FzioMed, a medical device manufacturer focusing on biomaterials, has received notification from U.S. Food and Drug Administration that the Medical Device Dispute Resolution Panel will convene and make a decision on the approval of Oxiplex Gel on June 10.
Oxiplex is an absorbable, clear, viscoelastic hydrogel, which is intended for use during lumbar spine surgery. It has been approved for sale in the European Union since 2002.
The Medical Device Dispute Resolution Panel will meet to decide whether to overturn Center for Devices and Radiological Health's initial denial of Oxiplex's premarket approval 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 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, demonstrates that Oxiplex can offer increased clinical benefit compared to discectomy surgery alone, while presenting no significant safety risk."
More Articles on Devices:
Mazor Robotics 2013 Net Loss Shoots to $20M
Advancement in Lateral Spine Technology: Q&A with Vertebral Technologies, Inc. CEO Dr. Jeffrey Felt
EDGE Orthopaedics Receives FDA 510(k) Clearance for BITE Compression Screws