Signature APatch is a cryopreserved, minimally manipulated amniotic membrane allograft for homologous use as a wound barrier (cover) or covering (physical barrier).
INTENDED USE: Signature APatch is a precision cut matrix, designed for application directly to acute or chronic wounds to establish a cover or barrier. This includes but is not limited to: venous leg ulcers, pressure ulcers, diabetic foot ulcers, surgical wounds, burns, and wounds with exposed tendon, muscle, and/or bone. It is directly applied to the wound weekly for up to 12 weeks or until the wound is closed as a part of a semi-wet dressing standard of care.
CLAIMED BENEFITS: The hexagon shape allows for coverage over many wound shapes and multi-directional expansion to cover unique wound sizes and morphology.
OPTION: Signature APatch is produced in a single size configuration: hexagon patch with 2.5 cm sides, measuring 5.0 cm in diameter, and a total surface area of 16 cm squared. Signature APatch is supplied as a cryopreserved tissue, prepared and packaged aseptically in a 15 mL cryovial. Signature APatch is thawed in a sterile gloved hand for 5 minutes, applied to a wound or injury site using sterile forceps following wound preparation. Signature APatch may be cut and shaped to appropriate size for application, may be used with tissue adhesives or semi-wet dressings to apply the allograft to the site if necessary.
Signature APatch, 2.5cm sides, 5.0cm diameter: Q4260
Manufacturer: Signature Biologics
Information retrieved from manufacturer and/or FDA-approved labels