Infuse Bone Graft Expanded Indications

TRUSTED. PROVEN. PREDICTABLE.


Infuse Bone Graft is now available with expanded indications for oblique lateral interbody fusion (OLIF 25 and OLIF 51 Procedures) and anterior lumbar interbody fusion (ALIF) procedures with certain sizes* of PEEK interbody fusion devices.

New Indications Brochure

SINGLE-LEVEL OLIF25 PROCEDURES* (L2-L5)

Infuse Bone Graft with Pivox and Infuse Bone Graft with PEEK

SINGLE-LEVEL OLIF51 Procedures*
(L5-S1)

Infuse Bone Graft with Divergence and Infuse Bone Graft with PEEK

SINGLE-LEVEL ALIF
Procedures*
(L2-S1)

Infuse Bone Graft with Divergence and Infuse Bone Graft with PEEK

* Refer to the Infuse Bone Graft/Medtronic Interbody Fusion Device package insert for additional information.

NOTE: The Perimeter, Clydesdale, Divergence-L and Pivox devices must be used with any supplemental fixation system cleared for use in the lumbar spine.


Infuse Bone Graft

Infuse Bone Graft

Infuse Bone Graft is the premium product for autograft replacement due to its high osteoinductivity.  With Infuse Bone Graft, the need for a second incision to harvest iliac crest bone from the patient is eliminated. Infuse Bone Graft has proven osteoinductivity that ensures predictable bone formation — giving you confidence in this safe and effective technology. Learn more about Infuse.

DOWNLOAD VOLUME & CONCENTRATION GUIDE

DOWNLOAD HANDLING & FILLING GUIDE

DOWNLOAD PATIENT EDUCATION BROCHURE


The OLIF25 Procedure

OLIF25 Procedure has changed lateral access surgery. It is a complete, minimally invasive solution that enables a psoas-preserving approach away from the posterior nerves and allows easier access around the iliac crest at L4-5.

The OLIF51 Procedure

OLIF51 Procedure is essentially a laterally-positioned, traditional ALIF retroperitoneal approach. The procedure requires less dissection of the retroperitoneal space than an ALIF and can be performed using a smaller incision. The lateral decubitus position provides the anatomic benefits of the patient's entire abdominal contents falling away from the spine.

OLIF25 and OLIF51

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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 childbearing 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 childbearing 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.