Baxano, a provider of orthopedic flexible tools, has obtained CE mark approval for its iO-Flex System.
The iO-Flex System is a minimally invasive set which is 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.
Baxano said it is the only treatment alternative that allows surgeons to decompress up to four nerve roots through a single laminotomy.
Baxano president and CEO Tony Recupero said the company looks forward to work with its international surgeon partners and being able to provide their patients suffering from lumbar spinal stenosis a new minimally invasive surgical option.
The company has also received the US Food and Drug Administration (FDA) approval for its iO-Flex System.
The iO-Flex System’s preliminary results from a post market clinical study will be presented at the upcoming International Society for the Advancement of Spine Surgery held in Barcelona, Spain from 20-23 March 2012.