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FzioMed and FDA schedule Medical Device Dispute Resolution Panel meeting

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FzioMed Inc. announced the FDA Medical Device Dispute Resolution Panel will convene on June 10 to make a decision about approvability of the company’s Oxiplex Gel product, which is an anti-adhesion gel applied during lumbar spine surgery.

The FDA Medical Device Dispute Resolution Panel provides advice to the Commissioner of the FDA on complex or contested scientific issues between the FDA and medical device sponsors, applicants or manufacturers related to specific products, marketing applications, significant regulatory decisions and actions by the FDA, and agency guidance and policies. According to a company press release, the panel will decide whether to overturn the denial from the Center for Devices and Radiological Health (CDRH) of the Oxiplex Premarket Approval application or uphold the previous decision.

“For more than a decade, FzioMed has been seeking approval of Oxiplex in the United States,” John Krelle, president and CEO of FzioMed, stated in the release. “Over the course of its review, the FDA’s CDRH has reviewed data on approximately 500 patients from four peer-reviewed published studies spanning three continents. The totality of data from the various studies submitted to FDA on Oxiplex, combined with extensive clinical success achieved around the world, demonstrate that Oxiplex can offer increased clinical benefit compared to discectomy surgery alone, while presenting no significant safety risk.”

FzioMed officials noted in the release Oxiplex has been approved for sale in the European Union since 2002. In all, it is approved in 70 countries and has been used in more than 350,000 surgeries worldwide.