FzioMed, a medical device company, has received approval from the commissioner of the US Food and Drug Administration (FDA) of its petition for an independent review of its premarket approval application (PMA) for Oxiplex Gel.
Oxiplex is an absorbable, clear, viscoelastic gel that is applied during lumbar spine surgery. Oxiplex has been approved for sale in the European Union since 2001 and is now approved in 70 countries.
It has been used in more than 340,000 surgeries worldwide. The company has been working for 12 years to gain FDA approval to market this device in the US.
This action by the FDA calls for a special Medical Devices Dispute Resolution Panel (DRP) to be convened.
This panel provides advice to the Commissioner on complex or contested scientific issues between the FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, regulatory decisions and actions by the FDA, and Agency guidance and policies.
The panel makes recommendations on issues that are lacking resolution, are highly complex in nature, or result from challenges to agency decisions or actions.
In this case, FzioMed is seeking to have the DRP recommend a reversal of FDA’s earlier denial of its PMA for Oxiplex.
FzioMed president and CEO John Krelle noted the company commends the FDA for granting its petition for reconsideration, a rarely used part of the regulatory process that companies can pursue when their device application is denied by the FDA.
"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 US, demonstrate that Oxiplex can offer increased effectiveness compared to spine surgery alone, while presenting no significant safety risk," Krelle added.
No jurisdiction other than the US has ever denied an application for approval of Oxiplex, which has been available outside the US for more than a decade.
It is approved in 70 countries including the 28 member states of the EU, The Russian Federation, Canada, and Mexico, as well as on the continents of Africa, Australia, South America and Asia.
Oxiplex was studied in two FDA-approved investigational device wxemption (IDE) clinical trials, as well as two foreign confirmatory clinical studies in subjects undergoing spine surgery.
The IDE pivotal study, which required more than five years completing, found that subjects having both leg pain and severe preoperative back pain experienced a greater reduction in leg pain when treated with Oxiplex compared to undergoing surgery alone.
The extensive body of peer-reviewed published literature on Oxiplex, as well as extensive commercial experience outside the United States in more than 340,000 surgeries, provides additional evidence of the safety and effectiveness of the device for use in conjunction with spine surgery.