Baxano, Inc., a medical device company specializing in tools for lumbar decompression procedures, has announced the first patient enrollment for its post-market STRiDE (Spondylothesis Treated with an iO-Flex System Enabled Decompression) study.
The FDA approved iO-Flex system is a flexible set of tools designed to address central, lateral recess and foraminal lumbar stenosis using minimally invasive procedures for decompression.
According to the press release:
The STRiDE study will evaluate the effectiveness of the iO-Flex system in treating patients with moderate to severe spinal stenosis with stable grade 1 degenerative spondylothesis compared to the current standard of care. The study aims to enroll up to 150 patients in 30 centers throughout the U.S.. The primary end-point at 2 years is a responder analysis which will be based on significant changes in Oswerty Disability Index scores. Changes in additional patient reported outcomes will be reported at six months and annually out to 5 years.
More information on the system can be found at the iO-Flex product page…