Integra LifeSciences has received 510k clearance from the US Food and Drug Administration (FDA) for three new spinal intervertebral body fusion devices (IBD) - Cervical Stand-alone, Vu cPOD(TM) Non-Strut and Steerable.
IBDs are small hollow spinal implants that are inserted into the intervertebral space to restore physiological disc height and to allow fusion between vertebral bodies.
These devices relieve pressure on the nerves and associated back pain by maintaining the natural disc space height and by providing positive mechanical stabilization of the vertebrae.
The graft window in the device allows natural bone growth to occur through the IBD and form a strong vertebral union that incorporates the implant.
Each system was engineered to help simplify the surgical procedure and eliminate unnecessary steps.
The systems are currently in limited commercial release and are targeted for full commercial release later this year.
Integra is also leveraging its business development expertise by actively pursuing licensing deals with Stout Medical and Integra for a minimally invasive expandable interbody device.