OVERVIEW OF BONE GRAFTING OPTIONS BONE GRAFTING (Spine and Orthopaedic)

WHAT ARE THE DIFFERENT BONE GRAFTING OPTIONS?

Bone grafts help heal bone by creating new bone (called de novo bone). There are many bone graft technologies that can help achieve this—and substantial differences among them. They work differently, they are made from different materials, and their approved uses vary widely.

Common options for bone grafting include:

• Autograft Tissue
• Allograft Tissue
• Synthetic Bone Graft
• Growth Factors

Autograft Tissue

Taken surgically from one part of your body, autograft tissue is transplanted to another part of your body.

Benefits:

• No potential for immune reaction or disease transmission
• Commonly used in surgery
• Well-documented success
• May heal large or small defects by itself
• Transplanting your own bone forming cells to help heal the defect

Drawbacks:

• Risk of pain and/or infection at harvest site which may last for a long time
• Additional surgery and anesthesia are required
• May not be an option for some patients

Allograft Tissue

Allograft tissue is generously donated by the family of a deceased loved one to enhance the life of another individual.

Benefits:

• Commonly used in surgery
• Well-documented success
• May heal small defects by itself
• Portions of the graft may turn into your own bone
• Demineralized allografts contain active proteins that stimulate your body’s cells to form bone

Drawbacks:

• Minimal risk for disease transmission
• Portions of the graft may remain in your body for years to come
• Limited in its ability to heal large defects by itself

Synthetic Bone Graft

These artificially produced materials bulk up or extend the supply of available autograft bone (bone harvested from your own body).

Benefits:

• Commonly used in surgery
• Not human-derived
• Readily available
• Provides a scaffold onto which your bone cells can attach for new bone formation
• No risk for disease transmission

Drawbacks:

• Synthetics alone do not contain proteins that stimulate your body’s cells to form bone
• Portions of the graft may remain in your body for years to come
• Limited in its ability to heal large defects by itself

Growth Factors

This bone graft is a manufactured (genetically engineered) version of a natural protein normally found in small quantities in the body which regulates bone healing and growth. Infuse™ Bone Graft is a growth factor option from Medtronic.

Benefits of Infuse Bone Graft:

• Commonly used in surgery
• No risk for disease transmission
• Readily available
• Well-documented success
• May heal large defects*
• Proven, predictable bone growth results—bone grows where Infuse Bone Graft is placed

Drawbacks of Infuse Bone Graft:

• Contraindicated for use in patients with an active infection at the defect site
• Should not be used in pregnant women, women who plan to become pregnant in the next 12 months, or women who are nursing
• Should not be used in people with immune deficiencies, due to other treatments, such as radiation therapy, chemotherapy, or steroid therapy

View full list of indications, warnings, precautions, and other important medical information.

BONE GRAFT SELECTION

The type of graft used will depend on a number of factors including, but not limited to, the type of surgery being performed, your age, medical history, and bone quantity/quality. A prescription is required, and you should always consult your surgeon to understand which bone graft is right for you, as well as for a complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.

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.

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.