Baxano has announced that it has completed enrolment in its iO-Flex study which is a post-market clinical performance evaluation of the iO-Flex system used for decompressing patients diagnosed with moderate to severe lumbar spinal stenosis.
“Patients are experiencing rapid, pronounced improvement in symptoms. Importantly, the surgical response has been sustained,” said Lawrence Dickinson, neurosurgeon, San Francisco, USA and one of the study’s lead investigators. “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 presented positive outcomes from an interim analysis of the data at the American Association of Neurological Surgeons meeting in late April 2012. These preliminary results demonstrated patients had a decrease in leg and back pain with a clinical improvement in low back function. In addition, patients treated with the iO-Flex system have thus far experienced shorter surgical times and decreased hospital length of stay compared to published clinical data.
Baxano 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 the new technology offers healthcare. Inadequately addressing lateral recess and foraminal stenosis in patients with lumbar stenosis have been reported as the number one cause of poor surgical outcomes.
“The iO-Flex System provides surgeons a new option to thoroughly address lumbar spinal stenosis without compromising the stabilising structures of the spine,” said Sumeer Lal, neurosurgeon, Greenville, USA. “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.”
About the iO-Flex system
The iO-Flex system allows 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. According to a company release, it is the only treatment alternative that allows surgeons to decompress up to four nerve roots through a single laminotomy.