FzioMed said the FDA granted an independent review of its pre-market approval application for the Oxiplex spinal surgery gel.
San Luis Obispo, Calif.-based FzioMed originally filed its PMA application for Oxiplex in October 2007. The FDA responded with a "not approvable letter" back in July 2008 after determining that FzioMed hadn’t provided sufficient evidence of the gel’s effectiveness in aiding in healing following lower back spinal surgery.
Last December the medical device company filed a citizen’s petition asking for a reconsideration of the PMA application.
The independent review nod from the FDA means that a Medical Devices Dispute Resolution Panel is slated to be convened to advise FDA commissioner Dr. Margaret Hamburg on whether to reverse the watchdog agency’s rejection of the Oxiplex PMA, FzioMed said.
"We commend the FDA for granting our petition for reconsideration, a rarely used part of the regulatory process that companies can pursue when their device application is denied by the FDA," FzioMed president & CEO John Krelle said in prepared remarks. "The totality of data from the various studies submitted to FDA on Oxiplex, representing approximately 500 patients studied over nearly a decade, combined with extensive clinical success achieved outside the U.S., demonstrate that Oxiplex can offer increased effectiveness compared to spine surgery alone, while presenting no significant safety risk."
Oxiplex has on the market in the European Union since 2001 and is approved in 70 countries, according to FzioMed.
"No jurisdiction other than the U.S. has ever denied an application for approval of Oxiplex, which has been available outside the United States for more than a decade. It is approved in 70 countries including the 28 member states of the European Union, The Russian Federation, Canada, and Mexico, as well as on the Continents of Africa, Australia, South America and Asia," according to the release.
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