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AmnioPlast 1™ is a sterile dehydrated monolayered human amnion allograft
AmnioPlast 1
AmnioPlast 1™ is a sterile minimally processed, air-dried monolayered amnion allograft derived from the human amniotic tissue which is designed to act as a wound cover that aids in the healing process of Ocular Surface Disorders (OSDs).
As low as
₹710.00
- About Product
AmnioPlast 1 allografts are intended for use as a biological ocular bandage or barrier following repair or reconstruction procedures in the treatment of ocular surface disorders. It is aseptically processed and dehydrated while preserving its various biological components and its native structure. It can be used both in an outpatient setting along with a soft bandage contact lens, as well as surgically
Product Specifications
AmnioPlast 1 is a dry, thin and bio-absorbable wound cover derived from the amnion layer of the placental tissue
Layers: Amnion layer
Thickness: Not less than 20 microns
Tensile Strength: Not less than 0.25 N
Transparency: Clear membrane (>75% clarity)
Total Protein: Not less than 150 μg/cm^2
Moisture Content: Not more than 15%
Embossing: "LC" as a guide to support correct placement on the wound
Composition
AmnioPlast 1 is composed of:
Extracellular matrix (ECM) of the Human Amnion Membrane: Acts as a natural biocompatible scaffold and a biological barrier
AGNES Proprietary Processing Technology
Donated placental tissues go through the steps of:
Donor Screening: Includes testing for presence of infectious agents
Tissue Washing & Dehydration: Microbial and red cell contaminants removed and tissue is air dried
Tissue removal: Chorion is removed
Re-Washing & Dehydration: Washed and air drie
Cutting & Packaging: Tissues are cut using lasers, placed inside multiple poly-foil peel pouches and then in an outer carton
Sterilization: Terminally sterilized using gamma irradiation
Shapes and Sizes
To ensure limited or no wastages, AmnioPlast 1 is available in different shapes (square, rectangle and circle) and sizes. 3 cm x 3 cm, 1.5 cm diameter
- Product Advantages
It can be used as a biological bandage or barrier applied to the ocular surface following repair or reconstruction procedures. Here are some of its advantages
Safety
Immunologically privileged due to very low levels of HLA antigens and no immune rejection, and therefore can safely be used as an allograft without requiring tissue matching between donor and patient
Terminal sterilisation provides additional safety by ensuring that the product is free from microbial contaminants
Rigorous donor screening and selection protocols that meet or exceed industry standards
Screens for infectious agents like:
- HIV-1/2 antibody & HIV antigen
- Hepatitis B surface antigen
- Hepatitis B core antibody
- Hepatitis C antibody
- Syphilis
- Malaria
- HTLV I & II antibody
- CMV IgG
- HIV-1 (NAT)
- HCV (NAT)
Storage and Shelf-life
Does not require refrigeration and can be stored in a clean and dry environment at ambient room temperature.
Shelf-life of 2 years
Ease of Use
Easy-to-apply and ready-to-use
Single-step rehydration
Optimised sizes and specifications for different wound types
Easy to determine the orientation of membrane allografts (2 distinct sides: epithelial and basement membrane)
- Clinical Uses
Human Amnion allografts like AmnioPlast 1 act as biological barrier membranes and which are bioabsorbable. The allografts are relatively transparent for good cosmetic outcomes. They have been used in the following non-surgical and surgical applications
Non-surgical Applications
Recurrent Corneal Erosions
Corneal ulcers
Acute chemical and thermal burns
Neurotrophic ulcers
Excessive dry eye associated conditions
Non-healing epithelial defects
Post-infectious keratitis (herpetic, vernal, bacterial)
Surgical Applications
Pterygium excision
Conjunctival Chalasis
Chemical and thermal burns
Corneal ulcers
Corneal erosions
Glaucoma filtration device insertion
- Case Studies
Stevens Johnson Syndrome | 29-year-old Female
Following a single application of 3 x 3 cm AmnioPlast 1, complete healing of the surrounding conjunctival tissues was achieved
Application Procedure
OPD Application
Insertion of the lid speculum:
The lid speculum is inserted after anesthetising the patient. It is first inserted in the upper lid, followed by the lower lid
Hydration of the allograft:
The AM is moistened with any sterile solution to help soften it
Placement of AmnioPlast 1:
Ensure that the letters LC are displayed correctly from left to right before the placement of the allograft.
Lid speculum removal:
Remove the speculum from the lower lid followed by the upper lid gently while pulling away from the cornea and the lens
Surgical Application
Unpacking:
Unpack the outer and inner cover carefully maintaining sterility
Resizing:
Check whether resizing is required or not. If needed, measure the pathologically defective area with the help of a caliper. Then considering double the amount of the defect, resize the AmnioPlast 1 while it is in a dry state. Resizing is done with the help of corneoscleral scissors
Soaking:
Post resizing, the AM is moistened with any sterile solution to help soften it. If resizing is not required, then the AM is directly put into the sterile solution
Glued:
After managing the affected corneal ocular surface properly, AmnioPlast 1 is placed over it and glued with fibrin glue
Why Choose LifeCell?
Proprietary Technology
Produced using LifeCell's proprietary AGNES processing technology, to provide an effective allograft with excellent handling characteristics
Licenced & Accredited
First Tissue Bank outside the US to be accredited with AATB for placental tissues, and licenced by NOTTO (National Organ and Tissue Transplantion Organization)
Quality Assurance
Designed and developed by strictly adhering to Good Manufacturing Practices (GMP) & Good Tissue Practices (GTP) protocols
Frequently
Asked Questions
Frequently Asked Questions
Wish To Know More?
Prior to donation, the donor’s medical and social history are screened for medical conditions or diseases that would contraindicate the donation of tissues in accordance with current policies and procedures approved by LifeCell. Donor blood samples taken at the time of collection are tested negative/non -reactive for relevant communicable and infectious disease agents at LifeCell International, which has requisite national and/or international accreditations.
- HIV-1/2 antibody & HIV antigen
- Hepatitis B surface antigen
- Hepatitis B core antibody
- Hepatitis C antibody
- Syphilis
- Malaria
- HTLV I & II antibody
- CMV IgG
- HIV-1 (NAT)
- HCV (NAT)
In addition, LifeCell provides a certificate of analysis (CoA) for more details, on request.
Yes, all our products are ready-to-use.
No, each product is for single use only.
Each product is for single patient use only.
No, our products do not contain any live cells.
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