iO-Flex system for lumbar spinal stenosis gets Health Canada approval


Baxano has received a medical device license (license # 88060) from Health Canada permitting the company to promote its iO-Flex spinal decompression surgery technology throughout Canada. 

The iO-Flex system is the first minimally invasive set of flexible instruments designed 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. It is the only treatment alternative that is able to reach and remove tissue that creates pressure on multiple nerve roots through a single laminotomy.

“The Canadian marketplace offers Baxano an excellent opportunity to expand the presence of our iO-Flex System to patients suffering from the painful effects of lumbar spinal stenosis,” said Tony Recupero, president and CEO, Baxano. “We believe that the iO-Flex technology has the potential to revolutionise the care of patients with stenosis. Preliminary data from our post market studies, suggest that the iO-Flex system may help reduce the overall health costs associated with the treatment of patients with lumbar spinal stenosis.”