SAN LUIS OBISPO, Calif.--(BUSINESS WIRE)--FzioMed, a medical device company that recently celebrated the 17th anniversary of its founding, has received approval from the Commissioner of the U.S. Food and Drug Administration 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 U.S.
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.
“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 Has Been Used in Hundreds of Thousands of Surgeries Outside the U.S.
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.
- Oxiplex was studied in two U.S. FDA-approved Investigational Device Exemption (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 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.
- 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.
About FzioMed
FzioMed is a privately held medical device company founded in 1996. The Company develops, manufactures and commercializes absorbable surgical biomaterials based on its patented polymer science. FzioMed adhesion barriers are used in many surgical applications including spine, orthopedics, hand, tendon, peripheral nerve, gynecology and general surgery. Its spine gel is the number one barrier gel for spine surgery worldwide and is distributed by Medtronic, DePuy (a division of Johnson & Johnson) and other independent distributors. For more information please visit www.fziomed.com
FzioMed® and Oxiplex® are registered trademarks of FzioMed, Inc. MediShield™ is a trademark of Medtronic Sofamor Danek USA, Inc.
