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Positive biological response2,*
Consistency in thickness uniformity3,†,*
Consistency in stretch of a porcine acellular dermal matrix (PADM)4,†,*
Designed to have similar drapability to AlloDermTM RTM, a human ADM (HADM)5,*
ADM = acellular dermal matrix; RTM = reconstructive tissue matrix.
*Correlation of these results to results in humans has not been established.
†Clinical significance is unknown.
Our Processing Maintains an Intact Tissue Matrix to Support Positive Recognition
Our proprietary LifeCell Tissue Processing is designed to preserve the structure and strength of the matrix, reduce inflammatory response, and support regeneration.
ARTIA™ demonstrated a similar histological microstructure to both
human dermis and AlloDerm™ RTM after processing.7
Ultrastructural out-of-package morphology of surgical scaffolds as compared with native human dermis (1000x scanning electron micrographs). Hematoxylin and Eosin (H&E) staining at 100x magnification.
Not All ADMs Are the Same — Regeneration Is Key
Harnessing the body’s natural processes is essential to restoring and maintaining the structure, function, and physiology of tissue. Upon tissue injury, the body will begin the repair or regeneration process, based on its recognition of the material used. An intact extracellular tissue matrix contains the ideal scaffold, with critical cellular and biochemical components to support the regenerative process.8,9
An ADM is recognized either positively or negatively*
*Correlation of these results to results in humans has not been established.
ARTIATM Demonstrated a Positive Biologic Response
Rapid revascularization, cellular repopulation, and minimal inflammatory response were shown in a primate model.2 Harnessing over 30 years of experience in tissue processing, the steps to remove antigens in xenografts have been developed for ARTIA™, resulting in a positive biologic response.2,6,*
*Correlation of these results to results in humans has not been established.
ARTIATM Offers an Extensive Portfolio That Aligns With Your Clinical Needs
Consistency in thickness uniformity6
ARTIA™ is derived from a controlled source material and demonstrates minimal piece-to-piece variability.*
An average thickness of 1.49 mm with a standard deviation of 0.23 mm
*Clinical significance is unknown.
ARTIATM Demonstrates Consistency in Stretch*
ARTIATM RTM delivers consistency and stretch between AlloDermTM RTM (HADM) and STRATTICETM Pliable (PADM).4
Loads represented are per 2-cm-width samples, and the error bars represent one standard deviation (SD) from the mean.4
*Clinical significance is unknown.
ARTIATM Provides Desirable Pliability
ARTIATM is designed to have similar handling and drapability to AlloDermTM 5,*
*Clinical significance is unknown.
ARTIATM—Backed by the Market Leaders in ADM
The ARTIATM RTM Guarantee Program offers facility customers a replacement of any piece of ARTIATM that is explanted, subject to the program terms and conditions.
To be eligible for the guarantee, facilities must comply with all terms and conditions. For more information, contact your local Allergan Aesthetics representative today, or call Allergan Aesthetics Customer Service at 1.800.367.5737.
Terms and Conditions
The ARTIATM Guarantee Program applies to all pieces of ARTIATM RTM that are explanted, provided that the product has been used:
- As intended by appropriately qualified and licensed surgeons
- In accordance with the current ARTIATM RTM Instructions for Use, found at https://www.rxabbvie.com/pdf/ARTIA_ifu.pdf
All ARTIATM RTM replacement requests are subject to the Allergan Aesthetics review process. The ARTIATM Guarantee Program is available to all facility customers. No separate contract is required to take advantage of the program. If a facility receives a replacement piece of ARTIATM RTM at no charge from Allergan Aesthetics, the facility will not seek reimbursement for the product from the patient or any government or private healthcare plans.
For more information,
contact an Allergan Aesthetics Sales Representative
References: 1. Allergan Inc. ArtiaTM Reconstructive Tissue Matrix Instructions for Use, 2018. 2. Data on file, Allergan; Study Report LRD-2014-01-002. 3. Data on file, Allergan; Study Report LRD-2017-06-009. 4. Data on file, Allergan; Study Report LRD-2015-12-002. 5. Data on file, Allergan; Study Report LRD-2016-08-005. 6. LifeCell Corporation (1994, August 3). LifeCell Corporation reports second quarter results: announces formation of AlloDerm® advisory board. [Press release]. 7. Data on file, Allergan; Study Report LRD-2016-02-011. 8. Harper JR, McQuillan DJ. Extracellular wound matrices: a novel regenerative tissue matrix (RTM) technology for connective tissue reconstruction. Wounds. 2007;19(6):163-168. 9. 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. 10. 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.
ARTIA™ Reconstructive Tissue Matrix Indications and Important Safety Information
INDICATIONS
ARTIA™ Reconstructive Tissue Matrix (ARTIA™ RTM) is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissue in plastic and reconstructive surgery. ARTIA™ RTM is supplied sterile and is intended for single patient, one time use only.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
This product should not be used in patients with a known sensitivity to porcine material and/or Polysorbate 20.
WARNINGS
Do not resterilize. Discard all open and unused portions of this device. Do not use if the package is opened or damaged. Do not use if seal is broken or compromised. Do not use if the temperature monitoring device does not display “OK.” After use, handle and dispose of all unused product and packaging in accordance with accepted medical practice and applicable local, state, and federal laws and regulations. ARTIA™ Tissue Matrix cannot be reused once it has been removed from the packaging and/or is in contact with a patient without increased risk of patient-to-patient contamination and subsequent infection. The user should be aware of high recurrence rates when using a surgical mesh for bridging repair in load-bearing applications (eg, hernia repair).
PRECAUTIONS
Use of the product in breast reconstruction has not been studied in a prospective clinical trial.
Discard product if handling has caused possible damage or contamination, or the product is past the expiration date. Ensure the surgical mesh is soaked in room temperature sterile saline or room temperature sterile lactated Ringer’s solution for a minimum of 2 minutes prior to implantation in the body. Place the product in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling. The surgical mesh should be hydrated and moist when the package is opened. If the product is dry, do not use. If a tissue punch-out piece is visible, remove using aseptic technique before implantation.
Certain considerations should be used when performing surgical procedures using a surgical mesh product. Consider the risk/benefit balance of use in patients with significant co-morbidities; including but not limited to, obesity, smoking, diabetes, immunosuppression, malnourishment, poor tissue oxygenation (such as COPD), and pre- or post-operative radiation.
Bioburden-reducing techniques should be utilized in significantly contaminated or infected cases to minimize contamination levels at the surgical site, including, but not limited to, appropriate drainage, debridement, negative pressure therapy, and/or antimicrobial therapy prior and in addition to implantation of the surgical mesh.
ARTIA™ RTM is available by prescription only.
For more information, please see the Instructions for Use (IFU) for ARTIA™ RTM.
For product complaints and potential adverse events, please contact your local Sales Representative, or 1.800.433.8871.
ALLODERM SELECT™ Regenerative Tissue Matrix Indications and Important Safety Information
INDICATIONS
ALLODERM SELECT™ Regenerative Tissue Matrix (ALLODERM SELECT™ RTM refers to both ALLODERM SELECT™ RTM and ALLODERM SELECT RESTORE™ 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 SELECT™ RTM is not indicated for use as a dural substitute or intended for use in veterinary applications.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
ALLODERM SELECT™ 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 SELECT™ 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 SELECT™ RTM.
DO NOT re-sterilize ALLODERM SELECT™ 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 SELECT™ 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 SELECT™ 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 SELECT™ 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 SELECT™ 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 SELECT™ 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 SELECT™ RTM is available by prescription only.
For more information, please see the Instructions for Use (IFU) for ALLODERM SELECT™ RTM.
To report an adverse reaction, please call Allergan at 1.800.433.8871.
STRATTICE™ Reconstructive Tissue Matrix (RTM) Indications and Important Safety Information
INDICATIONS
STRATTICE™ Reconstructive Tissue Matrix (RTM), STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick, and STRATTICE™ RTM Laparoscopic are intended for use as soft tissue patches to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use of these products include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. STRATTICE™ RTM Laparoscopic is indicated for such uses in open or laparoscopic procedures. These products are supplied sterile and are intended for single patient one-time use only.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
These products should not be used in patients with a known sensitivity to porcine material and/or Polysorbate 20.
WARNINGS
- Do not resterilize. Discard all open and unused portions of these devices. Do not use if the package is opened or damaged. Do not use if seal is broken or compromised. After use, handle and dispose of all unused product and packaging in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.
- Do not reuse once the surgical mesh has been removed from the packaging and/or is in contact with a patient. This increases risk of patient-to-patient contamination and subsequent infection.
- For STRATTICE™ RTM Extra Thick, do not use if the temperature monitoring device does not display “OK.”
PRECAUTIONS
Discard these products if mishandling has caused possible damage or contamination, or the products are past their expiration date. Ensure these products are placed in a sterile basin and covered with room temperature sterile saline or room temperature sterile lactated Ringer’s solution for a minimum of 2 minutes prior to implantation in the body. Place these products in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling. These products should be hydrated and moist when the package is opened. If the surgical mesh is dry, do not use.
Certain considerations should be used when performing surgical procedures using a surgical mesh product. Consider the risk/benefit balance of use in patients with significant co-morbidities; including but not limited to, obesity, smoking, diabetes, immunosuppression, malnourishment, poor tissue oxygenation (such as COPD), and pre- or post-operative radiation. Bioburden-reducing techniques should be utilized in significantly contaminated or infected cases to minimize contamination levels at the surgical site, including, but not limited to, appropriate drainage, debridement, negative pressure therapy, and/or antimicrobial therapy prior and in addition to implantation of the surgical mesh. In large abdominal wall defect cases where midline fascial closure cannot be obtained, with or without separation of components techniques, utilization of the surgical mesh in a bridged fashion is associated with a higher risk of hernia recurrence than when used to reinforce fascial closure.
For STRATTICE™ RTM Perforated, if a tissue punch-out piece is visible, remove using aseptic technique before implantation.
For STRATTICE™ RTM Laparoscopic, refrain from using excessive force if inserting the mesh through the trocar.
STRATTICE™ RTM, STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick, and STRATTICE™ RTM Laparoscopic are available by prescription only.
For more information, please see the Instructions for Use (IFU) for all STRATTICE™ RTM products.
To report an adverse reaction, please call Allergan at 1.800.367.5737.