Safe Orthopedics Announces First 3-Month Clinical Benefits and Global Launch of Sycamore
► Result of the 3-month follow-up
► 65% pain reduction (ODI & VAS scales)
► Global launch in early January 2022
► Approval in the United States expected in 2022
Éragny-sur-Oise, Fleurieux-sur-l’Arbresle, December 20, 2021 at 5:35 p.m. CET – Safe (FR0013467123 – ALSAF), a company specializing in the design, manufacture and marketing of ready-to-use technologies for back surgery, which is particularly safe for vertebral fractures treated urgently, announces the end of the first evaluation of Sycamore at 3 months of the first cases of surgery by the group of evaluating surgeons.
On May 24, 2021, Safe Orthopedics announced the CE marking of Sycamore, Implant intended to secure the treatment of vertebral fractures and reduce the risk of adjacent fractures.
In a previous biomechanical study, on human vertebrae, it had also been demonstrated that the compressive strength was increased by 40% between a vertebra instrumented with the Sycamore device and a vertebra that had only undergone a simple balloon kyphoplasty. .
On December 18, 2021, the meeting of the Franco-German surgeons evaluators of Sycamore was held in order to decide on the evaluation of the clinical benefits at 3 months and in particular the evaluation of the pain reduction over several dozen surgeries.