VertiFlex Sends Final Piece of Superion PMA Application to the FDA

VertiFlex Inc., a developer of minimally invasive spinal surgery technologies, has submitted the final module of the pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) to support approval of the company’s Superion Interspinous Spacer System (ISS).

The final module for FDA covers the clinical results from the Superion investigational device exemption (IDE) trial evaluating the safety and effectiveness of the device for the treatment of lumbar spinal stenosis.

“This submission is the culmination of several years of dedicated research,” said Earl R. Fender, president and CEO of VertiFlex. “This is the largest and most rigorous FDA trial ever completed for spinal stenosis. I am very grateful for the dedication of our research team and look forward to working with the FDA to bring this promising technology to market, to help many of the more than 1 million U.S. patients diagnosed annually, with lumbar spinal stenosis.”

The Superion IDE trial involved enrollment of 470 patients between June, 2008 and December 2012 at 31 centers across the United States. Patients were randomized 1:1 to either the Superion ISS or the commercially available X-Stop IPD made by Medtronic Inc.

Superion is designed to achieve indirect spinal decompression for patients suffering from neurogenic intermittent claudication due to moderate lumbar spinal stenosis. Superion is implanted minimally invasively through a cannula designed to be less traumatic to the patient. The Superion ISS can be implanted under general or local anesthesia, according to the company.

Founded in 2005, San Clemente, Calif.-based VertiFlex is a privately held company that 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, according to company officials.