Two New FDA Rulings Expand Integra’s Product Offerings

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 environment in which natural bone growth can occur, which then enables fusion of the vertebral segments.”

Traditionally, surgeons use supplemental fixation to help hold the IBD in place. The Integra Vu aPOD Prime IBD features two zero-profile options utilizing two screws or two screws and a SpinPlate to help secure the IBD in its functional position, eliminating the need for supplemental fixation implants, and reducing the number of steps and implants required to perform an ALIF procedure.

“The Integra® Vu aPOD™ Prime IBD provides surgeons with an easy and safer approach when compared to other devices that have four points of fixation with four screws, and a very minimally invasive way to provide stability of the anterior lumbar spine, with no additional sharp objects introduced to the outside of the spine, ” said Jaideep Chunduri, M.D., a design surgeon from Beacon Orthopaedics and Sports Medicine in Cincinnati, Ohio. “It is often difficult to place screws laterally within the lumbar spine. Integra’s SpinPlate™, in conjunction with two screws, enables four-point fixation without significant retraction. Because the SpinPlate™ is also located within the middle of the device, and provides built-in fixation, there is no added risk in terms of blood loss or vascular tissue. “

New Bone Tip

Shortly after announcing its Vu aPOD news, Integra rolled out its latest device at the Chicago Congress of Neurological Surgeons. It is a bone tip for the CUSA NXT Ultrasonic Tissue Ablation System. The new bone tip, which has received FDA clearance, allows surgeons to use ultrasonic tissue ablation in procedures requiring precise, controlled bone removal near critical structures where the rotational motion of a drill or frictional heat could be a concern.

The tip features a working surface oriented towards the bottom surface of the tip, making it useful in situations where the surgical setting requires downward pressure for bone removal. “The orientation of the new tip will help neurosurgeons during cases when they are approaching the bone from above. The tip also generates less heat, which can be important in certain surgical procedures, ” said Bob Davis, President of Integra’s Neurosurgery business. The company reports that over 2, 000 centers now rely on the CUSA ultrasonic surgical ablation technology for a variety of procedures.