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Designing a Better Graft SolutionAs a whole new category in tissue repair, Biodesign is different than synthetic mesh and other biologic grafts in many important ways. Learn about the science behind the design of Biodesign advanced tissue repair versus other categories of tissue repair. Biodesign combines the best attributes of synthetic mesh and biologic grafts, creating a whole new category in tissue repair.BiodesignBiodesign is not prone to encapsulation or erosion, is not chemically cross-linked, and does not leave behind a significant amount of elastin that would make it stretch, leaving the patient prone to a recurrence. It signals the body to encourage complete remodeling, so it becomes strong, organized tissue that functions and moves naturally. Biodesign offers a permanent repair without a permanent material. The signaling process allows the body's own defense mechanisms to reach and respond to infection, making the graft resistant to infection. Additionally, Biodesign is widely available for a moderate price in specially designed shapes and sizes. Biologic GraftsDermis-based biologic grafts are more resistant to infection than synthetic mesh and allow some natural remodeling, but they contain elastin that is left behind and can stretch, sometimes resulting in a recurrence or a "cosmetic hernia". Some biologic grafts are chemically cross-linked in an attempt to compensate for this stretching. However, this can create a biologic graft that will not fully remodel into tissue. Most biologic grafts are also limited in availability and size, and can be cost-prohibitive. Synthetic MeshWhile synthetic mesh is readily available in a variety of shapes and sizes and is fairly inexpensive, it can lead to scarring and encapsulation, is contraindicated in infected fields, and has potential for erosion into surrounding tissue. In some cases synthetic mesh needs to be removed after implant, requiring a second surgery. In 2008, the FDA issued a public health notification regarding complications of synthetic mesh. The presence (or absence) of collagen and elastin in biologic grafts can affect the ability of the device to completely remodel. Complete remodeling of a tissue graft requires that all parts of the material be replaced by new tissue. Dermis, the source of many biologic grafts, contains a significant amount of elastin, which cannot be quickly replaced with new tissue through the body's healing process. Studies show that in non-cross-linked dermis-based biologic grafts, weakening and recurrence may occur over time.1 If elastin is still present, so is the "stretchiness" of the graft. This is likely why dermis-based biologic grafts have been reported to stretch over time,2 leaving a potential for recurrence. The Biodesign AdvantageIn contrast, Biodesign, made from submucosal tissue, contains only trace amounts of elastin and results in a repair that does not suffer from long-term stretching. Biodesign becomes stronger over time. Read more in the Dermis Disconnect white paper.
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1 Jin J, Rosen MJ, Blatnik J, et al. 2 Bluebond-Langner R, Keifa ES, Mithani S, et al. All biologic grafts have some degree of natural cross-linking, but some are also chemically cross-linked during processing. Chemical cross-linking often makes biologic grafts resistant to remodeling. This alters the three dimensional structure of the graft, creating a barrier to cell migration into the material. The body reacts to the graft as if it were a synthetic mesh. Additionally, the chemicals used in processing can also release cytotoxic residues,1 induce calcification of the graft2 and cause the body to react as if the graft is foreign,3 provoking inflammation and encapsulation.4 The Biodesign AdvantageBiodesign is not chemically cross-linked and retains the ability to signal the surrounding tissue to populate the graft with new cells and completely remodel into fully vascularized tissue. Read more in the Cross-Link Disconnect white paper.
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1 Huang-Lee LL, Cheung DT, Nimni ME. 2 Connolly JM, Alferiev I, Clark-Gruel JN, et al. 3 Gandhi S, Kubba LM, Abramov Y, et al. 4 Valentin JE, Badylak JS, McCabe GP, et al. To provide a long-term repair, a tissue graft must provide initial support while guiding tissue ingrowth. Biodesign’s unique ability to signal the body attracts cells and nutrients to the wounded area. The Biodesign graft also provides structural support while the body restores itself. In contrast, a bioabsorbable synthetic mesh does not have biological information to signal or guide cell ingrowth. Thus, any incidental cell growth might not result in functional tissue or a strong repair. A bioabsorbable mesh provides initial support, but weakens over time as it is absorbed by the body. Biodesign offers both initial support and active signaling to completely remodel into fully vascularized tissue that over time becomes as strong as the patient's own tissue. In fact, Biodesign is the only biologic graft with 5 year data supporting long-term strength of repair.1
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1 Franklin ME Jr, Treviño JM, Portillo G, et al. |
