Two-Year Trial Results Released for VertiFlex’s Spinal Stenosis System

VertiFlex Inc., a developer minimally invasive interventions for spinal stenosis (inflammation of the nerves emanating from the spinal cord), has released two-year clinical results of the Superion indirect decompression system.

Spinal stenosis is a leading cause of spinal surgery in the elderly.

Vikas Patel, M.D., from the University of Colorado, and colleagues, reported outcomes from the first 250 patients enrolled in a prospective, multi-center, randomized U.S. Food and Drug Administration (FDA) investigational device exemption clinical trial comparing results of the minimally invasive Superion system to an alternative surgical control device—the X-Stop made by Medtronic Inc.

A peer-reviewed research paper is published in BMC Musculoskeletal Disorders and can be found here.

“This publication is the first to detail the long-term results from our Superion IDE trial,” said Earl R. Fender, president and CEOof San Clamente, Calif.-based VertiFlex. “I’m pleased that these outcomes are positive and consistent with our previously published international experience.”

According to the study, leg pain scores in this group of patients improved more than 75 percent from baseline at two years. These results compared 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. two to three days with more invasive surgeries, and return quickly to normal activities, the company reported.

“This represents a very meaningful change in care for patients suffering from spinal stenosis,” Fender said. “Our full data set of 470 patients is now complete and currently under PMA (premarket approval application) 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 (pain or weakness in the leg caused by a problem at the nerve) 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.

VertiFlex is privately held medical device company founded in 2005. The company’s technology for performing indirect and direct decompressions of the lumbar spine are designed to 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.