VertiFlex®, Inc. Announces Publication of Superion® IDE Trial Results
SAN CLEMENTE, Calif.--(BUSINESS WIRE)--VertiFlex®, Inc., a leading innovator of advanced minimally invasive interventions for spinal stenosis, announces publication of two-year clinical results of the Superion® Indirect Decompression System. Dr. Vikas Patel, from the University of Colorado, and colleagues, reported outcomes from the first 250 patients enrolled in a prospective, multi-center, randomized FDA IDE trial comparing results of the minimally invasive Superion Indirect Decompression System to an alternative surgical control device. This peer-reviewed research paper is published in BMC Musculoskeletal Disorders and can be found at the flowing link http://www.biomedcentral.com/1471-2474/15/221/abstract.
“This publication is the first to detail the long-term results from our Superion IDE trial”
“This publication is the first to detail the long-term results from our Superion IDE trial,” commented Earl R. Fender, President and Chief Executive Officer of VertiFlex, Inc. “I’m pleased that these outcomes are positive and consistent with our previously published international experience. Leg pain scores in this group of patients improved more than 75% from baseline at two years. These results compare favorably with surgical laminectomy, long considered the gold standard for spinal decompression. Further, because the Superion procedure does not involve destabilizing muscle resection and bone removal, as is the case with laminectomy, patients are generally able to leave the treatment facility in a few hours, vs. 2-3 days with more invasive surgeries, and return quickly to normal activities. This represents a very meaningful change in care for patients suffering from spinal stenosis. Our full data set of 470 patients is now complete and currently under PMA review by the FDA.”
The Superion IDE trial involved 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®. 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 about the size of a dime and typically performed under local anesthesia.
About VertiFlex, Inc.
VertiFlex is a privately held medical device company dedicated to the advancement of minimally invasive solutions for the treatment of lumbar spinal stenosis, which is the leading cause of spinal surgery in the elderly. Founded in 2005 and headquartered in San Clemente, CA, 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 has compiled the largest, most rigorous, body of device clinical evidence, related to lumbar spinal stenosis.