SAN CLEMENTE, Calif.--(BUSINESS WIRE)--VertiFlex®, Inc., a leading innovator of advanced minimally invasive interventions for spinal stenosis, announced today the U.S. Food and Drug Administration (FDA) has scheduled an Orthopedic and Rehabilitation Devices Advisory Panel meeting on February 20, 2015 to discuss, make recommendations, and vote on the company’s Premarket Approval (PMA) Application for the Superion® Interspinous Spacer System. The meeting, which was originally scheduled for December 12, 2014, has been re-scheduled by the FDA because they were unable to complete their internal review of the PMA data in time for the December meeting.
“We are excited to be in the final stages of our Superion PMA application and look forward to the February 20 Panel date,” said Earl R. Fender, President and Chief Executive Officer of VertiFlex, Inc. “While disappointed in the postponement of the December Panel, the Agency has advised VertiFlex that it remains committed to meeting its MDUFA final decision timeline goal, and will continue collaborative efforts with the company to resolve all issues leading to the final decision. That position is but one example of the positive working relationship we’ve had with the FDA throughout this PMA process. While we believe we were fully prepared for Panel on December 12, we will use the additional time for further analysis and preparation, and we continue to anticipate a positive outcome with the trial.”
The Superion Interspinous Spacer System is a minimally invasive spinal implant designed to treat moderate lumbar spinal stenosis. Superion is delivered through a cannula about the size of a dime and typically performed under local anesthesia. Once in place, it may reduce pressure on the affected nerves and allow patients to return to a more active lifestyle. Superion has been CE marked since 2007 and implanted in over 2000 patients worldwide. Superion is currently an investigational device in the United States. The Superion IDE trial involved enrollment of 470 patients at 31 centers across the United States. Patients were randomized 1:1 to either the Superion System or the commercially available X-STOP® IPD®. The final PMA application was submitted to the FDA in March, 2014.
About VertiFlex, Inc.
VertiFlex is a privately held medical device company dedicated to the advancement of minimally invasive solutions for the treatment of lumbar spinal stenosis, which is the leading cause of spinal surgery in the elderly. Founded in 2005 and headquartered in San Clemente, CA, VertiFlex has developed proprietary, minimally invasive technologies for performing both indirect and direct decompressions of the lumbar spine. These procedures fill the gap in the stenosis treatment continuum between conservative care and traditional spine surgery, providing new options for interventional spine physicians and less invasive options for traditional spine surgeons. To date, VertiFlex has compiled the largest, most rigorous body of device clinical evidence related to lumbar spinal stenosis.