The Sycamore system has been adopted quickly by my operating room team with the learning curve being substantially shorter than expected.
FREMONT CA: Safe Orthopedics (FR0013467123 – ALSAF), a company specializing in the design, manufacturing, and marketing of single-use technologies for spinal surgeries that deliver the safest treatment for urgently treated spinal fractures, announces the completion of the first three month evaluation of the first surgical cases. Safe Orthopedics proclaimed the CE marking on May 24, 2021 that Sycamore, an implant designed to secure the treatment of vertebral fractures while reducing the risk of adjoining fractures.
Biomechanical study on human vertebrae said that a vertebra instrumented with the Sycamore device had a 40 percent increase in compressive strength which had undergone a simple balloon Kyphoplasty. The French-German surgeon evaluators of Sycamore decided to evaluate the clinical benefits at 3 months and also evaluate the reduction of pain on several dozen surgeries on December 18, 2021. The Owestry Disability Index (ODI) and Visual Analog Scale (VAS) pain scale gave very satisfactory results with a reduction of pain of around 65% in post-surgery.
According to Pr Jean-Charles Le Huec, Orthopedic surgeon and traumatologist at the Polyclinic of Bordeaux Nord Aquitaine, the treatment available for VCF fractures, distinctly in brittle bone, to be sub-optimal. The study shows that re-compression with kyphoplasty is usual and can lose sagittal balance. To reduce the chance of re-compression and subsequent adjacent fractures, Sycamore implant is designed by anchoring the implant, and thus the fracture correction, in the strongest attachment point of the spine, the pedicle. With these early results, Sycamore’s Safe Orthopedics team has developed a safe and effective product.
Pierre Dumouchel, Safe Group’s Chairman and CEO noted that Sycamore’s safety and pain reduction clinical outcomes are in line with their calculations. In early January 2022 Sycamore will be launched globally with the exception of the US, and approval for Food and Drugs Administration for Sycamore will be expected in the second half of the year.