US-based VertiFlex has submitted 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 (ISS).
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.
The Superion IDE trial enrolled 470 patients between June, 2008 and December 2012 at 31 centers across the US. Patients were randomized 1:1 to either the Superion ISS or the commercially available X-STOP IPD.
The final module covers the clinical results from the Superion IDE trial evaluating the safety and effectiveness of the Superion ISS for the treatment of lumbar spinal stenosis.
VertiFlex president and CEO Earl Fender said the submission is the culmination of several years of dedicated research.
"This is the largest and most rigorous FDA trial ever completed for spinal stenosis," Fender added.
"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."