Activate Matrix

Overview

Per the manufacturer's brochure, designed as a barrier or wound cover.

Manufacturer

Nvision Biomedical Technologies, Inc. Tissue processed by Sequence Life Science, Inc.

Distributor

Innovative Wound Consultants (IWC), exclusive distributor per the brochure

Tissue type

Human placental-derived allograft: amniotic and chorionic membranes and intermediate (spongy) layer

Processing

Minimally manipulated, dehydrated; terminally sterilized, verified to a 10^-6 SAL

Regulatory status

Described in the brochure as 361 HCT/P

HCPCS Level II code

Q4301, Activate Matrix, per square centimeter (as printed in the brochure)

Intended use (brochure)

Natural biologic wound covering or skin substitute for cutaneous wounds, applied by qualified health care professionals in a physician office, outpatient or inpatient setting

Storage

Foil packaging system: store in a clean, dry place at a controlled ambient temperature of 15-30 C (59-86 F). Do not freeze or refrigerate.

Handling (IFU)

Single patient use on a single occasion. Do not re-sterilize. Once the seal is broken the allograft must be transplanted or discarded; use within 8 hours of opening or hydration.

Shelf life

See the expiration date on the package label (no fixed shelf life is printed in the brochure or IFU)

Donor screening (brochure)

Tissue from fully consented mothers undergoing full-term c-sections; donors screened to FDA and American Association of Tissue Banks standards

Clinical trials

Fortify Medical reports randomized controlled trial(s) for this product. Trial data is not included in the manufacturer brochure.

Specs & sizes

Resources

Source: Activate Placental-Derived Allograft brochure (MAR-ACT-001 Rev. B, Nvision Biomedical Technologies) and Activate Matrix Allograft Package Insert (PK-HCTP-021 Rev A). The brochure prints sizes without a unit; shown here in cm.

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