fbpx

XWRAP

XWrap dry

OVERVIEW

XWRAP® is a minimally-manipulated, chorion-free, human amnion allograft that is processed to preserve the amnion’s native qualities. Procured from prescreened, live, healthy donors, XWRAP® is aseptically recovered, processed and packaged to provide viable human tissue for use as an adhesive barrier or for points of localized inflammation.

XWRAP® is a simple, versatile, and easy-to-use anti-adhesive, anti-inflammatory, and anti-microbial barrier that protects the natural planes of the human body. XWRAP® is intended for, but not limited to use in nerve, tendon, and ligament applications. XWRAP® is the intermediate amniotic epithelial layer of the placenta. This layer is a rich source of essential growth factors, Type I, II, III, V, and VI collagen, as well as fibronectins and laminins. These factors have the unique ability to suppress pain and minimize scar formation. XWRAP® is a chorion free product.(1-5) XWRAP® is recovered during a Cesarean delivery from healthy, pre-screened donors, and is processed to preserve the structural integrity of the amniotic epithelial membrane. A Clinical Laboratory Improvement Amendment (CLIA) certified lab that meets or exceeds the current donor screening regulations tests XWRAP® to minimize the risk of communicable diseases. All donors’ medical history and behavior is assessed and evaluated following United State Public Health Service (USPHS) guidelines. XWRAP® is an allograft tissue that is regulated under section 361 of the PHS Act and meets the criteria of Title 21 Code for Federal Regulation (CFR)1271.3 and 1271.10. From tissue recovery, tissue processing, and packaging, Applied Biologics ensures that each piece of XWRAP® has been carefully screened and meets industry standards for transplantation.

Expedited Healing

Scar Tissue

Scar Tissue Formation After Typical RC Repair

Native Tissue Regeneraton

Native Tissue Regeneraton with Biologic Augmentation

Surgical Applications

XWRAP® is a chorion-free, amniotic membrane allograft that can be used as a biological wrap or patch at any surgical site to minimize post-operative adhesions, reduce inflammation and further promote soft tissue healing. XWRAP® can be used as a biologic augmentation to a variety of orthopedic repairs including:

Shoulder Arthroscopy

Shoulder Reconstruction

Knee Arthroscopy

Knee Reconstruction

Meniscal Repairs

Meniscal Transplantation

Articular Cartilage Restoration

Orthopedic Trauma

Foot & Ankle Repairs

 

Features & Benefits

Simple: No suturing is required

Versatile: Available in multiple sizes

Easy to Use: Membrane is orientation neutral

Chorion-Free: Preferred in Orthopedics

Storage & Handling

XWRAP® can be stored in ambient room temperature

XWRAP® has a two-year shelf life

XWRAP® is packaged sterile and comes in three options

− Hydro Plus

− Dry

− Dry without mesh

Packaging includes a tissue-tracking card and patient labels for billing

XWRAP® is packaged for single patient/one-time use only

Sizing

 XWRAP® is available in standard sizes and can be cut to size during surgery to conform to the application:

  • 1x1
  • 1x2
  • 1x4
  • 1x6
  • 1x8
  • 2x2
  • 2x4
  • 2x6
  • 2x8
  • 4x4
  • 4x6
  • 4x8

SURGICAL TECHNIQUE

Caution: The outer pouch is NOT sterile.
The inner pouch, which contains the X-WRAP® membrane, is sterile.

Note: X-WRAP® does not have to be sutured.

1

Step one

Peel back the outer pouch, and drop the inner pouch onto the sterile field, ensuring that the inner pouch does not contact any portion of the non-sterile field.

2

Step 2

XWRAP® Hydro Plus is packaged in between two piecesofmesh; XWRAP® DRY is packaged with a single layer of mesh.

3

Step 3

Prior to removing the top layer of mesh, the surgeon may cut thesterilemembranewith scissors to fit the appropriate size for the procedure.

4

Step 4

Utilizing two Adson Forceps, grasp the edge or corner of the top layer of mesh and begin to peel off the top layer. Identify on which side the translucent membrane (yellow in color) is attached.

5

Step 5

Place the membrane against the affected nerve, tendon or ligament and peel away any remaining mesh.

6

Step 6

The surface of the membrane can be made smooth by irrigating with 1 milliliter of sterile saline, and utilizing either the tip of your finger or a Freer Elevator to smooth the surface.

OVERVIEW 

XWRAP® is a minimally-manipulated, chorion-free, human amnion allograft that is processed to preserve the amnion’s native qualities. Procured from prescreened, live, healthy donors, XWRAP® is aseptically recovered, processed and packaged to provide viable human tissue for use as an adhesive barrier or for points of localized inflammation.

STRUCTRAL QUALITIES PRESERVED  

XWRAP® is carefully processed to preserve the structural qualities of the amniotic membrane. The placental organ is a native source of collagen types I, III, IV, V, and VII as well as fibronectin and laminin. It also contains fibroblasts and growth factors, modulates, cytokine and growth factor levels, and has been shown to have unique properties, including the ability to suppress pain, fibrosis, and bacteria, and to promote wound healing.1-7

POST-OPERATIVE FIBROSIS MANAGMENT

Adhesions and post-operative scarring can mitigate the outcome of any surgical procedure. Human amnion can serve as adjunctive tissue to reduce post-operative surgical adhesions in many surgical procedures; it is, therefore, reasonable that human amnion is a suitable interposition membrane which can reduce postoperative fibrosis and consequent scar adhesions in many operative procedures.6-7

CHORION-FREE ALLOGRAFT AND IMMUNE PRIVILEGE

XWRAP® is a chorion-free product. The placental organ is processed to remove the chorion layer, which may produce an immune response in recipients who are not compatible with the donor’s tissue type. XWRAP® contains only amniotic tissue; amnion surface epithelial cells do not express HLA- A, -B, -C, or -DR or β2-microglobulin; the amniotic membrane is an immuneprivileged tissue and rarely causes immunologic rejection.8 Amnion has been used successfully as a graft without concern for tissue typing and matching of the donor to the host; this has led to the characterization of the placental organ as “immune privileged,” as published in numerous scientific journals.9-11 This immune privilege, and structural and biologic qualities of amniotic tissue makes XWRAP® an ideal alternative to both cadaveric and synthetic in vivo soft-tissuedefect coverings.

Product Summary

  • Physical covering protects the tissue in vivo

  • Physical covering protects the tissue in vivo

  • Simple, sutureless allograft placemen

  • Amniotic membrane has low risk of immunogenicity

  • Fully resorbable in vivo during healing process

  • Applications in virtually any surgical procedure where the formation of scar tissue or adhesions is a concern

  • Reduce formation of fibrotic mass at surgical site

  • Stored at ambient temperature

Donor Screening

  • Quality systems and validated processes ensures patient safety from the initial donor consultation to the surgeon’s transplantation of an Applied BiologicsTM allograft.

  • Comprehensive medical and social histories are thoroughly reviewed by trained, qualified personnel on every donor.

  • All donations are reviewed for eligibility by processor Medical Director.

  • Processor’s donor acceptance criteria are established and maintained by a Medical Review Board.

Safety Testing

All representative samples are tested for infectious diseases, including testing for AIDS with Nucleic Acid Testing (NAT by TMA), the newest and most reliable test to confirm the presence or absence of HIV and HCV early following exposure. Our comprehensive battery of testing also includes, but not limited to: HIV-1, HIV-2, HB Core, RPR, HCV-Ab, HBs Ag, NAT HIV-1/HCV/HBV. All test results are evaluated by the Quality Systems Director and Medical Director.

Regulatory

The Applied BiologicsTM line of reimbursement-eligible human allograft is regulated by the FDA Center for Biologics Evaluation and Research (CBER) which regulates HCT/Ps under 21 CFR Parts 1270 and 21 CFR Part 1271 and Section 361 of the Public Health Service Act; accordingly, all of our allograft meets the definitions of “minimally manipulated” and “homologous use” requirements.

REFERANCE

1. Fukuda K, Chikama T, Nakamura M, and Nishida T. (1999) Differential distribution of subchains of the basement membrane components type lV collagen and laminin among the amniotic membrane, cornea, and conjunctiva Cornea, 18(1):73-9.
2. Kanayama N, Terao T, Kawashima Y, Horiuchi K, and Fujimoto D. (1995) Collagen types in normal and prematurely ruptured amniotic membranes. American Journal of Obstetrics and Gynecology, 153(8):899-903.
3. Koizumi NJ and et al. (2000) Growth factor mRNA and protein in preserved human amniotic membrane. Current Eye Research, 20(3):173-7.
4. Underwood MA, Gilbert WM, Sherman MP. (2005) Amniotic Fluid: Not Just Fetal Urine Anymore. Journal of Perinatology, 25:341-348. DOI:10.1038/sj.jp.7211290.
5. Rennie K, and et al. (2012) Applications of Amniotic Membrane and Fluid in Stem Cell Biology and Regenerative Medicine. Stem Cells International. DOI: 10.1155/2012/721538
6. Silini A, Parolini O, Huppertz B and Lang I. (2013) Soluble factors of amnion-derived cells in treatment of inflammatory and fibrotic pathologies. Current Stem Cell Research and Therapy, 8:6-14. DOI: 10.2174/1574888X113080100003.
7. Solomon A, and et al. (2005) Suppression of inflammatory and fibrotic responses in allergic inflammation by the amniotic membrane stromal matrix. Clinical and Experimental Allergy, 35(7):941-8.
8. Adinolfi M, Akle CA, McColl I, and et al. (1982) Expression of HLA antigens, β2-microglobulin and enzymes by human amniotic epithelial cells. Nature, 295:325–327.
9. Insausti CL, Blanquer M, Garcia-Hernandez AM, Castellanos G, and Moraleda JM. (2014) Amniotic membrane-derived stem cells: immunomodulatory properties and clinical applications. Stem Cells and Cloning: Advances and Applications, 2014:753-763.
10. Parolini O, and et al. (2008) Concise Review: Isolation and Characterization of Cells from Human Term Placenta: Outcome of the First International Workshop on Placenta Derived Cells. Stem Cells, 26:300-311.
11. Akle CA, Adinolfi M, Welsh KI. (1981) Immunogenicity of human amniotic epithelial cells after transplantation into volunteers. Lancet 2:1003–1005.