Safe Orthopaedics' Sycamore implant for spinal fractures was found to be "very satisfactory," according to three-month clinical data released by the company.
3 things to know:
1. An evaluation of Sycamore after three months saw pain reduction of about 65 percent according to the pain scales Owestry Disability Index and Visual Analog Scale, according to a Dec. 20 news release.
2. A previous study showed a 40 percent increase in compressive strength between a vertebra instrumented with the Sycamore device and a vertebra that had undergone only a simple balloon kyphoplasty.
3. Safe Orthopaedics expects to launch Sycamore outside the U.S. in January. The company expects FDA approval in the second half of 2022.