SAN CLEMENTE, Calif.--(BUSINESS WIRE)--VertiFlex®, Inc., a leading innovator of advanced minimally invasive interventions for spinal stenosis, announced the first patients have been treated in the STEPS Trial by Dr. Bradly S. Goodman in Birmingham, Alabama.
The STEPS Trial (Study To Evaluate PILD for Stenosis) is a prospective, multi-center, randomized, double-blind trial evaluating the VertiFlex® Totalis™ Direct Decompression System versus a simulated surgical procedure in patients with lumbar spinal stenosis. The national trial is being conducted at up to 20 leading interventional spine sites throughout the US and is expected to enroll approximately 168 patients.
The principal purpose of the STEPS Trial is to provide Level 1 evidence that Percutaneous Image-Guided Lumbar Decompression (PILD) meaningfully improves health outcomes and is “reasonable and necessary” as defined by the Centers for Medicare & Medicaid Services (CMS). The study is being conducted in collaboration with CMS under the Agency’s Coverage with Evidence Development (CED) guidance and is intended to pave the way to broad reimbursement coverage for the procedure by Medicare.
“This is an important milestone for VertiFlex as we are committed to advancing differentiated spinal interventions through vigorous clinical research,” said Earl R. Fender, President and Chief Executive Officer of VertiFlex, Inc. “We have worked closely with CMS over the past several months to develop a very robust study protocol, and are pleased to pursue this evidence-based pathway to reimbursement for our unique Totalis procedure for Medicare beneficiaries.”
According to Dr. Goodman, "Many of my lumbar spinal stenosis patients could benefit from a minimally invasive outpatient treatment option that avoids traditional spinal decompression surgery. I am very excited about the promise of the Totalis procedure and am proud to participate as a Principal Investigator in this groundbreaking clinical trial. This trial is designed to develop the highest level of scientific evidence to date for this procedure category.”
The Totalis Direct Decompression System is a unique set of surgical instruments designed to perform minimally invasive decompression of the lumbar spine. The procedure is performed through the VertiFlex proprietary interspinous access platform utilizing a small working cannula about the size of a dime. It provides physicians the ability to remove targeted ligament, bone, and facet capsule material. This broad decompression involves minimal collateral tissue disruption and can be performed under local anesthesia. The Totalis System was 510(k) cleared by the FDA and has been commercially available in the US since March 2013.
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.