AlloFuse® Demineralized Bone Matrix (DBM)
Advancing the Nature of Bone
AlloFuse® DBM Putties, Pastes and Gels are bone graft substitutes composed of demineralized bone matrix in a reverse phase medium. This distinctive reverse phase medium provides exceptional handling and placement characteristics, in moldable and flowable formats designed to balance clinical efficacy, safety and ease of use. Since 2006, AlloFuse® DBM has been implanted in over 500,000 spinal, orthopedic, and other procedures for fusion and bone repair.1 AlloFuse® is clinically proven to be equivalent to autograft at growing new bone.2,3
- Convenient, shelf-stable, sterile, and ready to use directly out of the package with no preparation required
- May be used to fill bone voids, interbody cages, or gaps that are not intrinsic to the stability of the bone structure
- Easily moldable at room temperature, and stiffens once it reaches body temperature in situ to help stay in place
- Sterilized by electron beam irradiation to a Sterility Assurance Level of 10-6 to reduce risk of infectious disease transmission
- Every production batch is tested to ensure the ability to grow new bone utilizing a highly regarded in vivo test to confirm osteoinductive potential
AlloFuse® and AlloFuse® Plus DBM are available in a variety of sizes in moldable and flowable formats designed to balance clinical efficacy, safety and ease of use. AlloFuse® and AlloFuse® Plus DBMs may be packed into bony defects of the skeletal system (i.e., extremities, posterolateral spine and pelvis) as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created, or from the result of traumatic injury to the bone.
AlloFuse® (Gel and Putty)
AlloFuse® Gel and Putty are human bone tissue that have been demineralized, mixed with a reverse phase medium and formulated into a gel or putty-like form. The medium exhibits reverse phase characteristics (i.e., an increase in viscosity as temperature increases).
AlloFuse® Plus (Paste and Putty)
AlloFuse® Plus contains added ground cancellous providing a scaffold to support bone growth. AlloFuse® Plus provides both osteoinductive potential(from the DBM) and an osteoconductive scaffold (from the cancellous bone) supporting bone growth.
Clinical Study
Use of Demineralized Bone Matrix Gel in Foot Surgery: A Prospective Randomized Controlled Study Comparing Demineralized Bone Matrix to Autologous Bone Graft.2
Animal Study
The Demineralized Bone Matrix Provides Equivalent Results to Autograft in Standard Posterolateral Fusion Model in Adult Rabbits.3
REFERENCES
1. Data on File.
2. J. Christiaan Coetzee, M.D. White paper available from AlloSource.
3. W.R.Walsh. White paper available from AlloSource
All necessary regulatory documentation, instructions for use, published studies, patient education tools, etc. (as applicable) can be provided upon request by contacting cs@spartanmedical.com or (888) 240-8091. We are available at any time to meet with providers and staff to answer any questions about Spartan Medical’s entire portfolio of advanced medical solutions.
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