Baxano has completed the enrolment of the first patient in its post-market STRiDE (spondylolisthesis treated with an iO-Flex System enabled decompression) trial.
The trial will enrol 150 patients to evaluate the effectiveness of the iO-Flex System in treating patients having moderate to severe lumbar spinal stenosis with stable grade I degenerative spondylolisthesis compared with the current standard of care.
The iO-Flex System is designed to precisely target central, lateral recess and foraminal lumbar stenosis without disrupting spinal anatomy critical for maintaining spinal stability.
The primary endpoint at two years is a responder analysis based on achievement of a 15-point change from baseline on the Oswestry Disability Index and a change in multiple patient reported outcomes from baseline.
Baxano is also enrolling patients in a post-market study to demonstrate the effectiveness and economics of the system in treating patients with lumbar spinal stenosis.
Principal investigator Anthony Asher said that, based on preliminary analyses, the company believes that the iO-Flex System has the potential to revolutionise the care of patients with spinal disorders by allowing decompression of neural structures on par with more invasive techniques, thus saving costs and minimising trauma to healthy tissues.
Enrolment is expected to be complete in early 2012.