Baxano has concluded patient enrolment in its iO-Flex system study, designed to evaluate the efficacy of the device in decompressing patients with moderate to severe lumbar spinal stenosis, a degenerative medical condition in which the spinal canal narrows and compresses the spinal cord and nerves in the lumbar area of the spine.
The iO-Flex system is a minimally invasive flexible instrument that allows surgeons to target lumbar stenosis in the central canal, lateral recess and neural foramen with minimal disruption to the patient's healthy anatomy, which is critical for maintaining spinal stability.
The iO-Flex system family of tools include Guidewire, Ipsi or Contra probe, Neuro Check device, MicroBlade Shaver instrument and Distal Handle.
The intuitive, controlled, 'over the wire' system is designed to preserve facet joint integrity, thereby maintaining biomechanical stability and bone for fusion fixation, and minimise muscle trauma by allowing decompression of up to four nerve roots through a single-point access.
The preliminary results demonstrated that patients treated with the iO-Flex system showed a decrease in leg and back pain, with a clinical improvement in lower back function, while experiencing shorter surgical times and decreased hospital length of stay.
San Francisco / Bay Area neurosurgeon and one of the study's lead investigators, Lawrence Dickinson, said patients treated with the iO-Flex system 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 added.
South Carolina neurosurgeon Sumeer Lal said the iO-Flex system provides surgeons a new option to thoroughly address lumbar spinal stenosis without compromising the stabilising structures of the spine.
"For some patients, I have been able to reduce the need, and therefore cost, of spinal implants required for their procedures and I have also been able to send them home sooner. These results are very promising for patients suffering from lumbar spinal stenosis," Lal added.
The company said it will continue to follow all patients in the study for up to two years and collect the clinical outcomes to further support the economic value of the new technology.
Image: The iO-Flex system from Baxano demonstrated a decrease in leg and back pain and improvement in lower back function in the interim study. Photo courtesy of: Baxano.