Safe Orthopaedics shares 3-month clinical data for spinal fracture implant

Safe Orthopaedics’ Sycamore implant for spinal fractures was found to be “very satisfactory,” according to three-month clinical data released by the company.

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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.

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