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Performance: The AlloDermTM difference

Take a closer look: Regeneration is key
Choose a topic below to read more:

With the handling and pliability surgeons desire, it’s no wonder AlloDermTM RTM is the industry-leading ADM.1-4

Tissue integrity

Not all processing is the same: AlloDermTM RTM processing maintains tissue integrity

AlloDermTM RTM is minimally manipulated and gently processed to ensure it retains components critical to maintaining the biochemical and biomechanical integrity of the native tissue. As an undamaged tissue matrix, the native collagen architecture, including basement membrane structure, is maintained throughout the gentle LifeCell Tissue Process. An intact tissue matrix is vital for a positive immunologic response and regeneration.5-7

Dissimilar collagen structure

Ultrastructural out-of-package morphology of ADMs as compared with native human dermis (1000x magnification scanning electron micrographs) revealed that AlloDermTM RTM had a similar structure to native dermis.
Clinical significance has not been established.

Body’s response

Maintaining tissue integrity is essential to achieving successful biological outcomes

*Correlation of these results, based on animal studies, to results in humans has not been established.

Cell repopulation and revascularization

AlloDermTM RTM supported rapid revascularization, fibroblast
repopulation, and remodeling in a preclinical model

An undamaged tissue matrix supports revascularization and cell repopulation. Damaged matrices experience delayed revascularization, which impedes white blood cell migration and fibroblast formation.6-8,10*

Take a closer look at AlloDermTM RTM
AlloDermTM RTM revealed widespread cellular infiltration with distribution of fibroblasts and numerous blood vessels.11 Damaged tissue matrices have a lack of fibroblast and blood vessel formation.12-14*

Widespread fibroblast &
blood vessel formation

All samples are from 1-month implantation in nonhuman primate (NHP) models in 5 different studies. AlloDermTM RTM, AlloMax®, Flex HD®, and SurgiMend® samples are from 1-month implantation in NHP abdominal wall repair (AWR) models. DermACELL® sample is from 1 month in NHP subcutaneous model. These studies followed the same protocol and were performed at the same institution at different times. Each image is shown stained with Hematoxylin & Eosin (H&E) at 200x magnification. H&E stains collagen fibers pink and cell nuclei blue-purple. Nuclei of lymphocytes are round, fibroblasts are elongated, and macrophages are round and diffuse.
*Correlation of these results, based on animal studies, to results in humans has not been established.

The importance of cell repopulation and revascularization

Supports remodeling

Supports remodeling

Without vascular supply, there is no pathway for cells to remodel the tissue.15

Resists infection

Resists infection

Formation of intact vascular channels allows white blood cells to migrate to the site of an infection to minimize risk.16

Prevents necrosis

Prevents necrosis

Cellularized tissue matrices that do not revascularize will necrose.17

Minimal inflammation

AlloDermTM RTM demonstrated minimal inflammation in a preclinical model

Damaged matrices are viewed by the body as foreign and trigger a chronic inflammatory response that leads to matrix degradation or encapsulation, which may impede regeneration. An undamaged tissue matrix elicits a minimal inflammatory response because it retains the structure and function of the tissue to support regeneration.6-8*

Take a closer look at AlloDermTM RTM
Through the preservation of an intact matrix, AlloDermTM RTM elicited a minimal inflammatory response and no evidence of scar tissue formation in a preclinical model, as confirmed via the limited presence of macrophages and absence of foreign-body giant cells. The minimal inflammation contributes to the rapid and complete restoration of tissue during healing. Damaged tissue matrices elicit chronic inflammatory response demonstrated by foreign-body giant cells (noted by small circles) and hypercellular mixed inflammatory infiltrate (noted by dashed circle).11-14,18*

Minimal inflammatory
response

All samples are from 1-month implantation in NHP models in 5 different studies. AlloDermTM RTM, AlloMax®, Flex HD®, and SurgiMend® samples are from 1-month implantation in NHP-AWR models. DermACELL® sample is from 1 month in NHP subcutaneous model. Each image is shown stained with Hematoxylin & Eosin (H&E) at 200x magnification. H&E stains collagen fibers pink and cell nuclei blue-purple. Nuclei of lymphocytes are round, fibroblasts are elongated, and macrophages are round and diffuse. *Correlation of these results, based on animal studies, to results in humans has not been established.

The negative effects of chronic inflammation

Prevents
remodeling

Prevents
remodeling

The body perceives a damaged tissue matrix as foreign, which may cause inflammation that impedes regeneration.6,7*

Provokes scar
formation

Provokes scar formation

Chronic inflammation often results in the formation of scar tissue. As inflammation increases, the rate of scar tissue formation is exacerbated.19,20*

Inhibits the ability
to fight infection

Inhibits the ability
to fight infection

Chronic inflammation may delay revascularization, which may impede fibroblast integration, blood vessel formation, and the ability to fight infection.21,22

Lack of scar formation

Positive recognition of AlloDermTM RTM supports a regenerative
rather than fibrotic response, as shown in preclinical models The body will recognize materials differently and respond in one of two different ways: positive recognition or negative recognition. Excessive or prolonged inflammation from negative recognition often promotes fibrosis. The fibrotic process is the opposite of functional tissue regeneration. Positive outcomes are most often associated with minimized inflammatory response.7,11,20*

Wound healing cascade

Weak

Weak

Scar tissue has suboptimal functional, biomechanical, and physiological characteristics. It is weaker than normal fascia.19,20,23

Contractile

Contractile

A damaged tissue matrix is more likely to result in greater levels of scar and subsequent contracture. In a primate model, AlloDerm™ RTM demonstrated minimal contraction.8,11*

Causes visual deformities

Causes visual deformities

Graft contraction can cause a visual deformity (loss of domain) and reduce function and mobility of the tissue.19

*Correlation of these results, based on animal studies, to results in humans has not been established.

Lack of resorption

AlloDermTM RTM did not demonstrate resorption of the graft in a primate model

Take a closer look at AlloDermTM RTM

An undamaged tissue matrix retains the structural and biomechanical properties that allow for positive recognition, supporting regeneration. Damaged matrices have altered structure and therefore are viewed by the body as foreign, which leads to contraction and resorption of the graft.5-8*

AlloDerm™ RTM showed minimal change in size 1 month after implantation in a primate model, demonstrating a lack of resorption and minimal contracture of surrounding tissue.11*

Baseline at time of placement
3 cm x 7 cm11,12,14

9.4% ± 14.3%

48.0% ± 8.9%

34.1% ± 18.3%

Representative gross photographs of tissue matrices evaluated following 1-month implantation in NHP-AWR model. Samples are taken from 3 different studies that followed the same protocol and were performed at the same institution at different times. All tissue matrices were fixated to the edges of a 3 x 7 cm full-thickness defect in the abdominal wall of nonhuman primates in an interpositional bridging configuration. *Correlation of these results, based on animal studies, to results in humans has not been established.

Consequences of resorption

Loss of strength

Loss of strength

Damaged ADMs demonstrated a loss of graft strength due to resorption.8,24

Loss of support

Loss of support

Damaged ADMs have demonstrated decreased biomechanical healing strength and diminished graft integrity.24

Replaced
with scar

Replaced with scar

A damaged tissue matrix may lead to degradation, resulting in partial or complete resorption and replacement of collagen matrix fibers with scar tissue.6,8,25

*Correlation of these results, based on animal studies, to results in humans has not been established.

Pliability and handling

AlloDermTM RTM offers desired pliability and handling26

An undamaged tissue matrix retains elastin, which functions in close association with collagen to provide elasticity and shape retention. AlloDermTM RTM revealed widespread evidence of elastin in out-of-package staining.6,7,27

Take a closer look at AlloDermTM RTM

Out-of-package Verhoeff Van Gieson staining for elastin, 100x. Elastin stains black.

The maintenance of graft integrity in AlloDermTM RTM, including intact collagen fibers and elastin microfibrils, allows for surgeon-preferred handling and pliability. AlloDermTM RTM provides appropriate mechanical properties, including tensile strength and elasticity, both out-of-package as well as following implantation.5-7,26*

*Correlation of these results, based on animal studies, to results in humans has not been established.

AlloDermTM RTM demonstrated pliability and drapeability out-of-package28

Importance of pliability

Conforms to defect

Conforms to defect

An undamaged tissue matrix retains characteristics of native tissue and is pliable and able to conform to a defect.5,29

Tissue apposition

Tissue apposition

Tissue needs to conform to defect to have appropriate apposition to the vascular surface to revascularize.30

Better handling

Ideal handling

Tissue processed using certain damaging reagents can affect tissue characteristics and collagen structure.5,9

References: 1. Wainwright DJ. Use of an acellular allograft dermal matrix (AlloDerm) in the management of full-thickness burns. Burns. 1995;21(4):243-248. 2. Data on file, Allergan Aesthetics; Search Performed on PubMed in August 2021. 3. Data on file, Allergan Aesthetics, 2021; Number of AlloDermTM RTM Units Sold. 4. Data on file, Allergan Aesthetics, December 2021; Plastic Surgery Aesthetic Monthly Tracker. 5. Data on file, Allergan; Study Report LRD2016-08-014. 6. Xu H, Wan H, Sandor M, et al. Host response to human acellular dermal matrix transplantation in a primate model of abdominal wall repair. Tissue Eng Part A. 2008;14(12):2009-2019. 7. Harper JR, McQuillan DJ. Extracellular wound matrices: a novel regenerative tissue matrix (RTM) technology for connective tissue reconstruction. Wounds. 2007;19(6):163-168. 8. Sandor M, Xu H, Connor J, et al. Host response to implanted porcine-derived biologic materials in a primate model of abdominal wall repair. Tissue Eng Part A. 2008;14(12):2021-2031.9. AlloDerm SELECTTM and AlloDerm SELECT RESTORETM Regenerative Tissue Matrix Instructions for Use, March 2020. 10. Data on file, Allergan; Study Report LRD2005-08-003. 11. Data on file, Allergan; Study Report LRD2010-04-005. 12. Data on file, Allergan; Study Report LRD2006-02-004. 13. Data on file, Allergan; Study Report LRD2015-04-005. 14. Data on file, Allergan; Study Report LRD2006-10-012. 15. Orenstein SB, Qiao Y, Kaur M, Klueh U, Kreutzer DL, Novitsky YW. Human monocyte activation by biologic and biodegradable meshes in vitro. Surg Endosc. 2010;24(4):805-811. 16. Holton LH III, Chung T, Silverman P, et al. Comparison of acellular dermal matrix and synthetic mesh for lateral chest wall reconstruction in a rabbit model. Plast Reconstr Surg. 2007;119(4):1238-1246. 17. Rademakers T, Horvath JM, van Blitterswijk CA, LaPointe VLS. Oxygen and nutrient delivery in tissue engineering: approaches to graft revascularization. J Tissue Eng Regen Med. 2019;13(10):1815-1829. 18. Delgado LM, Bayon Y, Pandit A, Zeugolis DI. To cross-link or not to cross-link? Cross-linking associated foreign body response of collagen-based devices. Tissue Eng Part B Rev. 2015;21(3):298-313. 19. Xue M, Jackson CJ. Extracellular matrix reorganization during wound healing and its impact on abnormal scarring. Adv Wound Care (New Rochelle). 2015;4(3):119-136. 20. Keane TJ, Horejs CM, Stevens MM. Scarring vs. functional healing: matrix-based strategies to regulate tissue repair. Adv Drug Deliv Rev. 2018; 129:407-419. 21. Buchanan E, Yoo D. Use of biologic extracellular matrix in two ways to reduce cardiac electronic device infection. Cureus. 2021;13(1): e13037. doi:10.7759/cureus.13037 22. Bellows CF, Alder A, Helton WS. Abdominal wall reconstruction using biological tissue grafts: present status and future opportunities. Expert Rev Med Devices. 2006;3(5):657-675. 23. Holinsky C, Sandberg S. Measurement of the tensile strength of the ventral abdominal wall in comparison with scar tissue. Clin Biomech (Bristol, Avon). 2007;22(1):88-92. 24. Sun WQ; Xu H, Sandor M, Lombardi J. Process-induced extracellular matrix alterations affect the mechanisms of soft tissue repair and regeneration. J Tissue Eng. 2013. doi:10.1177/2041731413505305 25. Data on file, Allergan; Study Report LRD2010-05-002. 26. Data on file, Allergan Aesthetics, June 2021; ADM/AlloDerm Perception (AU). 27. Frantz C, Steward KM, Weaver VM. The extracellular matrix at a glance. J Cell Sci. 2010;123(pt 24):4195-4200. 28. Data on file, Allergan; Study Report LRD2017-06-009. 29. Sherris DA, Oriel BS. Human acellular dermal matrix grafts for rhinoplasty. Aesthetic Surg J. 2011;31(suppl 7):95S-100S. 30. Khansa I, Janis JE. Modern reconstructive techniques for abdominal wall defects after oncologic resection. J Surg Oncol. 2015;111(5):587-598.
ALLODERM SELECTTM REGENERATIVE TISSUE MATRIX INDICATIONS AND IMPORTANT SAFETY INFORMATION  

ALLODERM SELECTTM REGENERATIVE TISSUE MATRIX
INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

ALLODERM SELECTTM Regenerative Tissue Matrix (ALLODERM SELECTTM RTM refers to both ALLODERM SELECTTM RTM and ALLODERM SELECT RESTORETM RTM products) is intended to be used for repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. This product is intended for single patient one-time use only. ALLODERM SELECTTM RTM is not indicated for use as a dural substitute or intended for use in veterinary applications.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ALLODERM SELECTTM RTM should not be used in patients with a known sensitivity to any of the antibiotics listed on the package and/or Polysorbate 20.

WARNINGS

Processing of the tissue, laboratory testing, and careful donor screening minimize the risk of the donor tissue transmitting disease to the recipient patient. As with any processed donor tissue, ALLODERM SELECTTM RTM is not guaranteed to be free of all pathogens. No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential or reproductive impact of the clinical application of ALLODERM SELECTTM RTM.

DO NOT re-sterilize ALLODERM SELECTTM RTM. DO NOT reuse once the tissue graft has been removed from the packaging and/or is in contact with a patient. Discard all open and unused portions of the product in accordance with standard medical practice and institutional protocols for disposal of human tissue. Once a package or container seal has been compromised, the tissue shall be either transplanted, if appropriate, or otherwise discarded. DO NOT use if the foil pouch is opened or damaged. DO NOT use if the seal is broken or compromised. DO NOT use if the temperature monitoring device does not display “OK.” DO NOT use after the expiration date noted on the label. Transfer ALLODERM SELECTTM RTM from the foil pouch aseptically. DO NOT place the foil pouch in the sterile field.

PRECAUTIONS

Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for implanting ALLODERM SELECTTM RTM as such conditions may compromise successful clinical outcome. Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.

ALLODERM SELECTTM RTM has a distinct basement membrane (upper) and dermal surface (lower). When applied as an implant, it is recommended that the dermal side be placed against the most vascular tissue. Soak the tissue for a minimum of 2 minutes using a sterile basin and room temperature sterile saline or room temperature sterile lactated Ringer’s solution to cover the tissue. If any hair is visible, remove using aseptic technique before implantation.

ALLODERM SELECTTM RTM should be hydrated and moist when the package is opened. DO NOT use if this product is dry. Use of this product is limited to specific health professionals (e.g., physicians, dentists, and/or podiatrists). Certain considerations should be made to reduce the risk of adverse events when performing surgical procedures using a tissue graft. Please see the Instructions for Use (IFU) for more information on patient/product selection and surgical procedures involving tissue implantation before using ALLODERM SELECTTM RTM.

ADVERSE EVENTS

The most commonly reported adverse events associated with the implant of a tissue graft include, but are not limited to the following: wound or systemic infection; seroma; dehiscence; hypersensitive, allergic or other immune response; and sloughing or failure of the graft.

ALLODERM SELECTTM RTM is available by prescription only.

For more information, please see the Instructions for Use (IFU) for ALLODERM SELECTTM RTM available at www.allergan.com/AlloDermIFU or call 1.800.678.1605.

To report an adverse reaction, please call Allergan at 1.800.433.8871.

ALLODERM SELECTTM Regenerative Tissue Matrix Indications and  Important Safety Information 

ALLODERM SELECTTM Regenerative Tissue Matrix
Indications and Important Safety Information

INDICATIONS

ALLODERM SELECTTM Regenerative Tissue Matrix (ALLODERM SELECTTM RTM refers to both ALLODERM SELECTTM RTM and ALLODERM SELECT RESTORETM RTM products) is intended to be used for repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. This product is intended for single patient one-time use only. ALLODERM SELECTTM RTM is not indicated for use as a dural substitute or intended for use in veterinary applications.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ALLODERM SELECTTM RTM should not be used in patients with a known sensitivity to any of the antibiotics listed on the package and/or Polysorbate 20.

WARNINGS

Processing of the tissue, laboratory testing, and careful donor screening minimize the risk of the donor tissue transmitting disease to the recipient patient. As with any processed donor tissue, ALLODERM SELECTTM RTM is not guaranteed to be free of all pathogens. No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential or reproductive impact of the clinical application of ALLODERM SELECTTM RTM.

DO NOT re-sterilize ALLODERM SELECTTM RTM. DO NOT reuse once the tissue graft has been removed from the packaging and/or is in contact with a patient. Discard all open and unused portions of the product in accordance with standard medical practice and institutional protocols for disposal of human tissue. Once a package or container seal has been compromised, the tissue shall be either transplanted, if appropriate, or otherwise discarded. DO NOT use if the foil pouch is opened or damaged. DO NOT use if the seal is broken or compromised. DO NOT use if the temperature monitoring device does not display “OK.” DO NOT use after the expiration date noted on the label. Transfer ALLODERM SELECTTM RTM from the foil pouch aseptically. DO NOT place the foil pouch in the sterile field.

PRECAUTIONS

Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for implanting ALLODERM SELECTTM RTM as such conditions may compromise successful clinical outcome. Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.

ALLODERM SELECTTM RTM has a distinct basement membrane (upper) and dermal surface (lower). When applied as an implant, it is recommended that the dermal side be placed against the most vascular tissue. Soak the tissue for a minimum of 2 minutes using a sterile basin and room temperature sterile saline or room temperature sterile lactated Ringer’s solution to cover the tissue. If any hair is visible, remove using aseptic technique before implantation.

ALLODERM SELECTTM RTM should be hydrated and moist when the package is opened. DO NOT use if this product is dry. Use of this product is limited to specific health professionals (e.g., physicians, dentists, and/or podiatrists). Certain considerations should be made to reduce the risk of adverse events when performing surgical procedures using a tissue graft. Please see the Instructions for Use (IFU) for more information on patient/product selection and surgical procedures involving tissue implantation before using ALLODERM SELECTTM RTM.

ADVERSE EVENTS

The most commonly reported adverse events associated with the implant of a tissue graft include, but are not limited to the following: wound or systemic infection; seroma; dehiscence; hypersensitive, allergic or other immune response; and sloughing or failure of the graft.

ALLODERM SELECTTM RTM is available by prescription only.

For more information, please see the Instructions for Use (IFU) for ALLODERM SELECTTM RTM.

To report an adverse reaction, please call Allergan at 1.800.433.8871.