Baxano has enrolled the first patient into its post-market STRiDE (Spondylolisthesis treated with an iO-Flex system enabled decompression) trial. The study is designed to evaluate the effectiveness of the system in treating patients having moderate to severe lumbar spinal stenosis with stable grade I degenerative spondylolisthesis compared to the current standard of care.
Anthony Asher, national principal investigator for the trial, said, “The focus of all stakeholders in the medical system has shifted dramatically towards critical analyses of quality and cost in healthcare delivery. In that regard, innovative strategies and technologies primarily designed to improve the value of medical interventions are re-shaping the way we deliver 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. Based on preliminary analyses, we believe 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.”
The landmark STRiDE trial will enrol 150 patients in up to 30 leading centres across 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 out to five years. These outcomes will be compared to objective performance criteria established by the current standard of care.
Jed Vanichkachorn, orthopaedic spine surgeon at Tuckahoe Orthopaedics in Richmond, USA, performed the first clinical study case. He said, “The iO-Flex system is a breakthrough technology in the field of lumbar spinal decompression, which has allowed me for the first time to perform a minimally invasive facet sparing decompression for patients with spondylolisthesis and stenosis. I look forward to further evaluating this technology in the STRiDE study.”
The FDA-cleared iO-Flex system is the first minimally invasive set of flexible instruments designed to precisely target central, lateral recess and foraminal lumbar stenosis without disrupting spinal anatomy critical for maintaining spinal stability. It offers the only decompression alternative able to decompress up to four nerve roots on both sides of the spine through one small incision to minimise muscle trauma.
Baxano is also currently enrolling its first post-market study, “Evaluation of the Baxano iO-Flex system for decompressive lumbar surgery,” at 20 sites throughout the USA. This study is designed to further showcase the effectiveness and economics of the system in treating patients with lumbar spinal stenosis. Enrolment is expected to be completed in early 2012.