Placental Tissue
4D Amnio Patch
A dual-layer amnion allograft designed for use in robotic procedures, and equally suited to open and laparoscopic surgery or use as a wound barrier. Where many placental grafts pair amnion with chorion, this patch is two layers of amnion.
Schematic representation of graft structure
Description
A dual-layer amnion allograft specifically designed for use in robotic procedures, and equally suitable for open and laparoscopic surgery or for use as a wound barrier.
The key structural difference from many placental grafts is composition: rather than combining amnion with chorion, this patch is built from two amnion layers and is chorion-free. It is omni-directional, so orientation at placement is not a constraint.
Sizes run from 1 × 1 cm through 4 × 8 cm. At less than half the thickness of an amnion/chorion patch the graft is still strong, which makes it easier to handle and place — a practical advantage in colorectal, urology, OB/GYN and plastic surgery cases.
Indications
- Robotic surgery
- Colorectal
- Urology
- OB/GYN
- Plastic surgery
- General surgery
- Thoracic
- Spine and orthopedics
Benefits
- 01Dual-layer amnion — chorion-free
- 02Designed for robotic procedures
- 03Suitable for open and laparoscopic surgery
- 04Omni-directional — no orientation requirement
- 05Surgical focus rather than wound care
- 06Less than half the thickness of an amnion/chorion patch
- 07Sizes from 1 × 1 cm to 4 × 8 cm
Technical Specifications
- Tissue source
- Human amniotic membrane
- Construction
- Dual layer amnion, chorion-free
- Orientation
- Omni-directional
- Sizes
- 1 × 1 cm through 4 × 8 cm
- Regulatory pathway
- HCT/P — Section 361 PHS Act, 21 CFR Part 1271
Ordering Information
4D Amnio Patch
| Catalog No. | Description | Size |
|---|---|---|
| 4D-AP-11 | Amnion patch, dual layer | 1 × 1 cm |
| 4D-AP-23 | Amnion patch, dual layer | 2 × 3 cm |
| 4D-AP-44 | Amnion patch, dual layer | 4 × 4 cm |
| 4D-AP-46 | Amnion patch, dual layer | 4 × 6 cm |
| 4D-AP-48 | Amnion patch, dual layer | 4 × 8 cm |
Regulatory Status
4D Amnio Patch is a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271. It is minimally manipulated and intended for homologous use, and therefore does not require FDA pre-market approval. It has not been cleared or approved by the FDA.
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