PeriSeal Tissue Patch

This page contains information on PeriSeal Tissue Patch for veterinary use.
The information provided typically includes the following:
  • PeriSeal Tissue Patch Indications
  • Warnings and cautions for PeriSeal Tissue Patch
  • Direction and dosage information for PeriSeal Tissue Patch

PeriSeal Tissue Patch

This treatment applies to the following species:
Manufacturer: Avalon Medical

Innovative Veterinary Surgical Products

PeriSeal™ stabilized pericardium is intended for use in all veterinary applications requiring soft tissue buttressing. This product is not intended for human use.

PeriSeal Tissue Patch Indications

- PeriSeal™ is indicated for use in the repair of soft tissue deficiencies and fascial defects.

- PeriSeal™ is useful in the repair of abdominal and thoracic wall defects, muscle flap reinforcement, pelvic floor reconstruction as well as herniation and biopsy wound repair.

- PeriSeal™ is for internal use only.

Product Description

PeriSeal™ is a durable, non-absorbable, stabilized pericardium patch. Proprietary processing yields an acellular, crosslinked tissue with exceptional handling, elasticity and biocompatibility. PeriSeal™ will readily support tissue ingrowth and allow remodeling of the implant site.

Warnings

- The use of strict asceptic technique is required when implanting PeriSeal™. If an infection develops it must be treated aggressively. Removal of the biomaterial may be required.

- Use of the device in applications that expose the tissue to increased level of microbial flora such as transvaginal techniques increase the risk of microbial contamination of the material.

- Possible adverse reactions to PeriSeal™ include those noted for any tissue implant material.

These include infection, seroma formation, inflammation, adhesions, hematoma and fistula formations.

Contraindications

- PeriSeal™ is intended for veterinary applications only and should not be used for human implant.

- Implantation of PeriSeal™ into an infected operative field should be avoided. Postoperative infection should be aggressively treated at the earliest possible time. Unresolved infections may require the removal of the material.

Shelf Life and Storage

PeriSeal™ should be stored at room temperature. Do not allow the tissue to freeze. PeriSeal™ has a shelf life of three (3) years from date of processing.

Sterility

PeriSeal™ is supplied sterile in a 0.75% phosphate buffered glutaraldehyde solution. Provided that the package has not been compromised the product will remain sterile until the expiration date on the jar has elapsed.

Orientation

No orientation of the tissue is required. The upper and lower surfaces are similarly porous.

Recommended Implant Technique

- Use atraumatic, sterile tools when handling PeriSeal™. When removing the tissue from the packaging solution care must be taken to avoid contact with the edges of the container.

- PeriSeal™ should not be allowed to dry at any time.

- Do not suture closer than 2mm from any edge.

Rinsing

- PeriSeal™ must be rinsed prior to use.

- To rinse PeriSeal™ remove from the original packaging solution. Place PeriSeal™ into a sterile basin and completely submerse in saline solution. Gently swirl the solution for a period of five minutes and then discard the solution. Do not allow the tissue to dry out at any time.

Trimming

Trimming PeriSeal™ to size is readily accomplished using standard, sharp surgical instruments. Proper sizing of the tissue is critical to the surgical outcome. Tissue that is excessively undersized may place undue tension on the suture line causing adjacent tissue failure.

Suturing/stapling

PeriSeal™ should be sutured using taper point, non-absorbable sutures. Cutting edge needles should be avoided for use on PeriSeal™. Use of absorbable sutures may lead to inadequate tissue fixation and product failure. When suturing PeriSeal™, care should be taken to avoid placing the suture line excessively close to the tissue edge. The ratio of suture length in the autologous tissue and PeriSeal™ should be 1:1. Similarly a bite ration of 1:1 should be observed at all times. Staples can be used as an alternative to sutures.

Resterilization

PeriSeal™ cannot be resterilized once it has been removed from its container. Excess tissue remaining post-procedure should be discarded.

Successful use of this product is dependent upon the use of aseptic technique, proper material

preparation and good surgical practices. Avalon Medical Ltd guarantees that reasonable care was taken in the preparation and processing of the PeriSeal™ Tissue Patch. No other warranty, expressed or implied, applies to sale or use of PeriSeal™.

PeriSeal™ is a trademark of Avalon Medical, Ltd.

Distributed by:

Veterinary distributors or contact Avalon Medical Ltd at (888) 289-1890 or www.avalonmed.com.

Avalon Medical Ltd, 1060 Curve Crest Blvd, Suite 102, Stillwater, MN 55082

Toll Free: 888.289.1890

Fax: 651.204.5089

info@avalonmed.com

www.avalonmed.com

Presentation:

PeriSeal™ is available in three convenient sizes: 6cm x 8cm patch (#25-01), 8cm x 8 cm patch (#25-02) and 10cm x 10cm patch (#25-03).

rev07.10

NAC No.: 15220000

AVALON MEDICAL LTD.
1060 CURVE CREST BLVD., SUITE 102, STILLWATER, MN, 55082
Toll-Free:   888-289-1890
Fax:   651-204-5089
Website:   www.avalonmed.com
Email:   info@avalonmed.com
Every effort has been made to ensure the accuracy of the PeriSeal Tissue Patch information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-09-05

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