Spine-Surgery Gel Fast-Tracked by FDA

FDA has granted expedited review status to a new gel for reducing pain and symptoms following lumbar spine surgery. The product, called Oxiplex and made by San Luis Obispo, CA-based FzioMed, currently faces no approved alternatives in the U.S.

News of fast-track status for Oxiplex came today, following FDA’s acceptance of the FzioMed’s pre-market approval (PMA) application.

Acceptance of the Oxiplex PMA brings us closer to offering U.S. surgeons a new tool, with the potential to improve clinical outcomes for countless patients, said John Krelle, president and CEO of FzioMed, in a statement. “Over a million people in the U.S. undergo spine surgery each year and lower back pain is a leading cause of disability.

Oxiplex is an absorbable gel used during lumbar laminectomy, laminotomy and discectomy surgical procedures. It is applied around the sensitive spinal nerve root and surrounding neural tissues, creating a protective environment during post-surgical healing; it does not interfere with normal healing and clears naturally from the body.

The PMA was based on final data from a multi-center, randomized, blinded, controlled U.S. pivotal study. Outside the U.S., Oxiplex is approved for sale in 47 countries and has been used in more than 80,000 surgeries.

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