The US Food and Drug Administration (FDA) has approved an expanded indication for use of Integra LifeSciences' Vu aPOD Prime intervertebral body fusion device (IBD) in anterior lumbar interbody fusion (ALIF) procedures.
The Vu aPOD Prime features two zero-profile options utilizing two screws and a SpinPlate to help secure the IBD in its functional position and eliminating the need for supplemental fixation implants.
The company said IBDs are designed to help provide stability for spinal fusion after a diseased lumbar disc is surgically removed.
Beacon Orthopaedics and Sports Medicine design surgeon Jaideep Chunduri said 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.
"It is often difficult to place screws laterally within the lumbar spine," Chunduri added.
"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."