The US Food and Drug Administration (FDA) has cleared Baxano's new iO-Tome instrument, designed to remove the facet joint, which is commonly performed in spinal fusion applications.
Utilizing iO-Flex technology, the iO-Tome instrument delivers a new MicroBlade Shaver design to remove the facet joint.
North Carolina based neurosurgeon Robert Isaacs said one of the more technically challenging steps of a less invasive fusion procedure such as a transforaminal lumbar interbody fusion (TLIF) is performing a good facetectomy.
"This new instrument can change this step to be simple, fast, safe and repeatable in all hands and could reduce the learning curve significantly," Isaacs added.
IO-Flex technology initial evaluator and orthopedic spine surgeon Gurvinder Deol said the instrument creates a precise window at the treatment level that provides direct visualization of the neural structures and clear access to the disc for placement of the selected interbody implant.
"It will be especially helpful in procedures where the surgeon is trying to minimize the exposure size, such as many of the emerging midline fusion techniques that require a facetectomy," Deol added.
Baxano president and chief executive officer Tony Recupero said,"The development of an efficient instrument that has the potential to save substantial OR time, provide reproducible results, and is compatible with emerging spinal fusion technologies further highlights the capabilities of our core ‘-inside-out-‘ technology platform."