Miro3D® Wound Matrix

Miro3D® Wound Matrix

Miro3D® Wound Matrix is a three-dimensional, hepatic-derived, and porous wound care matrix. It is 2cm thick and designed to fill deep, tunneling, and irregular wound beds. Supplied sterile.

Reprise Biomedical

Reprise Biomedical is focused on the development and commercialization of biological matrices that offer advanced solutions for healing. Their products are derived from porcine liver utilizing a patented perfusion decellularization technology.

Fax:(952) 856-5085 Website: www.reprisebio.com

Benefits

• Thick collagen sheet matrix designed for deep and tunneling wounds.
• Open and porous structure provides protective environment for wound management
• Available in four sizes that can be cut and shaped to fill and maintain direct contact with irregular wound beds

Indications

Miro3D® Wound Matrix is indicated for the management of wounds, including: partial- and full-thickness wounds; pressure ulcers; venous ulcers; chronic vascular ulcers; diabetic ulcers; tunneled, undermined wounds; trauma wounds (abrasion, lacerations, partial-thickness burns, skin tears); drainage wounds; and surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence).

Contraindications

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.

Warnings and Precautions

Miro3D® Wound Matrix 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.

Adverse Effects/Reactions

The following complications are possible with the use of wound dressings. If any of these conditions occur, the device should be removed: allergic reaction; excessive redness, pain, swelling, or blistering; fever; infection; chronic inflammation; non-healing wound.

Storage Requirements

Miro3D® Wound Matrix 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), month (2 digits), and day (2 digits).

How Supplied/Sizing

2cmx2cm, 3cmx3cm, 5cmx5cm, 10cmx5cm; 2cm thick.

HCPCS Code

A2025

Product features

check_circle Assigned HCPCS code

check_circle Minimally manipulated

check_circle Dehydrated

cancel Desiccated

cancel Flowable

cancel Micronized

check_circle Sheet form

cancel Requires refrigeration

check_circle Shelf life greater than 2 years

cancel Shelf life limited

check_circle Indicated for acute wounds

check_circle Indicated for chronic wounds

check_circle Indicated for diabetic ulcers

check_circle Indicated for pressure ulcers

check_circle Indicated for second-degree burns

check_circle Indicated for surgical wounds

cancel Indicated for third-degree burns

check_circle Indicated for venous ulcers

cancel Contact manufacturer for usage guidelines

Other features

check_circle Educational Material Available

check_circle Free Samples/Trials Available

cancel Published Clinical Article Available

Recommended Use

Acute Wounds
Chronic Wounds
Deep Wounds
Diabetic Foot
Necrotizing Fasciitis
Pressure Ulcers
Traumatic Wounds
Venous Ulcers

Mode of Use/Application

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.
Miro3D® Wound Matrix should be placed in maximum possible contact with healthy, well-vascularized tissue as a scaffold which provides a protective environment for the wound.
If desired, secure Miro3D® Wound Matrix with the physician’s preferred fixation method.
Use an appropriate non-adherent primary wound dressing over Miro3D® Wound Matrix 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® Wound Matrix moist, and keep all layers securely in place.
Discard any unused portion of the Miro3D® Wound Matrix 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® Wound Matrix may gradually peel. Carefully remove any remaining loose product around the edge as needed. Do not remove any remaining Miro3D® Wound Matrix 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.

Removal & Change Frequency

As healing occurs, sections of Miro3D® Wound Matrix may gradually peel. Carefully remove any remaining loose product around the edge as needed. Do not remove any remaining Miro3D® Wound Matrix 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.

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