Integra LifeSciences Holdings Corporation (Integra) has unveiled series of intervertebral body fusion devices (IBD), the Vu e-POD and Vu L-POD through the newly formed Integra Spine. The Vu e-POD and Vu L-POD received clearance marketing approval from the US Food and Drug Administration (FDA) as a spinal IBD. Before receiving the IBD status, the devices were cleared by the FDA as spinal vertebral body replacement devices (VBR).
The dual classification of the Vu e-POD and the Vu L-POD gives the surgeon a broader range of usages. As an IBD, they are used as an adjunct to fusion in patients with degenerative disc disease at one or two contiguous levels (L2-S1). As a VBR, they may be used to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (T1-L5).
The Vu e-POD’s unique technique of distraction during insertion reduces the amount of steps and instruments required to perform the surgery. This contributes to decreasing the length of time needed to perform the procedure. (US Patent No. 6,290,724 licensed from NuVasive, Inc.)
Randy Theken, president, Integra Spine, states, “The Vu e-POD all-in-one insertion and distraction technique gives Integra Spine a true competitive advantage. It leads to benefits for both the surgeon and patient. No longer is a second instrument required to distract the disc space. It is accomplished through a simple rotation technique performed after inserting the device.”