ENDOSKELETON: A New Device for Degenerative Disc Disease
posted in Spine Surgery Products, Degenerative Disc Disease, What's New
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Titan Spine’s ENDOSKELETON(R) TA Vertebral Body Replacement Device (VBR) received an expanded 510k indication to include an Interbody Fusion Device indication.
As such it is now approved for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. Degenerative Disc Disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies.
While degenerative disc disease is most often treated by more conservative therapies, the condition can often lead to more severe disorders, such as lumbar spinal stenosis (narrowing of the spinal canal) or spondylolistheses (disc slips forward).
“This is an important step for Titan Spine as it gives the surgeon the ability to utilize the Endoskeleton(R) TA as an Interbody Device while taking off the VBR label, as well as the ability to feel comfortable knowing that they now have the option to use the device in a stand-alone setting,” said Steve Cichy, Vice President of Sales of Titan Spine.
The ENDOSKELETON(R) TA is a unique Titanium cage that sits on the strongest portion of the lumbar endplate, yielding excellent resistance to subsidence and expulsion. Coupled with a large open area for bone graft, the device’s acid-etched Titanium surface serves to provide a strong press fit and boney ingrowth.
www.titanspine.com
SOURCE: Titan Spine
Titan Spine, LLC
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