FzioMed Awaits FDA Panel Meeting on Oxiplex/SP Gel Approval
BY HAL BRIGHAM, JUNE 17, 2008
Having already received market approval in 49 countries, FzioMed now has its sights set on U.S. clearance for its Oxiplex/SP Gel, an adhesion barrier used in lumbar spinal surgery. The FDA announced last week that the Oxiplex technology will be addressed at a July 15th meeting of the Orthopedic and Rehabilitation Devices panel, an important step in gaining market approval. The panel will discuss, make recommendations and vote on Oxiplex's PMA application, and that decision will guide the FDA in making its final ruling on the product.
FzioMed’s Oxiplex/SP Gel aims to reduce pain and neurological symptoms following lumbar spinal surgery. The company adds that the Oxiplex technology can also be used for pain control, as the gel can double as a method for drug delivery. Worldwide, Oxiplex has been applied in more than 90,000 spinal surgeries, including U.S. clinical trials cases.
July 16 update: See our firsthand reporting and analysis of the FDA Oxiplex panel decision.
