Spinal Fusion
 

Spinal Fusion

For patients who require spinal fusion surgery to treat lumbar degenerative disc disease (DDD), Medtronic's Infuse® Bone Graft/LT-Cage® Lumbar Tapered Fusion Device is a treatment option. 

About Spinal Fusion

Many people with lumbar degenerative disc disease (DDD) find relief through nonsurgical options, such as exercise or physical therapy. But for those who need surgery, spinal fusion is a proven choice. And for those who choose spinal fusion, Medtronic offers a therapy that can eliminate the need for an additional procedure to harvest autograft.

The Infuse® Bone Graft/LT-Cage® Lumbar Tapered Fusion Device is designed to aid in the treatment of degenerative disc disease (DDD). It consists of two parts – the LT-Cage Lumbar Tapered Fusion Device and a bone graft alternative* (Infuse Bone Graft). The LT-Cage Lumbar Tapered Fusion Device component is intended to restore the degenerated disc space to its original height. Two implants are placed side by side.

The Infuse Bone Graft component is used to fill the LT-Cage Lumbar Tapered Fusion Device. The Infuse Bone Graft consists of two parts – a solution containing recombinant human bone morphogenetic protein-2 (rhBMP-2) and an absorbable collagen sponge (ACS). The protein is a manufactured (genetically engineered) version of a natural protein normally found in small quantities in the body.

The purpose of the protein is to stimulate bone formation. During surgery, the protein solution is soaked into the ACS. The ACS acts as a scaffold for the formation of new bone that the protein stimulates. The ACS is a sponge manufactured from Type I collagen, and is designed to resorb over time.

Potential Benefit

A potential advantage of spinal fusion surgery with the Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device is that it removes the need to collect iliac crest autograft for use with the LT-Cage Lumbar Tapered Fusion Device, which involves a second or larger incision that may be painful and/or take longer to heal.

Risks

Along with the benefits of this technology, there also may be some potential risks involved with the use of Infuse® Bone Graft/LT-Cage® Lumbar Tapered Fusion Device.

  • There are no adequate and well-controlled studies in human pregnant women.
  • In an experimental rabbit study, the active ingredient in Infuse® Bone Graft, recombinant human bone morphogenetic protein-2 (rhBMP-2), was shown to elicit antibodies capable of crossing the placenta.
  • Women of childbearing potential should ask their physician about the potential risk to a fetus, as well as about other treatment options.
  • The safety and effectiveness of this device has not been established in nursing mothers.
  • Women of childbearing potential should be advised to not become pregnant for 1 year following treatment with this device.
  • The most common and serious adverse events associated with use of the LT-Cage Device include intraoperative vascular injuries, neurological injuries, and retrograde ejaculation in men.

Refer to the Indications, Safety and Warnings for additional important risk information.

* BMPs have been tested as an autograft alternative in multiple clinical studies for certain indications in spine, orthopaedic trauma, and dental.1,2,3,4

References

  1. Burkus, et al. Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages. J Spinal Disorders. 2002:15(5);337-349.
  2. Boyne PJ, Lilly LC, et al. De novo bone induction by recombinant human morphogenetic protein-2 (rhBMP-2) in maxillary sinus floor augmentation. J Oral Maxillofac Surg. 2005:63:1693-1707.
  3. Fiorellini JP, Howell TH, et al. Randomized study evaluating recombinant human bone morphogenetic protein-2 for extraction socket augmentation. J Periodontol. 2005:76(4);605-613.
  4. Friedlaender, et al. Osteogenic protein-1 (bone morphogenetic protein-7) in the treatment of tibial nonunions: A prospective, randomized clinical trial comparing rhOP-1 with fresh bone autograft. J Bone Joint Surg Am. 2001:83-A Suppl 1 (Pt 2);S151-S158.

Patient Selection

The Infuse® Bone Graft/LT-Cage® Lumbar Tapered Fusion Device is indicated for spinal fusion procedures in skeletally mature patients for the treatment of degenerative disc disease (DDD) at one level from L2-S1, who also may have Grade I spondylolisthesis or Grade I retrolisthesis at the involved level. Prior to surgery, patients should have been nonresponsive to at least 6 months of nonoperative therapy.

The Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device should not be used in patients who:

  • Are pregnant or who suspect they may be pregnant
  • Are sensitive to titanium, titanium alloy, bovine Type I collagen or recombinant human bone morphogenetic protein-2 (rhBMP-2)
  • Have an infection near the area of the surgical incision
  • Have had a tumor removed from the area of the implantation site or currently have a tumor in that area
  • Have bones that have not stopped growing
     
Last updated: 22 Sep 2010

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