FDA to Convene Dispute Resolution Panel for FzioMed

FzioMed recently received U.S. Food and Drug Administration (FDA) approval of its petition for an independent review of its premarket approval (PMA) application for Oxiplex gel.

Oxiplex is an absorbable, clear, viscoelastic gel that is applied during lumbar spine surgery.
FzioMed originally filed its Oxiplex PMA in 2007. The FDA responded with a not-approvable letter in 2008, citing insufficient evidence of the gel’s effectiveness to aid in healing.

In December 2012, the San Luis Obispo, Calif.-based company filed a citizen’s petition asking for a reconsideration of the application. Company officials said they have been working for 12 years to gain FDA approval to market this device in the U.S.

According to the company, 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 FDA will convene a dispute resolution panel (DRP). This panel provides advice 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 wants the DRP recommend a reversal of FDA’s earlier denial of its PMA for Oxiplex.

“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,” said John Krelle, president and CEO of FzioMed. “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 was studied in two FDA-approved investigational device exemption (IDE) clinical trials in the United States, as well as two foreign confirmatory clinical studies in subjects undergoing spine surgery. The IDE pivotal study, which required more than five years to complete, 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, according to the company.

Privately held FzioMed was founded in 1996. The company develops absorbable surgical biomaterials based on its patented polymer science. FzioMed adhesion barriers are used in spine, orthopedics, hand, tendon, peripheral nerve, gynecology and general surgery. Its spine gel is distributed by Medtronic, DePuy Synthes, as well as other independent distributors.