One-year Follow-up for Amber Implants VCFix Spinal System

Amber Implants completed one-year follow-up for all patients enrolled in its first-in-human clinical trial of the VCFix Spinal System for the treatment of vertebral compression fractures.

No device-related adverse events were reported in any patient at the one-year follow-up. Significant improvements in key clinical performance outcomes were observed, regardless of cement augmentation. Patients, both with and without cement, experienced immediate and sustained reductions in pain levels, as assessed by the Numeric Pain Rating Scale. By six-month follow-up, pain scores decreased by more than eight points. Disability scores, assessed using the Oswestry Disability Index, also showed significant post-operative improvement, with an 84 point reduction from baseline to six months. These improvements were generally maintained throughout the one-year follow-up period, indicating lasting functional benefits.

Amber Implants is now preparing to initiate its pivotal clinical trial across multiple sites in European countries, including the two centers that participated in this study. The upcoming study will evaluate the safety and efficacy of VCFix in its stand-alone configuration in a larger number of patients.

The VCFix Spinal System is designed to restore fractured vertebra and stabilize affected spinal segments. Its design supports the treatment of a wide range of vertebral fracture types both with and without cement, and with or without posterior fixation. Its versatility makes it suitable for indications ranging from osteoporotic low-energy fractures to traumatic high-energy fractures.

VCFix has received Breakthrough Device Designation from FDA.

Source: Amber Implants