- What is Amniotic Membrane Allograft?
- Amniotic Membrane Allograft CPT Code
- Amniotic Membrane Allograft FDA Status
- Amniotic Membrane Human Grafts
- Amniotic Membrane Allograft Dermacyte
- Amniotic Membrane Allograft Aril
- Amniotic Membrane Allograft EpiFix
- Amniotic Membrane Allograft BioLab Sciences
What is Amniotic Membrane Allograft?
An amniotic membrane allograft is a medical product derived from the innermost layer of the placenta, specifically the amnion. This tissue has unique biological properties that promote healing, reduce inflammation, and prevent scar tissue formation. It is often obtained after planned cesarean deliveries, where the donor is carefully screened to ensure the tissue is free from infections or diseases. Once harvested, the amniotic membrane is processed and preserved for medical use in various surgical and wound care settings.
In clinical practice, amniotic membrane allografts are used for ophthalmic surgeries, chronic wound treatment, and orthopedic repairs. They provide a natural scaffold for cell growth, releasing growth factors that aid in tissue regeneration. The allograft can be applied as a sheet, graft, or injectable formulation, depending on the treatment requirement. Its biocompatibility makes it suitable for patients with minimal risk of immune rejection, allowing for faster and more effective recovery.
Amniotic Membrane Allograft CPT Code
The CPT (Current Procedural Terminology) code for amniotic membrane allograft depends on the type of procedure and method of application. For ophthalmic use, such as in pterygium surgery, CPT codes like 65778 or 65779 are commonly applied, depending on whether the graft is sutured or glued. For wound care applications, there are separate codes for the initial application versus subsequent applications, such as 15271–15278 for skin substitutes on various anatomical locations.
Healthcare providers must select the correct CPT code to ensure accurate billing and insurance reimbursement. This involves documenting the specific indication, the size of the graft, and whether it was applied as part of a surgical repair or as a wound dressing. Proper coding also helps in maintaining compliance with insurance requirements and avoiding reimbursement delays.
Amniotic Membrane Allograft FDA Status
In the United States, amniotic membrane allografts are regulated by the U.S. Food and Drug Administration (FDA). Many products fall under Section 361 of the Public Health Service Act as human cells, tissues, and cellular and tissue-based products (HCT/Ps), meaning they meet criteria for minimal manipulation and homologous use. This classification allows them to be marketed without premarket approval as long as they follow specific guidelines.
However, if the product is more than minimally manipulated or intended for non-homologous use, it may require a biologics license or premarket approval from the FDA. Manufacturers must ensure donor screening, sterile processing, and proper labeling to meet regulatory requirements. Healthcare providers should always verify a product’s FDA status before use to ensure compliance with federal law.
Amniotic Membrane Human Grafts
Human amniotic membrane grafts are sourced from healthy, consenting mothers during planned cesarean deliveries. The tissue is carefully recovered in a sterile environment and processed to remove blood, cellular debris, and other contaminants. It is then preserved either through cryopreservation, dehydration, or lyophilization to maintain its biological activity until it is ready for clinical use.
These grafts are applied in various medical specialties, including ophthalmology, dermatology, orthopedics, and podiatry. They provide a protective barrier, reduce pain, and accelerate healing in chronic wounds, burns, and surgical sites. Because they are naturally anti-inflammatory and anti-fibrotic, human amniotic grafts are particularly valuable in cases where scarring could impair function, such as in corneal surgery.
Amniotic Membrane Allograft Dermacyte
Dermacyte is a commercially available amniotic membrane allograft product designed for wound healing applications. It is processed to retain the biological properties of the amnion while ensuring sterility and safety for patient use. Dermacyte comes in sheet form and can be applied directly to wounds such as diabetic ulcers, venous leg ulcers, or surgical incisions.
The product’s appeal lies in its ease of use and ability to integrate into the wound bed, supporting the body’s natural healing mechanisms. Clinical studies have shown that Dermacyte can reduce healing time and improve outcomes for patients with chronic, non-healing wounds. It is often used alongside other wound care therapies for maximum effectiveness.
Amniotic Membrane Allograft Aril
Aril is an amniotic membrane allograft brand that is specifically designed for ophthalmic use. It comes in a sterile, ready-to-use package and can be applied without the need for thawing or extensive preparation. Aril helps to restore the ocular surface, reduce inflammation, and promote epithelial regeneration in patients with corneal defects or injuries.
This product is frequently used in cases of persistent epithelial defects, pterygium excision, and corneal ulcers. Its rapid application process makes it suitable for both operating room and office-based procedures. By protecting the eye and enhancing tissue repair, Aril helps patients recover vision and comfort more quickly.
Amniotic Membrane Allograft EpiFix
EpiFix is one of the most widely known amniotic membrane allograft products on the market. Manufactured by MiMedx, it is available in dehydrated form and can be stored at room temperature. EpiFix has a wide range of applications, including chronic wound healing, sports injuries, and surgical reconstruction.
EpiFix works by delivering a concentrated dose of growth factors and extracellular matrix proteins directly to the injured area. These components stimulate the patient’s own cells to repair damaged tissue more effectively. Its versatility and ease of storage make EpiFix a preferred choice for many wound care specialists and surgeons.
Amniotic Membrane Allograft BioLab Sciences
BioLab Sciences produces amniotic membrane allograft products for use in regenerative medicine. Their offerings include both sheet and injectable forms of amniotic tissue, enabling clinicians to choose the most appropriate format for each case. BioLab’s proprietary processing techniques aim to maximize the retention of the tissue’s healing properties.
These products are used in diverse medical fields, from orthopedics to podiatry to dentistry. Whether applied to a chronic wound or injected into a joint to reduce inflammation, BioLab’s amniotic allografts are designed to accelerate healing while reducing patient discomfort. The company emphasizes safety, quality control, and compliance with regulatory standards.
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