product summary integra surgimend prs · 606-004-100 10 x 15 cm fenestrated semi-oval 1 mm...

Product Summary

Because we are committed to limiting uncertainty, SurgiMend PRS was designed to minimize the risk of triggering a detrimental foreign body inflammatory response upon implantation.

Integra®

SurgiMend® PRSCollagen Matrix for Plastic &Reconstructive Surgery

Integra® SurgiMend® PRSCollagen Matrix for Plastic & Reconstructive Surgery

A sterile biologic matrix for plastic & reconstructive surgery, derived from fetal bovine dermis, rich in Type III collagen

Rapid revascularization for tissue building and support4

Intraoperatively, patient tissue-building cells and growth factors are sequestered within SurgiMend. The microporous matrix is rapidly revascularized to support tissue building and healing. Rapid cell repopulation and revascularization, combined with SurgiMend PRS’ non-inflammatory nature, provides for prolonged reinforcement.5

All-natural collagen matrixSurgiMend® PRS is the optimal acellular biologic matrix designed specifically for plastic and reconstructive surgery. It is derived from fetal bovine dermis, one of the richest sources of Type III collagen available. Type III collagen has been demonstrated to mediate tissue healing and regrowth while inhibiting scarring.1,2

SurgiMend PRS is made of Type I and Type III healing collagen; and is without preservatives, denatured proteins, artificial chemical crosslinks, cells, lipids, carbohydrates and other constituents, all of which can induce inflammation. It is terminally sterilized – never treated with potentially antigenic antibiotics. As a result, SurgiMend PRS does not elicit a detrimental foreign body inflammatory response upon implantation.3

SurgiMend PRS rehydrates in minutes, is easy to handle and place, and is designed with fenestrations to facilitate fluid drainage. It is available in multiple unique shapes and sizes.

1. Larson et al. Scarless fetal wound healing: a basic science review. Plast Reconstr Surg. 2010;126:1172-1180.2. Volk et al. Diminished type III collagen promotes myofibroblast differentiation and increases scar deposition in cutaneous wound healing. Cells Tissues Organs. 2011;194:25-37.3. Cornwell K, Landsman A, James K. Extracellular matrix biomaterials for soft tissue repair. Clin Podiatr Med Surg. 2009 Oct; 26(4):507-23.4. Adelman D, Cornwell K. Analysis of adherence and vascularization patterns of bioprosthetic mesh compared to synthetic mesh in a rat intra-abdominal implant model. Presented at:Abdominal Wall Reconstruction Conference; 2014 Jun 12-14; Washington, DC.5. Adelman D. Radiographic evaluation of biologic mesh repair in ventral abdominal herniorrhaphy. Presented at: American College of Surgeons Clinical Congress; 2013 Oct 6-10; Washington, DC.6. Cornwell, K, Zhang F, Lineaweaver W. Bovine fetal collagen reinforcement in a small animal model of hernia with component repair. Journal of Surgical Research. 2015 Nov; 0(0)

Composition Native, non-denatured collagen

Collagen source Bovine dermis

Appearance Flat, dry sheet of uniform thickness and color

Thickness 1 mm* and 0.6 mm* product available

Storage Room temperature storage

Chemical crosslinkers None

Rehydration Approximately 60 seconds in room temperature saline†

Intraoperative handling Can be trimmed to size wet or dry and placed in any orientation, with either side up

Pyrogen and viral safety Non-pyrogenic; manufacturing process includes validated viral-inactivation steps

Transmissible SpongiformEncephalopathy (TSE) safety

TSE safety certification by European Directorate for the Quality of Medicines; source tissue selected and processed in accordance with strict US and International regulatory requirements

Sterilization Via exposure to ethylene oxide gas; sterility assurance level of 10-6 with undetectable ethylene oxide residuals

IndicationsSurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged orruptured soft tissue membranes. SurgiMend is specifically indicated for:• Plastic and reconstructive surgery• Muscle Flap Reinforcement• Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.

Contraindications• Product is not designed, sold, or intended for use except as indicated.• Product should not be used in patients with a known history of hypersensitivity to collagen or bovine products.

Potential ComplicationsGeneral risks may include, but are not limited to: infection, allergic reactions, pain, swelling or bruising, foreign bodyreactions, acute or chronic inflammatory reactions, adhesions, seromas, hematomas, and repair laxity. The patientshould be made aware of these risks and others associated with general surgery and the use of anesthesia.

Ordering Information

Reference Description Thickness*

606-004-110 6 x 16 cm Fenestrated Semi-Oval 1 mm

606-004-101 7 x 17 cm Fenestrated Rectangle 1 mm



606-004-108 8 x 16 cm Fenestrated Semi-Oval (Thin) 0.6 mm



606-004-106 10 x 15 cm Fenestrated Semi-Oval Slanted 1 mm


606-004-109 10 x 20 cm Fenestrated Rectangle (Thin) 0.6 mm


*Nominal†SurgiMend PRS is specified to hydrate in ≤ 3 minutes; typically, it hydrates in ~60 seconds.

SurgiMend PRS

• An acellular collagen matrix derived from fetal bovine dermis rich in Type III collagen

• Provides sound structural support

• Collagen matrix with no preservatives, denatured proteins, cells, lipids, carbohydrates, antibiotics and other constituents, all of which can induce inflammation.

• No artificial/chemical crosslinking

• Terminally sterilized (10-6 SAL), safe & consistent

• Rapid revascularization without detrimental inflammation for prolonged reinforcement1,2,6

• Fenestrated to help drain fluids

• Multiple unique sizes and shapes

• Optimal handling characteristics and minimal preparation time – rehydrates in minutes

• Room temperature storage, five-year shelf life

United States, Canada, Asia, Pacific, Latin America

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region. n Always refer to the appropriate instructions for use for complete clinical instructions.n Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.n Warning: Applicable laws restrict these products to sale by or on the order of a physician.

For more information or to place an order, please contact:

USA 866-524-0022 n 888-623-2259 faxInternational +1 617-268-1616 n + 1 617-268-3282 [email protected]

SurgiMend, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. ©2016 Integra LifeSciences Corporation. All rights reserved. Printed in USA. 5 M 0438605-2-EN

Integra® SurgiMend® PRSCollagen Matrix for Plastic & Reconstructive Surgery

TEI Biosciences, a subsidiary of Integra LifeSciences Corporation 7 Elkins StreetBoston, MA 02127 n USA

Manufacturer:

product summary integra surgimend prs · 606-004-100 10 x 15 cm fenestrated semi-oval 1 mm...

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