Healthcare Professionals
Grafton™ DBM Family of Products
Bone Grafting (Spine and Orthopaedic)
Overview
Grafton™ demineralized bone matrix (DBM) is the most utilized and scientifically studied DBM brand.* Our aseptic processing technology preserves the function of naturally occurring growth factors — yielding Grafton™ DBM’s consistently high osteoinductivity scores.† Proprietary fiber technology offers enhanced osteoconductive scaffold.1
INDICATIONS
Grafton™ DBM demineralized bone fibers (DBF) can be used in orthopedic or reconstructive bone grafting procedures. The product can also be used in bone grafting procedures in combination with autologous bone or other forms of allograft bone, or alone as a bone graft. Contraindications the presence of infection at the transplantation site is a contraindication for the use of this allograft.
PROVEN TECHNOLOGY
Medtronic's processing facility, located in Eatontown, New Jersey, is accredited by the American Association of Tissue Banks (AATB), and is committed to providing quality and innovation in its various demineralized bone matrix tissue forms.
The proprietary demineralization process inactivates viruses while preserving the osteoinductive activity necessary for new bone formation. The D-Min™ process ensures the viral inactivation and osteoinductivity of demineralized bone matrix.2,3
Proven Bone Healing
- Grafton™ DBM has over 25 years of clinical history.
- Grafton™ DBM has been used in over 1.5 million surgeries.‡
- Proven in prospective clinical studies.4,5,6
- Validated process consistently produces an osteoinductive finished allograft.2,3
- And a fiber technology proven to be osteoconductive in a preclinical outcomes study.1†
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 this interconnected mesh of fibers enhances the osteoconductive potential of the product by providing a path for cellular infiltration.
Aseptic Processing for More Consistency
Because allograft tissue processing, including demineralization, has evolved over time and is performed by numerous processors, it is important to recognize that not all demineralization processes are alike. Process variables include:
- Acid concentration and soak time for demineralization
- Temperature
- Use of peroxides
- Application of defatting agents such as ethanol
- Aseptic processing methods versus those employing ethylene oxide or terminal sterilization
At Medtronic, we use our proprietary D-Min™ process to demineralize the allograft tissue that goes into the different Grafton™ DBM forms. Controls in the D-Min™ process eliminate many of the variables that can affect the osteoinductivity of demineralized bone matrix. Through a prospective randomized study of production allograft, we were able to validate that the D-Min™ process yields a consistently osteoinductive product. Product processing consistency is confirmed via ongoing testing.†
Medtronic follows AATB guidelines in sourcing donors and works to maximize the use of donated tissue.
Medtronic conducted an extensive study assessing the impact of age and gender on osteoinductivity. Osteoinductivity scores for each age group and gender were determined using an in vivo athymic rat assay. Donors were grouped in the age ranges specified. Insufficient numbers of 76-85-year-old females resulted in exclusion from analysis. The orange bars represent results from female donors and the blue bars represent male donors.7
PRODUCT DETAILS
Grafton™ DBM is the most utilized DBM brand available. It is comprised of multiple forms, each with unique handling characteristics designed to extend or replace autogenous bone in a variety of challenging bone grafting procedures. Grafton™ is a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e. spine, pelvis, extremities) not intrinsic to the stability of the bony structure. Contraindicated for use in the presence of infection at the transplant site.
CARRIER FREE FIBER TECHNOLOGY
Grafton™ DBF
Grafton™ DBF is a demineralized bone allograft consisting of demineralized cortical fibers. This graft is moldable and may be hydrated with either sterile saline, sterile water, blood or BMA and can be combined with allograft or autograft for use in spinal fusion procedures, as well as any bone void where fusion is desired. Grafton™ DBF is regulated as a Human Cellular Tissue Product solely under 21 CFR, part 1271 so a 510K is not required.
Common Uses: Spine, Trauma, Pelvis, Extremities
GRAFTON™ DBF Inject
Grafton™ (Demineralized Bone Fiber) DBF Inject is a demineralized bone allograft consisting of demineralized cortical fibers derived from cadaveric donor. This graft comes pre-loaded in a syringe with minimally invasive accessories that allow the product to be delivered through most retractor systems and helps facilitate spine fusion procedures, as well as any bone voids where fusion/union is desired.
PREFORMED FIBER TECHNOLOGY
GRAFTON™ FLEX
Grafton™ Flex is a flexible sheet that can be applied whole, or cut into strips or smaller pieces.
Common Uses: Trauma, Extremities
GRAFTON™ MATRIX
Grafton™ Matrix has a unique trough-like design that allows for use with allograft/autograft bone. Two grafts per package.
Common Uses: Spine
GRAFTON™ STRIPS
Grafton™ Strips are long, narrow strips of demineralized bone matrix that overlap for contiguous bone graft contact. Two grafts per package.
Common Uses: Spine
FIBER TECHNOLOGY
GRAFTON™ CRUNCH DBM
Grafton™ Crunch DBM is a ready-to-use mixture of demineralized bone fibers and demineralized cortical bone chips that packs into bone defects.
Chip Size: 2mm–4mm
Common Uses: Spine, Trauma, Pelvis, Extremities
GRAFTON™ PUTTY
Grafton™ Putty consists of demineralized bone fibers and can be mixed with either allograft or autograft bone.
Common Uses: Spine, trauma, pelvis, extremities
GRAFTON™ ORTHOBLEND—LARGE, GRAFTON™ ORTHOBLEND—SMALL
Available in two distinct formulations, Grafton™ Orthoblend combines demineralized bone fibers with cancellous chips or crushed cancellous chips.
LG Chip Size: 2mm–10mm.
SM Chip Size: 0.1mm–4mm
Common Uses: Spine, Trauma, Pelvis, Extremities
INJECTABLE (NON-FIBER)
GRAFTON™ PASTE
Grafton™ Paste is moldable and can be mixed with allograft or autograft bone.
Common Uses: Spine, Trauma, Pelvis, Extremities
GRAFTON™ GEL
Grafton™ Gel can be injected percutaneously and can be mixed with cancellous chips.
Common Uses: Trauma, Extremities
SMART STORAGE COMPATIBLE
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.
ALLOGRAFT RESOURCE CENTER
Medtronic Allograft Tissue is used in surgical applications from head to toe, with features, benefits, shapes, sizes, and delivery methods designed to support fusion success. Visit the Allograft Resource Center for resources you may need to download.
CONTRAINDICATIONS
The following are contraindications for the use of GRAFTON™ DBM and GRAFTON PLUS™ DBM:
- The presence of infection at the transplantation site.
- Treatment of spinal insufficiency fractures.
CAUTION
This allograft may contain trace amounts of antibiotics (gentamicin), surfactant, and other processing solutions. Caution should be exercised if the patient is allergic to these antibiotics or chemicals. Grafton Plus™ DBM Paste contains starch. Therefore, caution should be exercised in using Grafton Plus™ DBM Paste in a patient with a starch allergy and/or amylase deficiency.
For more details see Indications, Safety, and Warnings.
*
Based on Pub-Med search on 8/26/14 with keywords Grafton™, DBX™ and Osteosponge™.
†
Data on file. Animal testing is not necessarily indicative of human clinical outcome.
‡
Based on internal sales data.
1
Martin GJ, Boden SD, Titus L, Scarborough NL New Formulations of Demineralized Bone Matrix as a More Effective Graft Alternative in Experimental Posterolateral Lumbar Spine Arthrodesis. Spine. 1999;24(7):637-645.
2
Khan SN, Fraser JF, Sandhu HS, Cammisa FP, Girardi FP, Lane JM. Use of osteopromotive growth factors, demineralized bone matrix, and ceramics to enhance spinal fusion. J Am Acad Surg. 2005; 13(2):129-137.
3
Scarborough N, White E, Hughes J, Manrique A, Poser J. Allograft Safety: Viral Inactivation with Bone Demineralization. Contemp Orthop. 1995 Oct; 31(4): 257-61.
4
Anand N, Baron EM, Thaiyananthan G, Khalsa K, Goldstein TB. Minimally invasive multilevel percutaneous correction and fusion for adult lumbar degenerative scoliosis: a technique and feasibility study. J Spinal Disord Tech 2008;21:459-67.
5
Cammisa FP, Lowery G, Garfin SR, Geisler FH, Klara PM, McGuire RA, Sassard WR, Stubbs HA, Block JE. Two-year fusion rate equivalency between Grafton™ DBM Gel and autograft in posterolateral spine fusion. Spine. 2004;29(6):660-666.
6
Kang J, An H, Hilibrand A, Yoon ST, Kavanagh E, Boden S. Grafton™ and local bone have comparable outcomes to iliac crest bone in instrumented single-level lumbar fusions. Spine 2012;37:1083-91.
7
Traianedes K, Russell JL, Edwards JT, Stubbs HA, Shanahan IR, Knaack D. Donor Age and Gender Effects on Osteoinductivity of Demineralized Bone Matrix. Appl Biomater 70B:21-29, 2004.