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FzioMed spine gel wins expedited review

This article was originally published in The Gray Sheet

Executive Summary

FzioMed's PMA for its Oxiplex spine surgery gel is accepted for expedited FDA review, the firm announces Oct. 4. The absorbable adhesion barrier is applied to the nerve root during lumbar disc surgery to reduce post-operative pain and other symptoms. According to FzioMed, FDA granted expedited review status because there are no alternative products approved in the United States. Oxiplex, cleared in Europe in 2001, is marketed outside the United States under the brands Oxiplex/SP and MediShield and has been used in more than 80,000 surgeries
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