Baxano Receives FDA Clearance for Bone Shaving Device

Baxano Inc., a Silicon Valley-based medical device company, has received clearance from the U.S. Food and Drug Administration for its iO-Tome bone shaving instrument. The product uses the company’s iO-Flex platform, and could help surgeons rapidly and precisely remove the facet joint—the joint between any two vertebra—during spinal fusion procedures.

The “iO” in the product name stands for “inside-out,” an approach to lumbar stenosis that Baxano has developed. The method is designed to shave overgrown tissue and bone in stenosis (a narrowing of the spinal cord) from the inside out to preserve healthy tissue. Access is gained through a fine surgical wire.

“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,” said Robert Isaacs, M.D., a neurosurgeon from Durham, N.C. “This new instrument can change this step to be simple, fast, safe and repeatable in all hands and could reduce the learning curve significantly.”

Baxano has quickly adopted its iO-Flex technology in direct lumbar decompressions with and without fusion. The iO-Tome device uses Baxano’s trademarked MicroBlade Shaver technology to perform the facet removal. An estimated 300,000 lumbar spinal fusions are performed each year in the United States.

“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, M.D., an orthopedic spine surgeon performing initial evaluations of the technology in Raleigh, N.C. “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.”

“The iO-Tome represents a tremendous step forward into the fusion market for Baxano,” said Tony Recupero, company president and CEO. “The development of an instrument that has the potential to save substantial OR [operating room] time, provide reproducible results, and is compatible with emerging spinal fusion technologies further highlights the capabilities of our core ‘inside-out’ technology platform.”

Baxano is based in San Jose, Calif. The company develops flexible tools to perform precision lumbar decompression from the inside out.

Photo of iO-Flex System courtesy of Baxano.