FDA Clears Spinal Company Baxano’s iO-Tome™ Device For Precise Facet Joint Removal

In short

Silicon Valley spinal device company Baxano, Inc., manufacturer of the iO-Flex® System utilised in spinal decompression surgery, has received FDA clearance to market its new iO-Tome™ instrument.

Background

Estimates suggest roughly 300,000 lumbar spinal fusions are performed each year in the United States and spinal device company Baxano develops tools for these very procedures. Indeed the company says it has experienced rapid adoption of its iO-Flex Technology for use in direct lumbar decompressions with and without fusion.

Now with the clearance and release of the iO-Tome device for performing facet joint removal, Baxano also offers spinal surgeons another advanced technology for this procedure, which is commonly performed when performing spinal fusion.
The iO-Tome instrument utilises the company’s flagship iO-Flex platform to deliver a new MicroBlade Shaver® design configured to rapidly and precisely remove the facet joint.
Baxano tells us it will be exhibiting and featuring the complete iO-Flex System including the iO-Tome instrument this month at the annual meetings of both the Congress of Neurological Surgeons (CNS) in Chicago, Illinois and the North American Spine Society (NASS) meeting in Dallas, Texas.

Physician comments

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

“This 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,” stated Gurvinder Deol, MD, an orthopedic spine surgeon performing initial evaluations of the technology in Raleigh, North Carolina. ”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.”

Company comments

“The iO-Tome represents a tremendous step forward into the fusion market for Baxano,” said Tony Recupero, President and Chief Executive Officer. “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.”

Source: Baxano Inc.