Multiple Myeloma Clinical Trial
Official title:
Evaluation of Vertebral Compression Fracture Fixation With RF Kyphoplasty in Patients With Multiple Myeloma
The objective of this post market clinical study is to collect prospective clinical data to confirm the efficacy of RF Kyphoplasty for the treatment of pathological fractures of the spine caused by multiple myeloma.
Myeloma is the commonest primary cancer affecting the spine. Painful vertebral compression
fractures (VCFs) affect approximately 30% of myeloma patients. As myeloma patients live
longer, it is especially relevant to provide the best available treatment for pain and
reduce disabilities that can result from VCFs.
Cement delivery is a well established treatment method for treating painful vertebrae
compromised by tumor and/or osteoporosis. The StabiliT Vertebral Augmentation System (DFine
Inc.) is a unique percutaneous vertebral augmentation system designed to provide the
physician a means of creating targeted cavities and an ultra-high viscosity cement (using RF
Energy) that can be delivered over an extended period of time in order to allow for
controlled, targeted vertebral augmentation in multiple myeloma patients.
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