KEY POINTS
- INFUSE® Bone Graft is a revolutionary bone graft that helps stimulate natural bone formation and remodeling and avoids the need for harvesting bone from other parts of a patient’s body.
- Infuse has been on the market since 2002 and has been used in more than 1 million patients worldwide. Infuse is indicated for certain spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) from L2 to S1, as well as for treating certain acute, open tibial shaft fractures. Infuse is also approved for certain oral-maxillofacial procedures.
- Infuse Bone Graft is one of the most extensively studied commercially available products in Medtronic’s Spine division. Since initially approving Infuse for the treatment of lumbar DDD in 2002, Medtronic submitted additional clinical data to FDA to support the safety and effectiveness of Infuse in other indications, and based upon these submissions gained approval in the tibia trauma and dental indications. More recently the FDA has approved expansions to the original spine indications.
- As with any medical device, there are risks associated with Infuse Bone Graft. These risks are disclosed, among other places, in the FDA-approved product labeling, which includes the listing of potential adverse events.
Overview
- Revolutionary Bone Graft System
Infuse is an FDA-approved revolutionary bone graft that helps stimulate natural bone formation and remodeling, and avoids the need for harvesting bone from other parts of a patient’s body. Infuse contains recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and is approved for use in certain spine, dental, and trauma indications. During surgery, the rhBMP-2 solution is applied to an absorbable collagen sponge, which delivers the rhBMP-2 to the implant site and acts as a scaffolding for the formation of new bone. - Important Treatment for Degenerative Disc Disease and Other Conditions
Infuse has been on the market since 2002, and has been used in more than 1 million patients worldwide.1 Infuse is indicated for certain spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) from L2 to S1, as well as for treating certain acute, open tibial shaft fractures. Infuse is also approved for certain oral-maxillofacial procedures. Infuse eliminates the need to harvest bone from the patient’s body (autograft) in an additional procedure.
Infuse is indicated for the treatment of lumbar degenerative disc disease (DDD), a significant issue that is increasing as the population ages. Worldwide, years lived with disability caused by low back pain have increased by 54% between 1990 and 2015.2 In the United States, low-back pain costs Americans at least $50 billion in health care costs each year—but add in lost wages and decreased productivity and that figure increases.3 Patients with a variety of spinal conditions, like DDD, undergo spinal fusions to treat degenerative changes in the lumbar spine. Infuse Bone Graft remains an important treatment option for doctors performing those surgeries. - Extensively Tested and Studied for Safety
With more than a decade of clinical application, Infuse Bone Graft has become one of the most extensively studied biologic agents commercially available today. Since initially approving Infuse for the treatment of lumbar DDD in 2002, Medtronic submitted additional clinical data to FDA to support the safety and effectiveness of Infuse in other indications, and based upon these submissions gained approval in the tibia trauma and dental indications. More recently the FDA has approved expansions to the original spine indications.
Infuse has been tested for safety and efficacy in numerous preclinical studies. Clinical data likewise demonstrate the safety and efficacy of Infuse. Clinical studies demonstrate that Infuse achieves fusion in spinal procedures at least as effectively as autograft. Additionally, because treatment with Infuse does not require a secondary bone harvesting procedure, it eliminates the need for a second surgical site, which autograft requires. - Potential Risks Disclosed to Doctors
As with any medical device, there are risks associated with Infuse Bone Graft. These risks are disclosed, among other places, in the FDA-approved product labeling, which includes the listing of potential adverse events. These risks include various complications related to surgical treatment, including infection, pain or discomfort, bone fracture, damage to nearby tissue, foreign body (allergic) reaction, incisional complications, non-union, side effects from anesthesia or the surgical approach, and death (among others). The product labeling also indicates that additional surgery may be necessary to correct some of the potential adverse events listed.
1
Internal sales data.
2
Hartvigsen J et al. Low Back Pain Series: What Low Back Pain Is and Why We Need to Pay Attention. Lancet, June 2018; Volume 391, Issue 10137; p2356-2367.
3
In Project Briefs: Back Pain Patient Outcomes Assessment Team (BOAT). In MEDTEP Update, Vol. 1 Issue 1, Agency for Health Care Policy and Research, Rockville, MD.
Brief statements:
SPINAL INDICATIONS
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
Infuse™ Bone Graft/Perimeter™ Interbody Fusion Device
Infuse™ Bone Graft/Clydesdale™ Spinal System
Infuse™ Bone Graft/Divergence-L™ Anterior/Oblique Lumbar Fusion System
Infuse™ Bone Graft/Pivox™ Oblique Lateral Spinal System
The Infuse™ Bone Graft/Medtronic 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 following interbody devices and surgical approaches may be used with Infuse™ Bone Graft:
- The LT-Cage™ Lumbar Tapered Fusion Device, implanted via an anterior open or an anterior laparoscopic approach at a single level.
- The Inter Fix™ or Inter Fix™ RP Threaded Fusion Device, implanted via an anterior open approach at a single level.
- The Perimeter™ Interbody Fusion Device implanted via a retroperitoneal anterior lumbar interbody fusion (ALIF) at a single level from L2-S1 or an oblique lateral interbody fusion (OLIF) approach at a single level from L5-S1.
- The Clydesdale™ Spinal System, implanted via an OLIF approach at a single level from L2-L5.
- The Divergence-L™ Anterior/Oblique Lumbar Fusion System interbody device implanted via an ALIF approach at a single level from L2-S1 or an OLIF approach at a single level from L5-S1.
- The Pivox™ Oblique Lateral Spinal System implanted via an OLIF approach at a single-level from L2-L5.
The Infuse™ Bone Graft/Medtronic Interbody Fusion Device consists of two components containing three parts – a 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 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. The LT-Cage™ Lumbar Tapered Fusion Device, the Perimeter™ Interbody Fusion Device, the Clydesdale™ Spinal System, the Divergence-L™ Anterior/Oblique Lumbar Fusion System, and the Pivox™ Oblique Lateral Spinal System 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 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, titanium alloy, or polyetheretherketone (PEEK).
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 Infuse™ Bone Graft 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. An electronic version of the package insert may be found at www.medtronic.com/manuals.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician with appropriate training or experience.
Infuse™ Bone Graft has not been tested in pregnant women to determine if it could pose harm to a developing fetus, nor has it been studied in nursing mothers. Women of childbearing potential should not be treated with Infuse Bone Graft immediately prior to or during pregnancy, and should be advised not to become pregnant for one year following treatment. They should be warned of potential risks and should discuss other possible treatments with their doctor.
TIBIA TRAUMA INDICATIONS
BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR:
INFUSE™ BONE GRAFT
Infuse Bone Graft is indicated for treating acute, open tibial shaft fractures that have been stabilized with IM nail fixation after appropriate wound management. Infuse Bone Graft must be applied within 14 days after the initial fracture. Prospective patients should be skeletally mature.
Infuse Bone Graft consists of two components – recombinant human Bone Morphogenetic Protein-2 solution and a carrier/scaffold for the bone morphogenetic protein solution and resulting bone. These components must be used as a system. 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.
Infuse Bone Graft 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 an active malignancy or patients undergoing treatment for a malignancy. Infuse Bone Graft should also not be used in patients who are skeletally immature, in patients with an inadequate neurovascular status, in patients with compartment syndrome of the affected limb, in pregnant women, or in patients with an active infection at the operative site.
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, and other important medical information.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician with appropriate training or experience.
ORAL MAXILLIOFACIAL INDICATIONS
BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, WARNINGS, AND PRECAUTION FOR INFUSE™ BONE GRAFT FOR CERTAIN ORAL MAXILLOFACIAL AND DENTAL REGENERATIVE USES
Infuse Bone Graft is indicated as an alternative to autogenous bone graft for sinus augmentations, and for localized alveolar ridge augmentations for defects associated with extraction sockets.
The Infuse Bone Graft consists of two components – recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) placed on an absorbable collagen sponge (ACS). These components must be used as a system for the prescribed indication. 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 the package insert.
Infuse Bone Graft 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 pregnant women, or patients with an active infection at the operative site.
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 dental 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.
Infuse Bone Graft has not been studied in patients who are skeletally immature
(<18 years of age or no radiographic evidence of epiphyseal closure).
Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.
