Baxano, Inc., a Silicon Valley-based medical device company and manufacturer of the iO-Flex® System for spinal decompression surgery, announced today that it has received CE Mark approval allowing for future expansion into European markets.
Lumbar Spinal Stenosis is a degenerative medical condition in which the spinal canal narrows and compresses the spinal cord and nerves in the lumbar area of the spine. Symptoms include pain, weakness, numbness, and tingling in the lower back and legs. Decompression surgery is a common procedure used to treat lumbar spinal stenosis by cutting away the overgrown bone and tissue which causes pressure on the spinal nerves.
Approximately 325,000 decompression procedures are performed in the United States each year to treat lumbar spinal stenosis.
According to Baxano, its FDA-approved flagship iO-Flex System has rapidly gained interest among US spine and neurosurgeons as the first minimally invasive set of flexible instruments designed 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. It is the only treatment alternative that allows surgeons to decompress up to four nerve roots through a single laminotomy.
“This is a major milestone for the company,” said Tony Recupero, President & CEO of Baxano. “Although our immediate focus remains supporting our domestic sales demand, we look forward to working with our international surgeon partners and being able to provide their patients suffering from lumbar spinal stenosis a new minimally invasive surgical option.”
See it in Barcelona this month
Preliminary results from a post market clinical study on the iO-Flex System will be presented by neurosurgeon, Lawrence Dickinson, MD, at the upcoming International Society for the Advancement of Spine Surgery held in Barcelona, Spain, March 20-23rd.
Source: Baxano Inc