PLAINSBORO, N.J., May 4, 2009 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today the launch of the Atoll(TM) Occipital-Cervical-Thoracic (OCT) System, a posterior cervical spinal fixation system. With the addition of the Atoll(TM) OCT System, Integra Spine now offers spinal fusion solutions throughout the entire spine, from occiput to sacrum.
The Atoll(TM) OCT System received 510(k) clearance from the United States Food and Drug Administration (FDA) to be marketed in the United States in late March and is currently available in limited release. Full product launch is expected mid-summer 2009.
Posterior cervical spinal fusion is growing in popularity. An estimated 51,000 procedures will be performed in the United States in 2009. Posterior cervical fusion refers to stabilization of the cervical spine (neck) through various instrumentation techniques. Such procedures may be necessary following vertebral neck fractures, correction of cervical instability, cervical deformities, along with tumor resections, or to aid prior failed anterior fusions.
During a posterior cervical fusion procedure, titanium rods, plates, hooks and screws are used in combination to hold multiple levels of the cervical spine together. These components act as an internal brace to stabilize the structure sufficiently to allow for the progression of boney fusion.