Enrollment in Baxano Trial Begins

Baxano Inc. has enrolled the first patient in its post-market STRiDE (Spondylolisthesis Treated with an iO-Flex System-enabled Decompression) trial. The study is designed to evaluate the system’s effectiveness in patients with moderate to severe lumbar spinal stenosis (narrowing of the spine) with stable grade I degenerative spondylolisthesis compared with the current standard of care.

“In this clinical study, our objective is to compare the outcomes of patients treated with the Baxano iO-Flex System to outcomes achieved in similar clinical conditions using much more invasive and expensive technologies,” said Anthony Asher, M.D., national principal investigator for the trial. “Based on preliminary analyses, we believe that the iO-Flex System has the potential to revolutionize the care of patients with spinal disorders by allowing decompression of neural structures on par with more invasive techniques, thus saving costs and minimizing trauma to healthy tissues.”

The trial will enroll 150 patients in up to 30 centers throughout the United States. The primary endpoint at two years is a responder analysis based on achievement of > / = 15 point change from baseline on the Oswestry Disability Index (ODI). In addition, change in multiple patient reported outcomes from baseline will be assessed at six months and annually for up to five years. These outcomes will be compared with objective performance criteria established by the current standard of care.

The system, which has received U.S. Food and Drug Administration clearance, is the first minimally invasive set of flexible instruments designed to target central, lateral recess and foraminal lumbar stenosis without disrupting spinal anatomy critical for stability. It also is the only decompression alternative able to decompress up to four nerve roots on both sides of the spine through one small incision.

Privately held Baxano is located in San Jose, Calif. The six-year-old firm develops minimally invasive tools to restore spine function and preserve healthy tissue.