Baxano, a medical device company, has completed enrollment in its iO-Flex Study, which is a post-market clinical performance evaluation of the company's surgical system for decompressing patients diagnosed with moderate to severe lumbar spinal stenosis.
The iO-Flex System is a minimally invasive set of flexible instruments that allow surgeons to target lumbar stenosis in the central canal, lateral recess, and neural foramen with minimal disruption to the patient’s healthy anatomy critical for maintaining spinal stability.
Preliminary results an interim analysis of the data demonstrated patients had a decrease in leg and back pain with a clinical improvement in low back function.
Patients treated with the iO-Flex System have also experienced shorter surgical times and decreased hospital length of stay compared to published clinical data.
San Francisco/Bay Area neurosurgeon and one of the study’s lead investigators Lawrence Dickinson said patients are experiencing rapid, pronounced improvement in symptoms.
"When compared to historical controls, preliminary results suggest patients treated with the iO-Flex System are experiencing shorter hospital stays, less blood loss, and fewer complications," Dickinson said.
Baxano will study all patients in the clinical trial for up to two years and collect the data to further support the economic value the new technology offers healthcare.