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Samples of the donor skin are tested for and shown to be free of bacterial Cymetra® Micronized AlloDerm® Tissue is micronized donated allograft and fungal pathogens; non-pathogenic skin bacteria may be present. human dermis, aseptically processed to remove cells and freeze-dried to remove moisture while preserving biologic components and structure of Due to limitations in testing technology, testing and donor screening cannot totally eliminate the risk that human source material will transmit disease. Cymetra® Micronized Tissue is regulated by the US Food and Drug Administration (FDA) as human tissue for transplantation. Cymetra® Cymetra® Micronized AlloDerm® Tissue is intended for homologous Micronized Tissue is processed and marketed in accordance with the FDA’s use when transplanted into sub-epidermal spaces from which such requirements for banked human tissue (21 CFR, Part 1271) and Standards tissue originates, for repair or replacement of damages or inadequate for Tissue Banking of the American Association of Tissue Banks (AATB). integumental tissues (e.g., correct soft-tissue defects, and depressed scars, Cymetra® Micronized Tissue is compliant with the AATB Standards for or for replacement of integumental tissue lost through atrophy). Tissue Banking and the state guidelines of California, Florida, New York, Each package of Cymetra® Micronized Tissue is intended for use in one LifeCell™ has determined the donor of this tissue graft to be an eligible Cymetra® Micronized Tissue is contraindicated for use in any patient who is donor based on the results of donor screening and testing records and sensitive to polysorbate 20 or any of the antibiotics listed on the package.
thereby declares the tissue to be safe for transplantation. Donor screening includes, but may not be limited to, review of relevant medical records DO NOT USE Cymetra® Micronized Tissue in the periocular, forehead
including a current donor risk assessment interview; a physical examination or glabellar areas. If Cymetra® Micronized Tissue is used in these areas, of the donor; laboratory test results; existing coroner and autopsy there is a risk of the Cymetra® Micronized Tissue entering and occluding results; as well as other information pertaining to risk factors for relevant blood vessels supplying the eye through retrograde flow, resulting in vision Donor screening and testing is performed on all tissue donors according to FDA regulations and AATB standards. Refer to the Summary of Records label provided with each graft for details of the testing.
DO NOT USE the Cymetra® Micronized Tissue if prior to rehydration it is
not uniformly white to buff in coloration.
Processing of the tissue, laboratory testing and careful donor DO NOT USE the Cymetra® Micronized AlloDerm® Tissue if it has
screening minimize the risks of the donor tissue transmitting disease to the recipient patient. As with any processed donor tissue, the Cymetra® Micronized AlloDerm® Tissue cannot be guaranteed to be Use of Cymetra® Micronized Tissue is limited to specific healthcare free of all pathogens. No long-term studies have been conducted professionals or practitioners (e.g., physicians).
to evaluate the carcinogenic or mutagenic potential or reproductive impact of the clinical application of the Cymetra® Micronized Tissue.
Unused or expired product should be discarded according to local institutional requirements. • DO NOT RE-USE Cymetra® Micronized Tissue.
Failure to follow rehydration instructions may lead to sub-optimal results.
• DO NOT STERILIZE Cymetra® Micronized Tissue.
Aseptic technique must be adhered to throughout the procedure.
• DO NOT USE Cymetra® Micronized Tissue if the foil pouch is perforated
or torn. A damaged pouch may result in degradation or contamination Cymetra® Micronized Tissue should be used within two hours following • The foil pouch that contains the Cymetra® Micronized Tissue is NOT
Use the supplied 23-gauge needle for implanting rehydrated Cymetra® STERILE. DO NOT PLACE the foil pouch in the sterile field.
Micronized Tissue. Use of a smaller gauge needle may increase the risk of the needle clogging. PrecautionsPoor general medical condition or any pathology that would limit the If the needle should become clogged during insertion, replace with a fresh blood supply and compromise healing, as well as nonvascular surgical sites, should be considered when selecting patients for implanting Gentle massage by the physician of the treated area is recommended Cymetra® Micronized Tissue as such conditions may compromise successful during and following treatment to achieve symmetry. The patient should implantation or lead to sub-optimal results. NOT massage the treated area. Transient swelling, redness and firmness Whenever clinical circumstances require implantation in a site that is can be expected to occur following treatment.
contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken. Adverse effectsPotential adverse effects which may result from placement of an implant or graft include, but are not limited to the following: wound or systemic infection; hypersensitive, allergic or other immune response; rapid resorption of graft material; and disease transmission. Because Cymetra® Micronized AlloDerm® Tissue is placed into a superficial Preparation instructions
subdermal tissue plane, there is potential for swelling, bruising, pain Important: It is the responsibility of the healthcare professional or
or irritation during the immediate post-operative period. Skin redness, practitioner to maintain recipient records for the purpose of tracing tissue discoloration and herpetic lesions have been reported on rare occasions. post-implantation. Patient tracking labels are provided for convenience.
These symptoms typically resolve without sequelae. In addition, lumpiness and a non-uniformity of contour may occur if care is not taken by the Prepare treatment area for injection. If the injection site is susceptible to physician to evenly distribute the material during placement. Firmness of herpetic outbreak, the patient may be placed on prophylactic antiviral the treated site may occur within the first 4 months, but typically resolves agents. See “Preparation for placement” for anesthetic options.
Instructions for optimal rehydration are separately enclosed in the Adverse outcomes potentially attributed to Cymetra® Micronized Tissue Cymetra® Micronized AlloDerm® Tissue package. Failure to follow must be reported promptly to LifeCell™ Corporation. rehydration instructions may lead to sub-optimal results.
Refrigerate upon receipt between 1–10˚C (34–50˚F). The expiration date for Cymetra® Micronized Tissue should be placed into a superficial sub- the Cymetra® Micronized Tissue is recorded on the outer package as a year dermal tissue plane. Cymetra® Micronized Tissue has been formulated (4 digits) and month (2 digits), the product expires on the last day of the to a consistency that will easily pass through a 23-gauge needle. Use month indicated. Do not use product after expiration date. of a smaller gauge needle may increase the risk of the needle clogging. Preparation of the injection site can be achieved using a variety of Expiration date printed on the labeling is valid as long as product is stored approaches to help maximize patient comfort during and after the refrigerated and in an unopened foil bag. placement of tissue, including: • Topical anesthetics such as lidocaine/prilocaine cream; • Regional nerve block; and • Lidocaine with epinephrine, or ice placed on the site 2-3 minutes prior Cymetra® Micronized Tissue is supplied as a dried, acellular dermal to detection. (The use of lidocaine with epinephrine may alter the clinical particulate. The Cymetra® Micronized Tissue package includes standard endpoints of certain procedures such as laser resurfacing if concurrently disposable supplies to facilitate rehydration and delivery. Refer to product rehydration Instructions for contents.
Tissue Transplant Return RecordThe Tissue Transplant Return Record (TTRR) is attached to the Instructions for Use. Please separate the TTRR from the Instructions for Use and follow the directions provided on the form for completion and return to LifeCell™ Corporation.
InquiriesContact LifeCell™ Customer Support at 908.947.1215 or 800.367.5737, or e-mail LifeCell™ at [email protected] for additional information, to place an order, or to report adverse reactions.
Cymetra® Micronized AlloDerm® Tissue is processed and distributed by LifeCell™ Corporation, One Millennium Way, Branchburg, NJ 08876 USA.
This product and certain methods are covered by U.S. and foreign patents and patents pending.
LifeCell Corporation
One Millennium Way, Branchburg, NJ 08876
Tel: 908.947.1100
Fax: 800.226.2714
LifeCell™ Customer Support
800.367.5737
www.lifecell.com
Copyright 2012 LifeCell Corporation. All rights reserved. LifeCell™, AlloDerm® and Cymetra® are trademarks of LifeCell Corporation. LifeCell Corporation holds Canadian Registration #100128.

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