Healthcare Professionals

Grafton Demineralized Bone Matrix (DBM)

Bone Grafting (Oral-Maxillofacial and Dental)

  

THE MOST STUDIED DEMINERALIZED BONE MATRIX BRAND

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

The form of Grafton used in dental procedures is Grafton Plugs. These cube-shaped grafts can be placed in bone voids ranging from facet joints to extraction sockets. Size: 8mm × 8mm × 10mm.


INDICATIONS  

Grafton DBM is intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infra bony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.

Grafton DBM may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze-dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. Grafton DBM is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Grafton DBM is resorbed/remodeled and is replaced by host bone during the healing process.


PROVEN DBM 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

Patented Allograft Processing, 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.

Allograft Tissue 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

We use our proprietary D-Min process to demineralize the allograft tissue that goes into the different Grafton Bone Graft 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

Bone Grafting HCP Grafton Osteoconductivity Graph

MANUALS AND TECHNICAL GUIDES

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


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 information, 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. Spine2012;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.