The information contained in this document
is intended for healthcare professionals only.
TissueMend
®
Soft Tissue Repair Matrix
YOUR CHOICE FOR
TENDON AUGMENTATION
Rotator Cuff
Biceps
Quadriceps
Patellar
Achilles
The Biologic Treatment of Choice for
Tendon Augmentation
What is the TissueMend® Soft Tissue Repair Matrix?
The TissueMend® Soft Tissue Repair Matrix is an acellular, collagen
membrane used to repair and reinforce soft tissues where weakness exists.
Composed of pure, non-denatured collagen, the TissueMend® Soft
Tissue Repair Matrix is indicated for tendon repair surgery, including
reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or
other tendons. TissueMend® can be used in both open & arthroscopic
applications.
The TissueMend® scaffold provides a biologic environment to help the
tendon heal and fortify the tissue until it has completed the healing
process.
TissueMend® Product Specification
Composition
Collagen source
Appearance
Color
Size
Pyrogens
Storage conditions
Shelf life
Chemical crosslinkers
Hydration
Native, non-denatured, collagen
Fetal bovine dermis
Flat, dry sheet of uniform thickness and color
White
3 x 3cm, 4 x 4cm, 5 x 6cm, and 6 x 10cm
Non-Pyrogenic
Room temperature
3 years
None
Less than one minute
1
Collagen Scaffold
The human body uses collagen fibers as the predominant building
material for tissue and organs. The collagen fibers serve as the scaffold
within which cells grow, mature, and form new tissue.
»
The collagen fibers that
make up the TissueMend®
Soft Tissue Repair Matrix
are not altered by artificial
crosslinking.
»
As a result of TissueMend®
patented production process,
all cells and cell components
are removed from the source
tissue while preserving the
collagen fiber structure.
»
The acellular collagen
fibers of the TissueMend®
Soft Tissue Repair Matrix
are composed primarily
of Type I and Type III
collagen fibers.
Fetal Collagen
The source material used to produce TissueMend® is fetal bovine dermis. Studies in fetal wound healing have
demonstrated that fetal skin has remarkable regenerative capacities.1 Furthermore, fetal dermis contains minimal
hair and hair follicles, which can cause imperfections in collagen structure.
1
Longaker, M.T.; Whitby, D.J.; Adzick, N.S.; Crombleholme, et al. Studies in Fetal Wound Healing, VI, Second and early third trimester fetal wounds demonstrate
rapid collagen deposition without scar formation. J. Pediatric Surgery, 25: 63-68, 1990.
2
TissueMend®
Soft Tissue Repair Matrix
Biocompatibility
The technologically advanced production process results in a highly biocompatible
implant. In standard biocompatibility assays, the TissueMend® Soft Tissue Repair
Matrix has been classified as a non-irritant.1
Biological Response
When implanted, TissueMend® provides an environment that host cells and
supporting vasculature can take up residence and mature. Over time, normal tissue
remodeling occurs where TissueMend® is incorporated into the native tissue and
ultimately replaced by natural, healthy, native cells and tissue.
Host fibroblasts have migrated
into and populated TissueMend®
beginning the remodeling process.
Note the lack of foreign body
reaction to TissueMend®.
Inflammatory cells are absent
and the implant has not been
encapsulated.
Three month rat intramuscular biocompatibility evaluation.
1. Data on file, TEI Biosciences Inc.
3
Study Model
Species/Strain
Sprague-Dawley rat
Surgical model
Soft Tissue Repair Model
Incision was made along the abdominal midline of each animal
TissueMend®, extending approximately 1.5cm beyond the wound, was sutured into
place along the perimeter of the implant to the underlying musculature
Time points
3 weeks
9 months
15 months
Endpoints
New tissue development
Implant remodeling
Foreign body response
Surgical adhesions
Study Results1
Endpoint
Result
New tissue development
A strong, robust connective tissue developed at the site of the soft tissue defect
repaired with TissueMend®. The implant served as a scaffold upon and within
which a new tissue developed. By 9 months, TissueMend® had been replaced by
new, reparative tissue evident at both 9 and 15 months post-implantation.
Implant remodeling
Acute (3 week) explants showed no gross evidence of remodeling. Histological
examination revealed TissueMend® had been infiltrated with host cells and blood
vessels. A new tissue layer was seen forming on the surface of the implant.
Long-term (9 and 15 month) explants from all animals revealed that TissueMend®
had been remodeled into new, functional, host tissue.
Foreign body response
No evidence of a foreign body response in any animal at any time point.
Surgical adhesions
No surgical adhesions were observed to TissueMend®.
1. Data on file, TEI Biosciences Inc.
4
TissueMend®
Soft Tissue Repair Matrix
Early Histology
Histologic analysis of TissueMend®
reveals incorporation of the implant.
The matrix has been populated with
host cells and blood vessels. New
tissue is seen overgrowing the
implant.
Figure 1
3 week rodent model1
Final Histology
• 15 month histology illustrates
complete remodeling of
TissueMend® implant.
• Fiber orientation has transformed
from the random assembly seen in
Figure 1 to the highly organized,
parallel fibers seen in Figure 2.
Figure 2
• New tissue has completely
integrated with host collagen at
the margin of the original defect.
15 month rodent model1
Physical Appearance
Explanted TissueMend® implant has
been remodeled and replaced by
robust host connective tissue. The
soft tissue defect is reinforced and
repaired.
Figure 3
9 month rodent model1
1. Data on file, TEI Biosciences Inc.
5
Safety
TissueMend® has undergone and passed a thorough biocompatibility assessment conducted by an independent laboratory.1
TissueMend® ISO10993 Safety Profile
Test
Test Method
Result
Genotoxicity
ISO10993-3
non-mutagenic
Hemolysis
ISO10993-4
non-hemolytic
Cytotoxicity
ISO10993-5
no evidence of causing cell lysis or toxicity
Implantation
ISO10993-6
non-irritant
Intracutaneous Reactivity
ISO10993-10
no evidence of significant irritation
Sensitization
ISO10993-10
no evidence of causing delayed dermal contact sensitization
Acute Systemic Toxicity
ISO10993-11
no mortality or evidence of systemic toxicity
Per regulatory requirements, the TissueMend® manufacturing process has been rigorously validated to assure
product sterility and the inactivation of any potentially contaminating viruses. The source material has been
certified safe against the possibility of transmitting infectious transmissible spongiform encephalopathies.2
Sterility
Viral Inactivation
Transmissible Spongiform Encephalopathies
Methods:
Methods:
Methods:
Validated terminal sterilization
process
Validated viral chemical
inactivation manufacturing step
assures inactivation of potentially
contaminated virus classes
• Enveloped RNA virus
• Enveloped DNA virus
• Non-enveloped RNA virus
• Non-enveloped DNA virus
Sourcing from fetal bovine dermis
Results:
Results:
Results:
Sterility assurance level (SAL) 10-6
Validated >6 log10 of viral
reduction and clearance
No detectable TSE infectivity in fetal tissue3
Inspected and certified collection facilities
No detectable TSE infectivity in dermis3
European Directorate for the Quality of
Medicines (EDQM) TSE Safety Certificate
R0-CEP 2004-116-Rev 00
1. Data on file, TEI Biosciences Inc.
2. European Directorate for the Quality of Medicines (EDQM) TSE safety Certificate R0-CEP 2004-116-Rev 00
3. Report of a WHO Consultation on Medical and Other Products in Relation to Human and Animal Transmissible Spongiform Encephalopathies - With the Participation
of the Office International des Epizooties (OIE) - Geneva, Switzerland, 24-16 March 1997.
6
TissueMend®
Soft Tissue Repair Matrix
Indications:
TissueMend® is intended for
reinforcement of soft tissues
repaired by sutures or suture
anchors during tendon repair
surgery, including reinforcement of
the rotator cuff, patellar, Achilles,
biceps, quadriceps, or other tendon.
TissueMend® was developed to
overcome the challenges of tendon
augmentation surgery.
Factors such as poor tissue quality
and insufficient tendon length have
created a need for physical and
biologic tendon augmentation.
Rotator Cuff
Biceps
Quadriceps
Patellar
By combining physical properties of
strength and thickness with
biological properties that encourage
cell and blood vessel penetration, the
TissueMend® collagen matrix is
designed to handle the demands of
soft tissue repair.
Achilles
7
Strength and Handling
TissueMend®
#2, non-resorbable suture
single stitch, mattress technique
Strength and Thickness:
• TissueMend® is composed of a single
layer of nondenatured collagen fibers.
• TissueMend® is nominally 1mm thick.
10 lb weight
• Suture pull out strength of
TissueMend®: 35.5 N.1
Hydration
The TissueMend® collagen matrix hydrates in only seconds, thus reducing
wait time and enhancing efficiency in the operating room.
Non-hydrated
Hydrated
Hydrated
Storage
TissueMend® does not require refrigeration. TissueMend® may be stored on the shelves of any hospital or operating
room for up to 3 years.1
1. Data on file, TEI Biosciences Inc.
8
TissueMend®
Soft Tissue Repair Matrix
What is TissueMend®?
• The TissueMend® Soft Tissue Repair Matrix is an acellular, collagen
membrane used to reinforce soft tissues where weakness exists.
• TissueMend® is composed of pure, non-denatured collagen and is for
augmentation of tendon repair surgery.
How does TissueMend® work?
• For today's challenging tendon repair surgery, surgeons need a strong,
suturable, collagen fiber scaffold to augment the repair both physically
and biologically.
• Like a soft tissue autograft or allograft, TissueMend® is specifically
designed to serve as a scaffold for cellular and vascular ingrowth that
is gradually remodeled into new tissue.
What features does TissueMend® display?
• Strength: 20.0 MPa
• Suture Pull Out: 35.5 N
• Handling & Physical Characteristics: Allows both open &
arthroscopic applications
• Hydration: Less than 1 minute
• Storage: Room temperature
• Shelf Life: 3 years
9
Joint Replacements
Joint Replacements
Trauma
Trauma
Craniomaxillofacial
Craniomaxillofacial
Spine
Spine
Orthobiologics
Orthobiologics
Instruments
Instruments
Interventional Pain
Interventional Pain
Navigation
Navigation
Endoscopy
Endoscopy
Communications
Communications
Imaging
Imaging
Patient Handling Equipment
Patient Handling Equipment
EMS Equipment
EMS Equipment
325 Corporate Drive
Mahwah, NJ 07430
t: 201 831 5000
www.stryker.com
The information presented in this brochure is intended to demonstrate the breadth of Stryker product offerings. Always refer
to the package insert, product label and/or user instructions before using any Stryker product. Surgeons must always rely on
their own clinical judgment when deciding which treatments and procedures to use with patients. Products may not be
available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets.
Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.
Products referenced with TM designation are trademarks of Stryker.
Products referenced with ® designation are registered trademarks of Stryker.
TissueMend is a registered trademark of TEI Biosciences Inc.
Literature Number: LTMEIB
MS/GS 3m 01/06
Copyright © 2006 Stryker
Printed in USA