FDA Reschedules Advisory Panel Meeting on VertiFlex PMA Application

The U.S.Food and Drug Administration (FDA) has rescheduled an advisory panel meeting to consider VertiFlex Inc.’s pre-market approval (PMA) application for its Superion Interspinous Spacer System.

The agency’s Orthopedic and Rehabilitation Devices Advisory Panel now will consider the company’s application on Feb. 20. The panel was supposed to discuss and vote on VertiFlex’s PMA onDec. 12; FDA officials rescheduled the vote because they could not complete an 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/CEO of VertiFlex. “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. 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, according to VertiFlex. 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 more than 2,000 patients worldwide. Superion currently is an investigational device in the United States. The Superion IDE trial involved the 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.

Founded in 2005 and headquartered in San Clemente, Calif., privately held 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 claims it has compiled the largest, most rigorous body of device clinical evidence related to lumbar spinal stenosis.