MicroLyte VET

Company: Imbed Biosciences

Antimicrobial Matrix

INSTRUCTIONS

Description

MicroLyte^® VET antimicrobial matrix is a sterile, single use absorbent polymeric matrix wound matrix composed primarily of bioresorbable polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/in².

MECHANISM OF ACTION: The matrix absorbs wound fluid and forms a soft material that conforms to the wound surface and maintains a moist environment. The matrix contains silver only to prevent or minimize microbial growth within the matrix.

INTENDED USE: MicroLyte^® VET antimicrobial matrix is indicated for the management of veterinary wounds such as partial and full thickness pressure ulcers, first and second degree burns, abrasions and lacerations, and surgical wounds. MicroLyte^® VET wound matrix may be used over debrided and grafted partial thickness wounds.

INDICATIONS FOR USE: MicroLyte^® VET antimicrobial matrix may be used for management of:

● Wounds

● Partial and full-thickness wounds including first- and second-degree burns, abrasions, lacerations, donor sites, and surgical wounds

● May be used over debrided and grafted partial thickness wounds

Directions For Use

● Clean the wound area using sterile saline solution.

● If the wound is dry, moisten it with sterile saline and remove excess saline with sterile gauze.

● Avoid contact with wet surfaces until placed on a moist wound bed.

● Cut the MicroLyte^® VET antimicrobial matrix to size slightly larger than the wound. Multiple sheets can be used to tile the entire wound area.

● Apply MicroLyte^® VET antimicrobial matrix directly to wound bed. When placed on a moist wound bed, the dressing forms a soft conforming sheet.

● MicroLyte^® VET antimicrobial matrix should be used with a secondary cover dressing. Cover with a moisture retentive dressing, such as a film dressing, foam dressing, wet-to-dry gauze or other appropriate dressing. See individual cover dressing package inserts for complete instructions for use.

● All wounds should be inspected daily.

● Reapply MicroLyte^® VET antimicrobial matrix every 3 days, depending on the wound and the healing progression, or when clinically indicated (e.g. leakage, excessive bleeding, increased pain).

● To reapply, carefully remove the secondary cover dressing. MicroLyte^® VET antimicrobial matrix is normally removed with the secondary cover dressing. Any remaining MicroLyte^® VET antimicrobial matrix will be removed with normal wound cleansing.

● Change the secondary cover dressing as needed or when MicroLyte^® VET antimicrobial matrix is re-applied.

● Duration of treatment depends on wound type and healing conditions.

PRECAUTIONS FOR USE:

● This product is intended for veterinary use only.

● Warning: Frequent or prolonged use of this product may result in permanent discoloration of skin.

● Warning: Avoid use with iodophore containing products that may reduce the effectiveness of silver in the matrix.

● Secondary dressings should be used as stated in the “Directions For Use” section.

● MicroLyte^® VET antimicrobial matrix should not be used with other wound care products other than those listed in the “Directions For Use”.

● This product contains <0.5 mg/in² polyethylene glycol (400 Da).

SAFETY & EFFECTIVENESS: Preclinical testing has been performed on MicroLyte^® VET and its biocompatibility has been demonstrated through appropriate in vitro and in vivo tests, including cytotoxicity, acute systemic toxicity, subacute/subchronic toxicity, acute intracutaneous reactivity, skin sensitization, and tissue implantation tests. Sustained antimicrobial activity for up to 3 days has been demonstrated by relevant standard in vitro microbiological assays in simulated wound fluid. MicroLyte^® VET was shown to be effective in killing more than 4 log10 CFUs of microbes most frequently associated with wound infections, including, S. aureus (ATCC 6538), MRSA (ATCC 33591), VRE (ATCC 55175), P. aeruginosa (ATCC 9027), E. coli (ATCC 8739), K. pneumoniae (ATCC 4352), C. tropicalis (ATCC 750) and C. albicans (ATCC 10231). The product has been determined to be non-pyrogenic.

Contraindications

Do not use on patients that are sensitive to silver or that have had an allergic reaction to MicroLyte^® VET antimicrobial matrix or one of its components.

STORAGE CONDITIONS: Store at room temperature (15°C/59°F - 30°C/86°F). Keep dry.

If further information is needed, please contact Imbed Biosciences Inc.

How Supplied

MicroLyte^® VET antimicrobial matrix is individually packaged in foil pouches and supplied in boxes of 5 units. Sterilization by E-beam radiation. Sterility is guaranteed unless pouch is damaged or opened. Single use only.

REF. 99000 2” x 2” (5 cm x 5 cm)

REF. 99001 4” x 4” (10 cm x 10 cm)

REF. 99002 4” x 9” (10 cm x 23 cm)

REF. 99003 6” x 6” (15 cm x 15 cm)

MANUFACTURED BY

Imbed Biosciences, Inc., 5520 Nobel Drive, Suite 100, Madison, WI 53711

Ph: 608.237.1525

Fax: 608.237.1271

www.imbedbio.com

Made in USA

©2021 MicroLyte^® is a registered trademark of Imbed Biosciences, Inc.

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