Minimally invasive spine technologies company, VertiFlex®, Inc., has announced submission of the final module of the pre-market approval (PMA) application to the U.S. FDA to support approval for its Superion® Interspinous Spacer System.
The Superion Interspinous Spacer (ISS) is a motion-preserving, indirect decompression spinal implant system for the treatment of moderate lumbar spinal stenosis. The device 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 and can be implanted under general or local anesthesia.
The final module of Vertiflex’s Superion submission covers the clinical results from the Superion IDE trial evaluating the safety and effectiveness of the Superion Interspinous Spacer (Superion ISS) for the treatment of 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®.
“This submission is the culmination of several years of dedicated research,” commented Earl R. Fender, President and Chief Executive Officer of VertiFlex, Inc. “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.”
Source: VertiFlex, Inc.