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Blazer Vertebral Augmentation System for Minimally Invasive Treatment of Spinal Compression Fractures 2012

Interventional Spine

H. Paul, Hatten, Jr., M.D.
Larry, E, Miller, Ph.D., Non ASSR Member
Jon, E, Block, Ph.D., Non ASSR Member

Paper/Non-Mentor

Purpose

To determine the safety and effectiveness of a vertebral augmentation device for treatment of spinal compression fracture that creates channels in the vertebral body to allow targeted polymethylmethacrylate bone cement flow.

Methods & Materials

Nine spinal compression fractures in 8 women (mean age: 81 years, mean collapse: 51%) were prospectively treated at a single center by the same neuroradiologist (HPH) with the Blazer Vertebral Augmentation System (Benvenue Medical, Inc., Santa Clara, CA). This system offers targeted circular channel creation via a unipedicular technique and controlled bone cement delivery. Main study outcomes were pain severity using a visual analogue scale, radiographically identified events including bone cement leak and adjacent or subsequent fracture, and clinical events including reoperation and revision at the index level. The follow-up period for all post-treatment assessments was 7 days.

Results

Clinical utility of the Blazer Vertebral Augmentation System was excellent. Curvilinear vertebral channels were created in each vertebra and targeted cement delivery through the bone channels was easily achieved. Mean back pain severity scores decreased from 7.2 at pre-treatment to 0.9 at follow-up. No clinical adverse events were reported.

Conclusion

The early experience with the Blazer Vertebral Augmentation System suggests that this device may have particular usefulness in the treatment of spinal compression fracture. The bone channels produced by the device allow targeted cement delivery from endplate to endplate, with potentially superior interdigitation compared to balloon assisted systems. Larger long-term studies are needed to corroborate the findings of this early clinical experience.

References/Financial Disclosures

Consultant Benvenue Medical, Inc.