Healthcare Professionals

Magnifuse DBM Family of Products

Bone Grafting (Spine and Orthopaedic)

Overview

The Magnifuse™ Family of demineralized bone graft material is used as a bone graft substitute or a bone void filler. Magnifuse Bone Graft is a combination of aseptically processed demineralized bone matrix (DBM) fibers and surface-demineralized chips, delivered in a resorbable mesh containment system.

Magnifuse Bone Graft substitute/bone void filler is osteoinductive and osteoconductive.

Magnifuse II Bone Graft is a combination of surface demineralized cortical chips and allograft fibers that have been processed removing the mineral component leaving only the organic portion. Bone void fillers (BVF) containing DBM have been shown to have osteoinductive potential when tested in an athymic rat assay.1* Magnifuse II DBM is unique in that it is assembled with autograft tissue in a 1:1 matrix using a disposable plastic funnel and plunger and placed inside the resorbable mesh bags provided.

Magnifuse II Bone Graft does not use a carrier, providing a large volume of allograft per cc. The mesh bag is comprised of polyglycolic acid (PGA), commonly used in absorbable sutures.


INDICATIONS

Magnifuse Bone Graft

Magnifuse Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone.

Magnifuse Bone Graft may be used in a manner comparable to autogenous bone or allograft bone.

Magnifuse II Bone Graft

Magnifuse II Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., the posterolateral spine and pelvis) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. Magnifuse II DBM is resorbed/ remodeled and replaced by host bone during the healing process.


PRODUCT DETAILS

Magnifuse is built off the Grafton™ fiber technology and history. It is the most inductive3 when compared to the major brands currently on the market (internal pre-clinical models). The patented handling and containment options are unmatched by any product currently available on the market.

We take the extra step in our processing to measure the activity of growth factors in our demineralized bone matrices (DBM) using the in vivo athymic rat assay versus only measuring the amount of growth factors in our DBMs using the standard OI model developed by Marshall Urist.1

Our DBM products are some of the most osteoinductive DBMs currently available on the market. We achieve this through painstakingly processing allograft tissues in a manner that preserves the natural growth factors present in the allograft.

COMPONENTS

Magnifuse Bone Graft has three different components: bone fibers, bone chips, and mesh.

Bone Fibers

The demineralized bone fibers in the Magnifuse Bone Graft are processed aseptically to help maintain the naturally occurring growth factors that are present in bone. These growth factors include:2,3

  • BMP-2
  • VEGF
  • TGF-B
  • PDGF

Medtronic was the first to market with a fiber based DBM. Our aseptically processed fibers have some of the highest osteoinductive scores on the market and these interconnected fibers also enhance the osteoconductive potential of the product by providing a path for cellular infiltration.4*

Bone Chips

The surface demineralized bone chips in the Magnifuse Bone Graft construct help facilitate cell attachment and also provide some structural support to resist the compressive forces of the surrounding soft tissue. These chips also show up on X-ray because the cores of the chips still contain mineral components.

Mesh

The PGA resorbable mesh provides a vehicle for delivery and containment. The mesh bag is made of a resorbable material that allows for cellular infiltration and allows the exchange of fluids in and outside of the construct. The mesh bag is temporary and will slowly breakdown through the process of hydrolysis, losing its structural integrity in two weeks.†5 The PGA mesh bag will break down into water and carbon dioxide and is removed by the body's normal metabolism.5

Containment and Delivery

The Magnifuse Bone Graft mesh containment technology offers a unique advantage in that you can have improved handling and containment, but no detrimental effect to inductivity by adding a carrier. Carriers can get in the way of the cells and can mask the osteoinductive signal of the naturally occurring growth factors. The mesh allows the cells to migrate to and infiltrate the matrix of collagen fibers and surface demineralized chips.5

Once hydrated, Magnifuse Bone Graft becomes more moldable and can be pressed into place, accommodating a variety of irregular anatomic surfaces.

Magnifuse II Bone Graft is assembled at the time of use by the clinician. The clinician is able to combine the provided demineralized allograft with the recovered local autograft and then pack into a unique self-contained resorbable mesh using the disposable funnel and plunger. The surgeon can then place a fully contained construct in bone voids.

  • Utilizes patented demineralized fiber technology
  • PGA mesh bag provides a self-contained delivery mechanism
  • PGA mesh bag helps prevent graft migration
  • Disposable instruments facilitate the assembly process
  • Radiopaque for assessment of graft location
  • Conforms to patient anatomy

In vitro testing shows mesh bag breakdown in a fluid environment.5

Mass loss over time as mesh material degrades in vitro.

Performance

In addition to standard osteoinductivity testing, we test our products in other animal models to validate the performance of our products.*

  • Magnifuse Bone Graft: Rat 2-level spinal fusion resulted in 100% fusion at 8 weeks.5
  • Magnifuse II Bone Graft: Rabbit single-level posterolateral spine fusion (6 animals per group, 12 single level fusion masses assessed for fusion) resulted in 100% fusion at 8 weeks.5

Magnifuse Bone Graft is built off of the Grafton™ fiber technology and history. It is the most inductive3 when compared to other major brands currently on the market (internal preclinical models). The patented handling and containment options are unmatched by any product currently available on the market.


SMART STORAGE COMPATIBLE

An RFID-based, near real-time tissue tracking system

 

The Smartstorage™ System is an RFID-based, near real-time tissue tracking system that streamlines inventory management. No more worrying about manual recordkeeping — the Smartstorage System keeps accurate usage history and temperature logs. The system also notifies you when conditions need to be checked and assures precise accountability.


MANUALS AND TECHNICAL GUIDES

Find these technical manuals in the Medtronic Manual Library, in the product labeling supplied with each product, or by calling Medtronic at 800-961-9055.


MAGNIFUSE: CONTRAINDICATIONS

The following are contraindications for the use of Magnifuse™ DBM Bone Graft and Magnifuse™ II Bone Graft:

  • The presence of infection at the transplantation site.
  • Treatment of spinal insufficiency fractures

MAGNIFUSE: CAUTION

This product may contain trace amounts of antibiotics (gentamicin), surfactant, and other solutions used in processing the bone tissue as well as the PGA mesh. Caution should be exercised if the patient is allergic to these antibiotics or chemicals.

For more details see Indications, Safety, and Warnings.


*

Animal testing is not necessarily indicative of human clinical outcome.

Data on file.


1

Edwards JT, Diegmann MH, Scarborough NL. Osteoinduction of human demineralized bone: characterization in a rat model. Clin Orthop Relat Res. (357):219-28, 1998.

2

M. M. Hurley, R. Z. Florkiewicz (1996) Fibroblast Growth Factor and Vascular Endothelial Cell Growth Factor Families. In Bilezikian J. & Raisz L. (EDs), Principles of Bone Biology 627-645.

3

Shun-ichi Harada, Kenneth A. Thomas (2002). Vascular Endothelial Growth Factors. In Bilezikian J. & Raisz L. (EDs), Principles of Bone Biology 883-902.

4

Martin et al.; Spine 24(7). 1991 pp;637-645.

5

Data on file. Animal testing is not necessarily indicative of human clinical outcome.