Baxano’s iO-Tome device receives FDA clearance


Baxano has announced has it has received FDA clearance to market its new iO-Tome instrument.

According to a company press release, the iO-Tome instrument uses Baxano’s flagship iO-Flex platform to deliver a new MicroBlade Shaver design configured to rapidly and precisely remove the facet joint, which is commonly performed in spinal fusion applications.

“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,” commented Robert Isaacs, a neurosurgeon from Durham, North Carolina, USA. “This new instrument can change this step to be simple, fast, safe and repeatable in all hands and could reduce the learning curve significantly.”

The press release reported that Baxano has experienced rapid adoption of its iO-Flex Technology for use in direct lumbar decompressions with and without fusion. With the introduction of the iO-Tome device for performing facet joint removal, Baxano now offers these surgeons another advanced technology for patients that require spinal fusion. An estimated 300,000 lumbar spinal fusions are performed each year in the USA.

“This instrument creates a precise window at the treatment level that provides direct visualisation of the neural structures and clear access to the disc for placement of the selected interbody implant,” stated Gurvinder Deol, an orthopaedic spinal surgeon performing initial evaluations of the technology in Raleigh, North Carolina, USA. “It will be especially helpful in procedures where the surgeon is trying to minimise the exposure size, such as many of the emerging midline fusion techniques that require a facetectomy.”