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ABS-4400

Orthobiologics

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Arthrex Amnion matrix is rich in growth factors and contains regenerative qualities that maintain the natural healing properties of amnion. Used as an anatomical barrier or wrap in a variety of orthopedic applications. Arthrex Amnion provides essential biological and mechanical protection while helping to prevent adhesion.1
Reference
1. Kim SS, Sohn SK, Lee KY, Lee MJ, Roh MS, Kim CH. Use of human amniotic membrane wrap in reducing perineural adhesions in a rabbit model of ulnar nerve neurorrhaphy. J Hand Surg Eur Vol. 2010;35(3):214-219. doi:10.1177/1753193409352410

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Arthrex Amnion™ Matrix Natural Mechanical Protection Introducing Arthrex Amnion™ Matrix Arthrex Amnion grafts maintain the natural mechanical properties of amnion and are rich in key growth factors and cytokines. Arthrex Amnion grafts provide an anatomic barrier that aids in providing mechanical protection and support to soft tissue. 02 I Arthrex Amnion Matrix Arthrex Amnion™ Matrix Arthrex Amnion Matrix Features and Benefits Amniotic-derived tissues contain endogenous growth factors and cytokines1-4 that maintain the natural properties of amnion. Arthrex Amnion matrix is an anatomical barrier that helps provide mechanical protection5 while supporting tissue with nutrient-rich growth factors.6-8 Amnion Membrane Epithelium Basement Membrane Compact Layer Fibroblast Layer About Amnion: Intermediate (Spongy) Layer Amniotic membrane is a thin, semitransparent and resilient membrane that lines the inner cavity of the placenta. Reticular Layer Basement Membrane With over 100 years of clinical history, the functional capability of amniotic membrane is well documented. 3 Trophoblasts Just as amniotic tissue protects and cushions the fetus during development, Arthrex Amnion matrix helps provide the same support to damaged tissue.4 Epithelium Basement Membrane Arthrex Amnion matrix harnesses growth factors essential for signaling.4,7 Stromal Layer The natural properties of Arthrex Amnion matrix are preserved during processing, maintaining inherent levels of key extracellular matrix proteins, growth factors, and cytokines.6,9 Growth Factors Released From Arthrex Amnion Matrix After 24 Hours at 37°C 1911 3000 2500 1500 332 1000 HGF TIMP-3 IGF-1 TGF-ß2 bFGF 1 12 26 IL-6 32 EGF 54 49 53 60 IGF-2 TGF-ß1 PDGF-BB GRO- TIMP-4 IL-1RA alpha 15 TIMP-2 45 0 97 98 500 90 251 pg GF/cm2 1213 2000 MCP-1 TGF-a TNF-a Arthrex Amnion Matrix I 03 Arthrex Amnion™ Matrix Surgical applications In general orthopedics, arthroplasty, hand and wrist, and foot and ankle procedures, Arthrex Amnion matrix has been used as a protective barrier to provide essential mechanical protection.5,10 Shoulder Hand and Wrist Knee Tendons Achilles Nerves Wounds Nerve Wrap Arthrex amnion matrix can be used as an anatomical wrap to act as a natural structural barrier.5 Rotator Cuff Repair Achilles Repair Anterior Cruciate Ligament (ACL) Repair Growth Factors Present in Amniotic Tissue and Corresponding Function11 Growth Factor and Cytokines Abbreviation Property/Function Hepatocyte Growth Factor HGF Myogenesis, Wound Healing, Organ Regeneration Epidermal Growth Factor EGF Cell Growth, Proliferation, Differentiation Tumor Necrosis Factor-α TNF-α Apoptosis, Angiogenesis Chemokine GRO-α Angiogenesis, Wound Healing Monocyte Chemoattractant Protein-1 MCP-1 Immune Modulation Tissue Inhibitor of Metalloproteinases (1,2,3,4) TIMP (1,2,3,4) Growth Promotion Insulin-Like Growth Factor (1,2) IGF (1,2) Cell Activation, Platelet Degranulation IL1-Receptor Antagonist IL1-RA Anti-inflammatory Transforming Growth Factor (α, β1, β2) TGF (α, β1, β2) Proliferation, Differentiation, Immune Modulation 04 I Arthrex Amnion Matrix Arthrex Amnion™ Matrix Arthrex Amnion matrix is available in two convenient forms Arthrex Amnion thin matrix is derived from the amnion membrane layer of the placenta. This semitransparent tissue can be applied directly to the surgical site for use in a number of different soft-tissue applications. Arthrex Amnion cord matrix is a thicker membrane derived from the umbilical cord. This resilient graft is thick enough to hold a stitch when hydrated. These immune-privileged tissues are prepared with a processing methodology that is able to preserve the natural architecture of the amniotic membrane and its functional capability.6 (a) Arthrex Amnion matrix is available in a variety of thin and thick membranes ideal for orthopedic applications. It is indicated for homologous use as a soft-tissue covering, barrier or wound covering.7 Arthrex Amnion Matrix Ordering Information Product Description Item Number Arthrex Amnion Matrix - Thin (a) 2 cm × 2 cm ABS-4100-022 2 cm × 3 cm ABS-4100-023 3 cm × 3 cm ABS-4100-033 4 cm × 4 cm ABS-4100-044 4 cm × 6 cm ABS-4100-046 4 cm × 8 cm ABS-4100-048 7 cm × 7 cm ABS-4100-077 2 cm × 12 cm ABS-4100-212 (b) Arthrex Amnion Matrix - Cord (b) 2 cm × 2 cm ABS-4200-022 2 cm × 3 cm ABS-4200-023 3 cm × 3 cm ABS-4200-033 3 cm × 4 cm ABS-4200-034 3 cm × 6 cm ABS-4200-036 3 cm × 8 cm ABS-4200-038 Arthrex Amnion Matrix I 05 AmnionXpress™ Delivery Device For the insertion of an Arthrex Amnion 5 mm × 40 mm streamer to damaged pathologic tissue in the shoulder The AmnionXpress delivery device is designed to allow the simple loading of Arthrex Amnion matrix strips made from umbilical cord membrane and measuring 40 mm × 5 mm through a slot that is captured and advanced by a forked-tip nitinol delivery needle. The AmnionXpress delivery device is used for precise insertion of an amniotic matrix strip directly to the pathologic tissues. The inherent properties of amniotic tissues help provide an anatomic barrier to aid in providing mechanical protection, while proprietary processing retains nutrient-rich growth factors essential for signaling.1,12 AmnionXpress device prior to loading, and then with the forked-tip Nitinol needle fully deployed. Arthrex AmnionXpress Ordering Information Product Description Item Number AmnionXpress Delivery Device ABS-4400 Amnion Matrix, Cord Membrane, 5 mm × 40 mm ABS-4200-054 06 I Arthrex Amnion Matrix AmnionXpress delivery device References 1. Coolen NA, Schouten KC, Middelkoop E, Ulrich MM. Comparison between human fetal and adult skin. Arch Dermatol Res. 2010;302(1):47-55. doi:10.1007/s00403009-0989-8 2. Coolen NA, Schouten KC, Boekema BK, Middelkoop E, Ulrich MM. Wound healing in a fetal, adult, and scar tissue model: a comparative study. Wound Repair Regen 2010;18(3):291-301. doi:10.1111/j.1524-475X.2010.00585.x 3. Tseng SC, Espana EM, Kawakita T, et al. How does amniotic membrane work? Ocul Surf. 2004;2(3):177-187 4. Riordan NH, George BA, Chandler TB, McKenna RW. Case report of non-healing surgical wound treated with dehydrated human amniotic membrane. J Transl Med. 2015;13:242. doi:10.1186/s12967-015-0608-8 5. Kim SS, Sohn SK, Lee KY, et al. Use of human amniotic membrane wrap in reducing perineural adhesions in a rabbit model of ulnar nerve neurorrhaphy. J Hand Surg Eur Vol. 2010;35(3):214-219. doi:10.1177/1753193409352410 6. Delcroix GJ, Namin S, D’Ippolito G, Temple HT, Marshall R. Preserving the natural egenerative potential of amniotic membrane. Vivex Biomedical 7. Niknejad H, Peirovi H, Jorjani M, et al. Properties of the amniotic membrane for potential use in tissue engineering. Eur Cell Mater. 2008;15:88-89 8. Koob TJ, Lim JJ, Massee M, Zabek N, Denoizièr G. Properties of dehydrated human amnion/chorion composite grafts: implications for wound repair and soft tissue regeneration. J Biomed Mater Res B Appl Biomater. 2014;102(6):1353-1362. doi:10.1002/jbm.b.33141 9. Arthrex Amnion™ Matrix Thin and Cord [Instructions for Use (80-166 02)]. Naples, FL: Arthrex, Inc. 2016 10. Jerabek SA, Carroll KM, Michaels B, Mayman DJ. A pilot study to evaluate the safety and efficacy of amniotic membrane transplantation in patients with arthrofibrosis following total knee arthroplasty. Hospital for Special Surgery. http://www.amniomedical.com/wp-content/uploads/Amniotic_Hip_Knee_Study. pdf. Accessed November 21, 2017 11. Hui AY, McCarty WJ, Masuda K, Firestein GS, Sah RL. A systems biology approach to synovial joint lubrication in health, injury, and disease. Wiley Interdisc Rev Syst Biol Med. 2012;4(1):15–37. doi:10.1002/wsbm.157 12. Rowlatt U. Intrauterine would healing in a 20 week human fetus. Virchows Arch A Pathol Anat Histol. 1979;381(3):353-361. doi:10.1007/BF00432477 References I 07 This description of technique is provided as an educational tool and clinical aid to assist properly licensed medical professionals in the usage of specific Arthrex products. As part of this professional usage, the medical professional must use their professional judgment in making any final determinations in product usage and technique. In doing so, the medical professional should rely on their own training and experience, and should conduct a thorough review of pertinent medical literature and the product’s directions for use. Postoperative management is patient-specific and dependent on the treating professional’s assessment. Individual results will vary and not all patients will experience the same postoperative activity level and/or outcomes. View U.S. patent information at www.arthrex.com/corporate/virtual-patent-marking arthrex.com © 2021 Arthrex, Inc. All rights reserved. LB1-00120-EN_C

Arthrex Amnion™ Matrix

AmnionXpress™ Delivery Device Surgical Technique AmnionXpress™ Delivery Device For the insertion of an Arthrex Amnion™ 5 mm × 40 mm streamer to damaged pathologic tissue in the shoulder The AmnionXpress delivery device is used for precise insertion of an amniotic matrix strip directly to the pathologic tissues. The inherent properties of amniotic tissues help provide an anatomic barrier to aid in providing mechanical protection, while proprietary processing retains nutrient-rich growth factors essential for signaling.¹,² The feel of the device will be familiar to arthroscopic surgeons, as it is similar to the SutureLasso™ suture passers. AmnionXpress delivery device before loading and with the forked-tip nitinol needle fully deployed. The AmnionXpress delivery device is designed to allow the simple loading of Arthrex Amnion matrix strips made from umbilical cord membrane and measuring 40 mm × 5 mm through a slot that is captured and advanced by a forked-tip nitinol delivery needle. AmnionXpress delivery device AmnionXpress Delivery Device Surgical Technique 3 1 Use preoperative MRI and/or intraoperative assessment to identify the pathologic area to be treated. 02 I AmnionXpress Delivery Device AmnionXpress™ Delivery Device Surgical Technique (Cont.) 1 2 Once the pathologic area is identified, determine the appropriate path and depth insertion of the AmnionXpress delivery device to the damaged rotator cuff. This is done by first localizing a “straight shot” using a localizing spinal needle percutaneously. 4 Advance the thumb slide plunger to the first metal ball stop. There is a palpable stop here that corresponds to the point where the fork-tipped nitinol delivery needle stops just short of the window. 3 Once the path is established with the spinal needle, make a small skin incision just large enough to accommodate a switching stick. If desired, a switching stick can be used to dilate a course through the deltoid/soft tissues. 5 While the amnion streamer is dry, insert one end half way through the window in the metal shaft of the AmnionXpress delivery device. AmnionXpress Delivery Device I 03 AmnionXpress™ Delivery Device Surgical Technique (Cont.) 1 6 Wet the streamer lightly. It will become quite pliable and ready for loading. 7 2 Advance the thumb slide plunger evenly to the second stop. The forked-tip nitinol needle can be seen traversing the window and snaring the central portion of the amnion streamer, advancing it further into the AmnionXpress delivery device. 8 Place the AmnionXpress delivery device into the subacromial space along the line that the spinal needle took to ensure that a “straight shot” can be achieved into the pathology. The AmnionXpress delivery device can be placed on top of the damaged cuff to visualize the line and the measured depth of insertion. 04 I AmnionXpress Delivery Device AmnionXpress™ Delivery Device Surgical Technique (Cont.) 9 Once the AmnionXpress delivery device is applied to the diseased tissue to the appropriate depth, advance the thumb slide plunger of the device all the way to the hard stop, while pulling out the device to 2.5 cm. Complete insertion ensures that the trailing end of the amnion streamer clears the tip of the device. 10 This step demonstrates the fully deployed position of the AmnionXpress delivery device. The position of the forked-tip nitinol needle when the thumb slider is fully advanced corresponds to a distance of 2.5 cm beyond the delivery device. 1 11 Because the amnion streamer has cleared the end of the AmnionXpress device with full deployment, retracting the nitinol needle while holding the delivery device in place ensures that the amnion streamer remains in the precise position in which it was placed. Slowly withdraw the AmnionXpress delivery device. This completes the procedure. AmnionXpress Delivery Device I 05 AmnionXpress™ Delivery Device Surgical Technique (Cont.) 1 12 Completed procedure showing the Arthrex Amnion™ streamer in place. If necessary, repeat the procedure to insert another streamer. Ordering Information Product Description Item Number AmnionXpress™ Delivery Device ABS-4400 Arthrex Amnion™ Matrix, cord membrane, 5 mm × 40 mm ABS-4200-054 References 1. Rowlatt U. Intrauterine wound healing in a 20 week human fetus. Virchows Arch A Pathol Anat Histol. 1979;381(3):353-361. doi:10.1007/BF00432477. 2. Coolen NA, Schouten KC, Middelkoop E, Ulrich MM. Comparison between human fetal and adult skin. Arch Dermatol Res. 2010;302(1):47-55. doi:10.1007/s00403-009-0989-8. 06 I AmnionXpress Delivery Device This description of technique is provided as an educational tool and clinical aid to assist properly licensed medical professionals in the usage of specific Arthrex products. As part of this professional usage, the medical professional must use their professional judgment in making any final determinations in product usage and technique. In doing so, the medical professional should rely on their own training and experience and should conduct a thorough review of pertinent medical literature and the product’s directions for use. Postoperative management is patient-specific and dependent on the treating professional’s assessment. Individual results will vary and not all patients will experience the same postoperative activity level or outcomes. View U.S. patent information at www.arthrex.com/corporate/virtual-patent-marking © 2021 Arthrex, Inc. All rights reserved. | www.arthrex.com | LT1-000057-en-US_B

AmnionXpress™  Delivery Device Surgical Technique

Advanced Wound Care Technology

David Alan Friscia, MD (Rancho Mirage, CA), demonstrates the percutaneous delivery of a strip of Arthrex Amnion™ matrix to the Achilles tendon using the AmnionXpress™ delivery device. This device allows for the precise delivery of an amniotic tissue strip directly to pathologic tissues. The natural properties of amniotic tissues help provide an anatomic barrier to aid in providing mechanical protection, while proprietary processing retains nutrient-rich growth factors essential for signaling.1-3
References:
1. Rowlatt U. Intrauterine wound healing in a 20-week human fetus. Virchows Arch A Pathol Anat Histol. 1979;381(3):353-361.
2. Coolen NA, et al. Comparison between human fetal and adult skin. Arch Dermatol Res. 2010;302(1):47-55.
3. Riboh JC, et al. Human amniotic membrane-derived products in sports medicine: basic science, early results, and potential clinical applications. Am J Sports Med. 2016;44:2425-2434.

video

AmnionXpress™ Percutaneous Delivery of an Amnion Streamer Into the Achilles Tendon

James McWilliam, MD, (New York, NY) demonstrates a technique for a peroneal tendon repair using the Arthrex Amnion™ matrix to provide supplemental support and help protect the repair.

Peroneal Tendon Repair with Arthrex Amnion™ Matrix Augmentation

John M. Tokish, MD (Scottsdale, AZ), demonstrates how to load a 5 mm × 40 mm amnion strip into the AmnionXpress™ delivery device. The AmnionXpress delivery device allows for the precise delivery of an amniotic tissue matrix directly into pathologic tissues. The natural properties of Arthrex Amnion™ matrices help provide an anatomic barrier to aid in providing mechanical protection, while proprietary processing retains nutrient-rich growth factors essential for signaling.

AmnionXpress Delivery Device

ABS-4400

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