VertiFlex announces submission of the final module of the pre-market approval (PMA) application to the US Food and Drug Administration (FDA) to support approval for the Superion interspinous spacer system. The final module covers the clinical results from the Superion investigational device exemption trial evaluating the safety and effectiveness of the Superion interspinous spacer system for the treatment of lumbar spinal stenosis.
“This submission is the culmination of several years of dedicated research,” comments Earl R Fender, president and chief executive officer 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 one million US patients diagnosed annually, with lumbar spinal stenosis.”
The Superion investigative device exemption trial involved enrolment of 470 patients between June, 2008 and December 2012 at 31 centres across the United States. Patients were randomised 1:1 to either the Superion interspinous spacer system or the commercially available X-STOP IPD. 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 interspinous spacer system can be implanted under general or local anaesthesia.