AmnioMatrix - Amniotic Membrane for Ophthalmology

AmnioMatrix is an amniotic membrane graft which brings a new generation of ocular surface tissue therapy to South Africa. AmnioMatrix can accelerate the regeneration of damaged tissue and reduce discomfort and pain for the patient, associated with the reconstruction of the ocular surface.

The amniotic membrane is the innermost membrane of the placenta and it contains natural growth factors and cytokines that are integral to the development of a healthy fetus. When applied to the ocular surface, the amniotic membrane promotes wound healing and may assist with pain reduction at the affected site. The amniotic membrane allografts are thin, opaque and extremely lightweight.

The amniotic membrane is used for its high concentration of cytokines and growth factors, and acts as a potent facilitator in wound healing. Generally, the membrane is placed with the epithelial side down in contact with the wound surface in order to efficiently release the growth factors to the wound site.

The use of the amniotic membrane to cover inflamed or exposed areas favorably influences the wound healing process, as well as, reduces the levels of discomfort for the patient. The amniotic membrane conforms easily to the ocular surface and can be either glued or sutured to the ocular surface. The membrane is hydrophilic and naturally absorbs the surrounding fluids. As part of the healing process the amnion resorbs into the wound. General literature suggests that the membranes completely resorb into the wound in about 4-6 weeks¹.

Cryopreserved

Fresh amniotic membrane that is processed and stored frozen at -80°C
The epithelial layer of cells is retained as well as the important biological factors and cellular mediators
Supports epithelial healing and serves as a physical barrier for the ocular surface against the external environment

Dehydrated

Dry amniotic membrane that has had the epithelial layer of cells removed
No living cells are exposed to the patient
Membrane acts as a scaffold onto which new cells can grow once it has been placed on the wound
Provides natural healing properties to wounds with minimal inflammation and scarring

The benefits of AmnioMatrix include:

Provides a structure for cellular migration and proliferation
Contains collagen types IV, V and VII which promote cellular differentiation and adhesion
Known to be antiangiogenic
Anti-inflammatory effect
Bacteriostatic effect
Anti-adhesive and supportive in preventing scarring
Assists with pain and discomfort at affected site
Known to be non-immunogenic and low in antigenicity
Provision of a natural biological barrier

Amniotic membrane, both dehydrated and cryopreserved, is used as a substrate to replace the damaged ocular or subcutaneous tissue or as a biological dressing in:

Indications of Corneal Surface Reconstruction

Indications of Conjunctival Surface Reconstruction

Contraindications

Persistent Epithelial Defects ⁷
Anticipated delayed re-epithelialisation ⁷
Non-healing Stromal Ulcers ⁷
Partial Limbal Stem Cell Deficiency ⁸
Bullous Keratopathy
Total Limbal Stem Cell Deficiency ^9,10
Band Keratopathy ¹¹
Mooren’s Ulcer ¹²
Stevens-Johnson Syndrome ¹³

Chemical Burns ¹⁴
Descemetocoele ¹²
Cicatrizing Conjunctivitis¹⁵
Ocular Surface Squamous Neoplasia (OSSN) ¹⁶
Leaking Blebs ¹⁷
Filtering Surgery¹⁸
Symblepharon Release ¹⁹
Fornix Reconstruction ²⁰
Socket Reconstruction ²¹
Entropion Correction ²²
Scleral Melt ²³
Pterygium Surgery ²⁴

Amniotic Membrane should NOT be implanted into:

Areas with an active or latent infection
In the management of persistent epithelial defects with infectious corneal ulcers
This product is intended for single patient use only
If opened, this product cannot be re-sterilised

Collection

Placental donations are collected during the birthing process in accordance the National Health Act of South Africa. All donors complete a health questionnaire and are screened for transmissible diseases. All AmnmioMatrix samples are tested during processing for bacterial and fungal contamination and to ensure sterility of the product.

Packaging

Dehydrated

Cryopreserved

The amniotic membrane is spread on a polyester net with the epithelial side orientated onto the net. The membrane is packaged aseptically in an inner polyethylene pouch and sealed with an outer peel pouch. Dehydrated denuded human amniotic membrane is terminally sterilised by gamma-irradiation.

The amniotic membrane is processed in sterile conditions and decontaminated by antibiotic incubation. The membrane is spread over on nitrocellulose membrane with the stromal side of the amnion against the nitrocellulose membrane. Thus, the epithelial side is away from the nitrocellulose membrane.

The membrane is then placed in a polyethylene pouch with Dulbecco’s Modified Eagle Medium and Glycerol as storage media for protection against freeze injury. The membranes are cryopreserved at -80°C.

Storage

Dehydrated

Cryopreserved

Dehydrated AmnioMatrix can be stored in a clean dry setting at room temperature for up to 4 years from date of manufacture. No special storage is needed for this product.

Cryopreserved AmnioMatrix is shipped frozen on dry ice.

Once received, AmnioMatrix may be placed in a home freezer (-20°C) for up to 3 months or until expiration date printed on outer product packaging, whichever comes first.

We recommend that the size ordered is approximately 1.0 cm larger than the proposed surgical site, to be covered with amniotic membrane.

Dehydrated	Cryopreserved
1.5 cm x 1.5 cm 2.0 cm x 2.0 cm 3.0 cm x 3.0 cm 4.0 cm x 4.0 cm	2.0 cm x 2.0 cm 4.0 cm x 4.0 cm 6.0 cm x 6.0 cm

Dehydrated Amniomatrix

Cryopreserved Amniomatrix

Placement of the Dehydrated Amniotic Membrane on the wound site.

Placing the Cryopreserved Amniotic Membrane on the wound site. Removal of the nitrocellulose membrane should only be done during placement of the membrane.

HCP-AmnioMatric- -Application Techniques

Application Techniques:

A. Inlay (Graft)

The amniotic membrane is usually placed epithelial side up.
Epithelium grows over the graft, securing itself to the basement membrane.
The amniotic membrane is intended to act as a substrate or scaffold for epithelial cells to grow and is therefore incorporated into the host tissue (cornea or conjunctiva).

B. Overlay (Patch)

Amniotic membrane is usually placed epithelial side down.
Shallow corneal defects.
Epithelium grows beneath the patch, which dissolves within a few weeks.
Here the amniotic membrane functions essentially as a cover or a biological bandage ‘contact lens,’ protecting the underlying healing epithelial surface.
The intention is for the membrane to fall off or be removed over a period of time.

C. Sandwich

Support for deeper corneal ulcers.
Fill the defect with layers of amniotic membrane, epithelial side up.
Single sheet to secure the multiple layers over the top.
Top layer can be epithelial side up or down.

How to bill accounts for amniotic membrane procedures:

Step 1: Procedure code + Diagnostic code (ICD10)
Step 2: 0201 (Material stock code) and NAPPI Code + Diagnostic code (ICD10) + Authorisation Code

Product Code	Description	Size	NAPPI Code
LAM1515	Dehydrated Membrane	1.5x1.5cm	493575001
LAM2020	Dehydrated Membrane	2.0x2.0cm	493581001
LAM3030	Dehydrated Membrane	3.0x3.0cm	493583001
LAM4040	Dehydrated Membrane	4.0x4.0cm	493584001
CAM2020	Cryopreserved Membrane	2.0x2.0cm	651936001
CAM4040	Cryopreserved Membrane	4.0x4.0cm	651938001
CAM6060	Cryopreserved Membrane	6.0x6.0cm	165595001

Procedure Codes	Description	ICD-10 Diagnosis Code
3191	Blepharoplasty	H02.03
3163	Excision Papilloma	D23.1
3181, 0201	Ectropion/Entropion repair	H02.1/0
3121, 0201	Corneal transplant	H18.6
3120, 3132, 3198, 3126, 0201	Lasik POI	H52.0/1/2
3125	Pterygium	H11.0
3134	Pterygium/conjunctival cyst/ conjunctival tumour with graft used	H11.0

For additional information on ICD-10 Codes, follow the link: ICD-10 Master Industry Table – National Department of Health

Package Insert Cryopreserved (Frozen)

Package Insert Dehydrated

Case Studies

Eye Socket Reconstruction - Deepening of the Inferior Fornix

Dehydrated Amniotic Membrane as a Graft in Pterygium Surgery

Cryopreserved Amniotic Membrane as a Graft in Conjunctival Surgery

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