Medtronic has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance of Kyphon Xpede bone cement for fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. This expands the product’s indications beyond treatment of vertebral fractures due to osteoporosis, cancer or benign lesions.
“Sacral insufficiency fractures are associated with a tremendous amount of pain and debilitation for individuals who have them,” says Douglas Beall, chief of Radiology Services at Clinical Radiology of Oklahoma, Edmond, USA. “Having this new indication with Kyphon Xpede bone cement to use in the treatment of sacral fractures will help to address this patient population.”
A recent multi-centre retrospective study of 243 patients with osteoporotic sacral insufficiency fractures treated with sacroplasty reported significant pain relief for patients immediately following the procedure and after one-year follow-up; authors indicated that there were no major complications or procedure related deaths. The study reported a low procedure-related complication rate with 1 of 243 subjects (0.4%) having symptomatic leakage requiring decompression.