VertiFlex announces first study patients treated in approved coverage with evidence development trial


VertiFlex announced the first patients have been treated in the STEPS trial by Bradly S Goodman in Birmingham, Alabama, USA.

The STEPS Trial (Study to evaluate PILD for stenosis) is a prospective, multicentre, randomised, 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 USA and is expected to enrol 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,” says Earl R Fender, president and chief executive officer of VertiFlex. “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 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 Systemis 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 utilising 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 USA since March 2013.