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Miro3D® Fibers
• Designed for irregular wound beds
• A fiber option of Miro3D® Wound Matrix
Reprise Biomedical
Reprise Biomedical
Reprise Biomedical is focused on the development and commercialization of biologic matrices for surgical wound care and soft tissue reinforcement. Their products are derived from porcine liver which utilizes a patented perfusion decellularization technology.
100mg, 250mg, 500mg, 700mg.
The Miro3D® Fibers wound matrix is intended for the management of wounds including: partial- and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, tunneled wounds, undermined wounds, trauma wounds (abrasions, lacerations, partial-thickness bums, and skin tears), draining wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence).
This device is derived from a porcine source and should not be used in patients with known sensitivity to porcine material.
This device is not indicated for use in third-degree burns.
Miro3D® Fibers is supplied sterile for single use only. Reuse of a single-use device creates a potential risk of patient or user infections and may compromise the device functionality, which may lead to illness or serious injury.
Do not resterilize, as the safety and performance has not been evaluated for this scenario. This is a single-use device. Reuse of this device creates a potential risk of patient infections.
Do not use a device past the expiration date as the safety and performance has not been evaluated for this scenario.
Do not use if the package or seal is opened, damaged, or compromised. A damaged package could result in a breach of sterility or device damage, which may lead to illness or serious injury.
After use, handle and dispose of all unused product and packaging in accordance with accepted medical practice and applicable local, state, and federal laws and regulations. This is a single-use device. Reuse of this device creates a potential risk of patient infections.
Discard device if mishandling has caused possible damage or contamination as it may have resulted in breach of sterility or compromised device functionality.
Miro3D® Fibers should not be used until excessive exudate, bleeding, and acute swelling are controlled and active infections have been cleared, as it may not conform to the site properly and not perform as desired.
Potential adverse events include: allergic reaction; excessive redness, pain, swelling, or blistering; fever; infection; chronic inflammation; non-healing wound.
Miro3D® Fibers is a sterile medical device that should be stored in a clean, dry location at room temperature, in its original package. Avoid prolonged exposure to elevated temperatures as it may compromise device functionality.
The product expiration date is indicated as year (4 digits) and month (2 digits). The product expires after the last day of the month indicated.
Prepare the wound using standard methods ensuring that the wound is free of debris and devitalized tissue. An initial debridement of the wound may be necessary to ensure the wound edges contain viable tissue. Using aseptic technique, manually or with forceps, place the product directly in contact with the wound surface. Miro3D® Fibers should be placed in maximum possible contact with healthy, well-vascularized tissue as a scaffold which provides a protective environment for the wound. If choosing to apply the product dry, it may be hydrated in situ with sterile saline or lactated Ringer’s solution. Use an appropriate non-adherent primary wound dressing over Miro3D® Fibers to prevent it from adhering to the dressing and to protect the integrity of the applied product and not disrupt the wound site. Apply an appropriate secondary dressing that will manage the wound exudate, keep Miro3D® Fibers moist, and keep all layers securely in place. Discard any unused portion of the Miro3D® Fibers product and the package in accordance with accepted medical practice and applicable local, state, and federal laws and regulations. As healing occurs, sections of Miro3D® Fibers may not integrate. Carefully remove any remaining loose product as needed. Do not remove any remaining Miro3D® Fibers that has integrated. If the wound is free of infection and necrosis but not fully epithelialized, follow standard clinical protocol for additional application or therapy.
