Two New FDA Rulings Expand Integra’s Product Offerings (Orthopedics This Week)
Earlier this month, the Food and Drug Administration approved an expanded use for Integra LifeSciences Holdings Corporation’s Vu aPOD, an intervertebral body fusion device (IBD) for use in anterior lumbar fusion (ALIF) procedures. The new indication includes four points of fixation composed of two screws and a SpinPlate.
"Earlier this year the Vu aPOD™ Prime IBD entered its full market release with stand-alone indications," said Kirt Stephenson, president, U.S. Spine. "We're pleased that with this additional indication, we can now provide surgeons with multiple fixation options to best meet their patients' needs."
As Integra’s October 9 release explained, “IBDs are designed to help provide stability for spinal fusion after a diseased lumbar disc is surgically removed. They are small, hollow spinal implants that are inserted into the intervertebral space to restore physiological disc height and allow fusion between vertebral bodies. These devices relieve pressure on the nerves and provide positive mechanical stabilization of the vertebrae. The graft window in the device is packed with bone and provides an...
