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Artificial Intervertebral Disc Approved by FDA

August 21, 2006 -- The Centers for Devices and Radiological Health has approved the ProDisc-L Total Disc Replacement, an artificial intervertebral disc made from metal and plastic that is used to treat pain associated with degenerative disc disease (DDD). DDD is defined as discogenic back pain (pain resulting from a degenerated intervertebral disc) with degeneration of the disc confirmed by patient history and radiographic studies. The ProDisc-L Total Disc Replacement is implanted to replace a diseased or damaged intervertebral disc during a surgical procedure called spinal arthroplasty.

The ProDisc-L Total Disc Replacement consists of three parts:

  • Two metal (cobalt-chrome alloy) endplates that are anchored to the top and bottom surfaces of the spinal bones (vertebrae)
  • A plastic (ultra-high molecular weight polyethylene, or UHMWPE) inlay that fits between the two endplates
  • The plastic inlay and endplates help restore the natural distance between the two vertebrae (disc height). The top (superior) endplate can slide over the domed part of the inlay, which can allow movement at the level where it is implanted.

The ProDisc-L Total Disc Replacement is indicated for spinal arthroplasty in patients who:

- are skeletally mature
- have degenerative disc disease (DDD) at one level in the lumbar spine (from L3-S1)
- have no more than Grade 1 spondylolisthesis at the involved level
- have had no relief from pain after at least six months of non-surgical treatment

The ProDisc-L Total Disc Replacement is used to replace a damaged intervertebral disc. The device may restore disc height, may reduce pain, and may allow movement at the level where it is implanted.

This device should not be used in patients who have any of the following:

- Active systemic infection or infection localized to the site of implantation
- Osteopenia or osteoporosis defined as DEXA bone density measured T-score - Bony lumbar spinal stenosis
- Allergy or sensitivity to implant materials (cobalt, chromium, molybdenum, polyethylene, titanium)
- Isolated radicular compression syndromes, especially due to disc herniation
- Pars defect
- Involved vertebral endplate dimensionally smaller than 34.5mm in the medial-lateral and/or 27mm in the anterior-posterior directions
- Clinically compromised vertebral bodies at affected level due to current or past trauma
- Lytic spondylolisthesis or degenerative spondylolisthesis of Grade > 1

Additional information: Summary of Safety and Effectiveness and labeling are available at: https://www.fda.gov/cdrh/pdf5/p050010.html.

Source: The Centers for Devices and Radiological Health

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