Brief Summary of Indications, Contraindications, and Warnings for INFUSE® Bone Graft/LT-CAGE® Lumbar Tapered Fusion Device, INFUSE® Bone Graft/INTER FIX™ Threaded Fusion Device, and INFUSE® Bone Graft/INTER FIX™ RP Threaded Fusion Device
The INFUSE® Bone Graft/Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1, who may also have up to Grade I spondylolisthesis or Grade 1 retrolisthesis at the involved level. The INFUSE® Bone Graft/LT-CAGE® Lumbar Tapered Fusion Device is to be implanted via an anterior open or an anterior laparoscopic approach. INFUSE® Bone Graft with either the INTER FIX™ or INTER FIX™ RP Threaded Fusion Device is to be implanted via an anterior open approach.
The INFUSE® Bone Graft component must not be used without the Interbody Fusion Device component. These components must be used as a system.
NOTE: The INTER FIX Threaded Fusion Device and the INTER FIX RP Threaded Fusion Device may be used together to treat a spinal level.
LT-CAGE Lumbar Tapered Fusion Device implants are not to be used in conjunction with either the INTER FIX OR INTER FIX RP implants to treat a spinal level. The INFUSE® Bone Graft/Interbody Fusion Device is contraindicated for patients with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor, in patients with any active malignancy or patients undergoing treatment for a malignancy, in patients who are skeletally immature, in pregnant women, or in patients with an active infection at the operative site or with an allergy to titanium or titanium alloy.
There are no adequate and well-controlled studies in human pregnant women. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Women of child bearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible orthopedic treatments. The safety and effectiveness of this device has not been established in nursing mothers. Women of child-bearing potential should be advised to not become pregnant for one year following treatment with this device.
Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, definition of DDD, and other important medical information. The package insert also matches the sizes of those sized devices that are indicated for use with the appropriate INFUSE Bone Graft kit.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician with appropriate training or experience.
It is important that you discuss the potential risks, complications, and benefits of the INFUSE® Bone Graft/LT-CAGE® Lumbar Tapered Fusion Device with your doctor prior to receiving treatment, and that you rely on your physician's judgment. Only your doctor can determine whether you are a suitable candidate for this treatment.