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FzioMed’s spine surgery gel wins approval in Canada

Medical device firm FzioMed has said that the Health Canada has approved the company's Oxiplex gel for use in lumbar spine surgery.

Health Canada’s approval of Oxiplex for spine surgery was based on final data from a US multi-center, randomized, blinded, controlled study involving 352 patients.

Oxiplex is an absorbable gel that is applied to spinal nerve roots during lumbar laminectomy, laminotomy and discectomy procedures. Oxiplex creates a temporary, protective barrier against the damaging effects of excessive fibrosis, inflammation and other irritants that can lead to recurrent postoperative pain. Oxiplex has been shown to improve spine surgery outcomes by significantly reducing postoperative leg pain, back pain and neurological symptoms.