Baxano out of San Jose, California won the European CE Mark approval for its iO-Flex System for use in spinal decompression surgery. The system, which already has FDA clearance, allows for decompression of up to four nerve roots through one laminotomy.
The company believes using the product may help reduce OR time and shorten hospital stays following surgery.
From the product page:
The iO-Flex® System utilizes thin, flexible instruments to provide precision lumbar decompression from the “inside out.” The intuitive, controlled “over the wire” system is designed to:
- Target and decompress bone and soft tissue in the foramen, lateral recess, and central canal
- Preserve facet joint integrity, thus maintaining biomechanical stability1 and bone for fusion fixation
- Minimize muscle trauma by allowing decompression of up to 4 nerve roots through a single-point access
Product page: iO-Flex System
Press release: Baxano Receives CE Mark for iO-Flex® System
Flashback: Baxano Announces First Patient Enrollment in iO-Flex STRiDE Trial