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news.Integra LifeSciences Holdings, an integrated medical device company involved in regenerative medicine, has launched a new series of intervertebral body fusion devices, the Vu e-POD and Vu L-POD, through the newly formed Integra Spine, a provider of fusion implants, motion preservation devices and orthobiologics.
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The Vu e-POD and Vu L-POD received clearance from the FDA to be marketed as a spinal intervertebral body fusion device (IBD). Prior to receiving the IBD status, the devices were cleared by the FDA as spinal vertebral body replacement devices (VBRs).
According to the company, 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 technique of distraction during insertion reportedly 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, the company said.
Randy Theken, president of Integra Spine, said: 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.