Indications, Safety, and Warnings
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
INFUSE® BONE GRAFT/INTER FIX™ RP THREADED FUSION DEVICE
The Infuse® Bone Graft/Medtronic Titanium Threaded 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/Medtronic Titanium Threaded Interbody Fusion Device consists of two components containing three parts – a metallic spinal fusion cage, a recombinant human bone morphogenetic protein and a carrier/scaffold for the bone morphogenetic protein and resulting bone. These components must be used as a system for the prescribed indication described above. The bone morphogenetic protein solution component must not be used without the carrier/scaffold component or with a carrier/scaffold component different from the one described in this document. The Infuse® Bone Graft component must not be used without the Medtronic Titanium Threaded Interbody Fusion Device component.
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/Medtronic Titanium Threaded 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.
