SAN LUIS OBISPO, Calif.–(BUSINESS WIRE)–FzioMed, Inc., a medical device manufacturer specializing in biomaterials, has received notification from FDA that the Medical Device Dispute Resolution Panel (MDDRP) will convene and make a decision on the approvability of Oxiplex Gel on June 10, 2014.
Oxiplex is an absorbable, clear, viscoelastic hydrogel that is applied during lumbar spine surgery. Oxiplex has been approved for sale in the European Union since 2002 and is now approved in 70 countries. It has been used in more than 350,000 surgeries worldwide. The Company has been working for 12 years to gain FDA approval to market this device in the U.S.
The MDDRP provides advice to the Commissioner of the U.S. Food and Drug Administration (FDA) on complex or contested scientific issues between the FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, significant regulatory decisions and actions by the FDA, and Agency guidance and policies. The Panel is convened infrequently and makes recommendations on issues that are lacking resolution, in this case they will decide whether to overturn CDRH’s denial of the Oxiplex PMA or uphold the previous decision.
”For more than a decade, FzioMed has been seeking approval of Oxiplex in the U.S.,” said John Krelle, President and CEO of FzioMed. “Over the course of its review, the FDA’s Center for Devices and Radiological Health (CDRH) has reviewed data on approximately 500 patients from four peer-reviewed published clinical 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.”
Oxiplex Has Benefitted Hundreds of Thousands of Patients Around the World.
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 investigated in two U.S studies under an FDA-approved Investigational Device Exemption (IDE), as well as studies in Italy and China, that confirm the results of the U.S. study in subjects undergoing discectomy surgery. The IDE pivotal study, which required more than five years to complete, found that subjects having both predominant leg pain and severe preoperative back pain, experienced a greater reduction in leg and back pain when treated with Oxiplex compared to undergoing surgery alone. In addition, patients receiving Oxiplex had fewer reoperations and more patients achieving zero pain scores at study end compared to those receiving discectomy surgery only. This group of patients has been identified in the literature (including the widely referenced SPORT study [1]) as one that often does not experience the magnitude of benefit in reduction of leg pain that is generally experienced following discectomy surgery. Other studies including those from Kleinstueck et al [2] and el Barzouhi et al [3], also found higher levels of back pain to be a predictor of a poorer outcome after such surgery resulting in large groups of patients with unsatisfactory outcomes. This is the target group that benefits the most from the adjunctive effect of Oxiplex.
- The extensive body of peer-reviewed published literature on Oxiplex, as well as extensive commercial experience outside the United States in more than 350,000 surgeries, provides additional evidence of the safety and effectiveness of the device for use in conjunction with discectomy 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.
References
1. Weinstein JN, Lurie JD, Tosteson TD, Skinner JS, Hanscom B, Tosteson AN, Herkowitz H, Fischgrund J, Cammisa FP, Albert T, Deyo RA (2006) Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT) observational cohort. JAMA 296:2451–2459
2. Kleinstueck, F.S., Fekete, T, Jeszenszky D, Mannion AF, Grob D, Lattig F, Mutter U, Porchet F (2011) The outcome of decompression surgery for lumbar herniated disc is influenced by the level of concomitant preoperative low back pain. European Spine Journal online: 12 January 2011
3. el Barzouhi A, Vleggeert-Lankamp CLAM, Lycklama a Nijeholt GJ, Van der Kallen BF, van den Hout WB, Koes BW, Peul WC, for the Leiden-The Hague Spine Intervention Prognostic Study Group. (2014) Influence of Low Back Pain and Prognostic Value of MRI in Sciatica Patients in Relation to Back Pain. PloS ONE 9(3)
Contacts
FzioMed, Inc.
John Krelle, President & CEO
805.546.0610
