Sycamore and to complete our range of SteriSpineVA products for the management of patients with vertebral fractures,” said Pierre Dumouchel, Chairman and CEO of Safe Group. "Sycamore is the first project resulting from the consolidation of our Safe Group, designed by Safe Orthopaedics and produced by Safe Medical and is part of our plan to accelerate innovation and double-digit commercial growth.”

Product Labels: Vertebroplasty/Kyphoplasty

Tags: CE Mark, Regulatory