�The US Food and Drug Administration (FDA) has expanded Titan Spine's ENDOSKELTON� TA Vertebral Body Replacement Device (VBR) 510k to include an Interbody Fusion Device indicant.
Under its expanded 510K indication, the Endoskeleton� TA Interbody Fusion Device is approved for use in skeletally grow patients with Degenerative Disc Disease (DDD) at 1 or two contiguous levels from L2-S1. Degenerative Disc Disease is defined as discogenic back up pain with degeneration of the phonograph record confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should cause received six months of non-operative treatment prior to treatment with the devices. The device may be used with supplemental fixing.
While degenerative disc disease is well-nigh often treated by more than conservative therapies, the condition can oft lead to more life-threatening disorders, such as lumbar spinal stricture (narrowing of the spinal canal) or spondylolistheses (disk slips onwards).
"This is an important step for Titan Spine as it gives the surgeon the ability to utilize the Endoskeleton� TA as an Interbody Device while taking off the VBR label, as comfortably 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.
Titan Spine expects that this new product indication will increase product adoption among a group of surgeons that ar focused both on proficiency proficiency and positive, predictable outcomes for their patients. Kevin Gemas, President of Titan Spine, underscored the importance of the expanded classification by adding "with an estimated 65
