Amber Implants’ VCFix spine system for vertebral compression fractures showed clinical improvements in one-year follow-ups in its first human clinical trial.
No trial participants had device-related adverse events after a year, and there were “significant” improvements in key clinical performance outcomes, according to a June 3 news release.
By the six-month follow up, pain scores decreased by more than eight points, and disability scores showed an 84-point reduction from baseline. Those results were maintained through the one-year follow-up period.
Amber Implants is preparing clinical trials at multiple sites in Europe, including two centers in the first clinical study.
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