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Allogeneic matrix

Allogeneic matrix

Allogeneic matrix

OVERVIEW

Allogeneic Matrices are usually derived from human neonatal fibroblasts of the foreskin that may contain metabolically active or regenerative components primarily used for soft tissue support, though some have been approved for the treatment of full-thickness skin and soft tissue loss. Most are biodegradable and disappear after 3-4 weeks implantation. [1] This category also includes cellular and/or tissue products (also known as skin substitutes) derived from amnion, chorion, placenta or umbilical cord that have not been decellularized. 

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NOTE: This is a controlled document. This document is not a substitute for proper training, experience, and exercising of professional judgment. While every effort has been made to ensure the accuracy of the contents, neither the authors nor the Wound Reference, Inc. give any guarantee as to the accuracy of the information contained in them nor accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omissions in the contents of the work.

REFERENCES

  1. Administrators, CGS et al. Local Coverage Determination (LCD) - Wound Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities (L36690) . 2016;.
Topic 18 Version 1.0

Subtopics

CLINICAL FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/Ps. Among other criteria, HCT/Ps are required to be mini

AlloWrap DS is a human amniotic membrane designed to provide a biologic barrier following surgical repair. See clinical, coding and reimbursement information

CLINICALIndicationsIntended for homologous use as a wound covering.FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of

CLINICALIndicationsFor homologous use as an acute or chronic wound covering FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of com

CLINICALIndicationsAMNIOEXCEL® is intended for use as a wound covering. This product is an allograft tissue intended for homologous use for the repair, reconstruction and replacement of skin at the direction of a physician. FDARegulated under PHS 361

CLINICALIndicationsChronic and acute wounds; diabetic ulcers, venous and arterial ulcers, and pressure ulcersTraumatic injuriesBurnsSurgical wounds

CLINICALIndications Diabetic Ulcers Pressure Ulcers Venous Stasis Ulcers Burns

BioDDryFlex® is a membrane allograft derived from the human placental tissues for use as a tissue barrier. See clinical, coding and reimbursement information.

BioDFence G3 is a multilayer amnion and chorion allograft that covers and protects underlying tissues. See clinical, coding and reimbursement information.

Cygnus is an allogeneic matrix, traditional single layer amnion for topical wounds/burns. See clinical, coding and reimbursement information.

Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure.Dermagraft should be used in conjunction with standard wound care regimens and in patients that have ad

CLINICALIndicationsPartial and full thickness wounds. Diabetic UlcersPressure ulcersTrauma Wounds (abrasions, lacerations, second degree burns, skin tears)Venous UlcersDrainage WoundsChronic Vascular Ulcers Surgical (donor sites/grafts post mohs surgery, post laser surgery, podiatr

CLINICALIndicationsProvides a connective tissue matrix to replace or supplement damaged or inadequate integumental tissue FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue practice, and other procedures to prevent the

CLINICALIndicationsIntended for homologous use in acute and chronic wound care.FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue practice, and other procedures to pre

Excellagen is a flowable allogeneic matrix - a pharmaceutically formulated fibrillar Type I bovine collagen gel for wound care management. See clinical, coding and reimbursement information

E-Z Derm is an allogeneic matrix (porcine xenograft) for wound coverage. See clinical, coding and reimbursement information

CLINICALIndicationsSoft tissue defect fillerSoft tissue traumaTendinitisTendinosisChronic woundsLocalized inflammationJoint painStrains, partial tears (muscles, ligaments, tendons)

FlowerFlo™ Placental Tissue Matrix Allograft is an allogeneic matrix intended to replace or supplement damaged or inadequate integumental tissue.

FlowerPatch™ Amniotic Membrane is a dehydrated amniotic membrane allograft intended to be used as a wound covering. See clinical, coding and reimbursement information.

Grafix is a cryopreserved placental membrane comprised of an extracellular matrix (ECM) rich in collagen, growth factors, fibroblasts, mesenchymal stem cells (MSCs), and epithelial cells native to the tissue

Grafix is a cryopreserved placental membrane, made of human amniotic membrane used for wound coverage

CLINICAL IndicationsNEOX100 can be used as a surgical covering, wrap or barrier. FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spr

CLINICALIndicationsNEOX 1k is a thicker cryopreserved amniotic membrane tissue that is intended for use when durable tensile strength is indicated.NEOX 1k can be used for tectonic support as a surgical covering, wrap or barrier. FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishmen

CLINICAL IndicationsNeox®Flo can be prepared by the physician as a suspension with normal saline for topical application or applied in dry form topically. It is especially useful in difficult to reach wounds that are either irregularly shaped or tunneled. The typical chronic wound patient will receive an average of 1-2 applications of Neox®Flo to facilitate healing. The dosage depends on the wound size. FDARegulated under

CLINICALIndicationsAdhesion barrier, wound covering, acts as an adjunct to soft tissue healingDirect application, wrapping or suturing around tendons, on-lay graft FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, cur

PalinGen Membrane and Hydromembrane are human allografts processed from healthy placental tissue for wound coverage. See clinical, coding and reimbursement information.

Revita is an intact human placental membrane allograft. See clinical, coding and reimbursement information.

CLINICALIndicationsStravix can be used as a surgical covering or wrap for several procedures, including but not limited to:Tendon RepairAchilles Tendon RuptureBunionectomyHallux Rigidus CorrectionFoot AmputationsFibromatosisArthrodesis

Talymed is an advanced sterile wound matrix composed of shortened fibers of poly-N-acetyl glucosamine (pGlcNAc), isolated from microalgae. See clinical, coding and reimbursement information.

CLINICALIndicationsmembrane wrap, cover or patch for soft tissuesprovides a physical covering to protect tendons and nerves at the surgical site FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue pr