GORE BIO-A Tissue Reinforcement

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5 Νοε 2013 (πριν από 3 χρόνια και 5 μήνες)

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Products listed may not be available in all markets.

GORE
®
, BIO
-
A
®
, and designs are trademarks of W. L. Gore & Associates.

©
2010 W.L. Gore & Associates, Inc. AP6305
-
EN1 NOVEMBER 2010

GORE
®

BIO
-
A
®

Tissue Reinforcement

A Valuable Alternative to Biologics

Refer to Instructions For Use at goremedical.com for a complete description of all
warnings, precautions, and adverse events.

Products listed may not be available in all markets.

GORE
®
, BIO
-
A
®
, and designs are trademarks of W. L. Gore & Associates.

©
2010 W.L. Gore & Associates, Inc. AP6305
-
EN1 NOVEMBER 2010

Clinical need

Additional support for tissue without increased
risks associated with permanent materials
1,2

What are the risks?

• Erosion

• Infection

• Seroma

• Wound dehiscence

• Enterocutaneous fistulae

1
Davis SS Jr. Current controversies in paraesophageal hernia repair.
Surgical Clinics of North America
2008;88(5);959
-
978.

2
Bruening K, Butler CE, Ferzoco S,
et al
; The Ventral Hernia Working Group. incisional ventral hernias; review of the literature

and recommendations regarding the grading and technique of repair.
Surgery
2010;148(3);544
-
558.


Products listed may not be available in all markets.

GORE
®
, BIO
-
A
®
, and designs are trademarks of W. L. Gore & Associates.

©
2010 W.L. Gore & Associates, Inc. AP6305
-
EN1 NOVEMBER 2010

solution

Reinforcement material that functions as a scaffold for
patient’s own cells to create tissue and replace material
over time, leaving no permanent mesh behind.

Two options:


Harvest human or animal tissue and remove cells to
leave scaffold behind


Biologics


NEW ALTERNATIVE:

Create synthetic tissue scaffold


Bioabsorbable web

Products listed may not be available in all markets.

GORE
®
, BIO
-
A
®
, and designs are trademarks of W. L. Gore & Associates.

©
2010 W.L. Gore & Associates, Inc. AP6305
-
EN1 NOVEMBER 2010

Managing the risk of complications

in complex cases

In the example of incisional hernia repair, many cases are complex. As Breuing
et

al
1
states,
numerous influences that vary from patient to patient increase the risk of complications such as
infections, seroma, wound dehiscence, formation of enterocutaneous fistulae and recurrence, as
depicted below.

Risk Assessment


Low risk of
complications


No history of
wound infections

Co
-
morbid


Smoker


Obese


Diabetic


Immunosuppressed


COPD

Potentially
Contaminated


Previous wound
infection


Stoma present


Violation of the
gastrointestinal tract

Infected


Infected mesh


Septic dehiscence

1
Breuing K, Butler CE, Ferzoco S,
et al
; The Ventral Hernia Working Group. Incisional ventral hernais: review of the literature
and recommendations regarding the grading and technique of repair.
Surgery

2010;148(3):544
-
558.

Products listed may not be available in all markets.

GORE
®
, BIO
-
A
®
, and designs are trademarks of W. L. Gore & Associates.

©
2010 W.L. Gore & Associates, Inc. AP6305
-
EN1 NOVEMBER 2010

Bioabsorbable scaffold designed to

facilitate tissue generation

Uniquely designed web of bioabsorbable polymers

• 67% PGA : 33% TMC



Same polymer as Maxon™ Suture

• Highly interconnected pores

• Degrades primarily by hydrolysis


3D matrix facilitates tissue generation

and healing

• Cells infiltrate and form vascularized


soft tissue

• Scaffold is absorbed in approximately six months

Maxon is a trademark of Covidien AG or its affiliates
.

Products listed may not be available in all markets.

GORE
®
, BIO
-
A
®
, and designs are trademarks of W. L. Gore & Associates.

©
2010 W.L. Gore & Associates, Inc. AP6305
-
EN1 NOVEMBER 2010

Tissue scaffold


Material Structure

1
Photo courtesy of Biophysical Society and Christopher B. Raub, Vinod Suresh,

Tatiana Krasieva, Julia Lyubovitsky, Justin D. Mih, Andrew J. Putnam,

Bruce J. Tromberg, and Steven C. George

University of California Irvine

GORE
®

BIO
-
A
®

Tissue Reinforcement SEM
(100x)

GORE
®

BIO
-
A
®

Tissue Reinforcement SEM (50x)

3D Matrix with Highly Interconnected Pores

Bioabsorbable web
structure similar to a
collagen fiber network

Collagen Gel
1

Products listed may not be available in all markets.

GORE
®
, BIO
-
A
®
, and designs are trademarks of W. L. Gore & Associates.

©
2010 W.L. Gore & Associates, Inc. AP6305
-
EN1 NOVEMBER 2010

Gore bioabsorbable technology

3D bioabsorbable
scaffold implanted

Cells migrate into
scaffold

Cells secrete collagen to
create new tissue

Material absorbs and cells fill
space with new tissue

Products listed may not be available in all markets.

GORE
®
, BIO
-
A
®
, and designs are trademarks of W. L. Gore & Associates.

©
2010 W.L. Gore & Associates, Inc. AP6305
-
EN1 NOVEMBER 2010

Tissue Fills the scaffold

*Cells & Blood Vessels Make Up Remaining Volume

Calculated by Histological Image
Analysis

1
Morales
-
Conde S, Flores M, Fernandez V, Morales
-
Mendez S. Bioabsorbable vs polypropylene plug for the “mesh and Plug” inguinal
hernia repair. Poster presented at the 9th Annual Meeting of the American Hernia Society; February 9
-
12, 2005; San Diego, CA.

Volume of Material = Volume of Tissue:

1:1 Replacement
1

Products listed may not be available in all markets.

GORE
®
, BIO
-
A
®
, and designs are trademarks of W. L. Gore & Associates.

©
2010 W.L. Gore & Associates, Inc. AP6305
-
EN1 NOVEMBER 2010

Tissue scaffold


Rapid cell population and vascularization
1

3 Days:

7 Days:

14 Days:

30 Days:

As early as three
days, the material is
firmly embedded into
native tissue (arrow).
Cellular infiltration is
present with
lymphocytes,
macrophages and
erythrocytes.

As wound healing
progresses, strands
of collagen and
capillary proliferation
(arrows) are evident.

Dense
fibrocollagenous tissue
forms an early cellular
scaffold as the
material starts to
absorb. Blood vessels
are present between
the material fibers.

Native tissue is
seamlessly incorporated
within the GORE
®
BIO
-
A
®
Material.

1

Milligan’s Trichrome 20x. Histology of abdominal wall explant in rabbit. Data on file.

Products listed may not be available in all markets.

GORE
®
, BIO
-
A
®
, and designs are trademarks of W. L. Gore & Associates.

©
2010 W.L. Gore & Associates, Inc. AP6305
-
EN1 NOVEMBER 2010

Versatile for numerous applications

Onlay of GORE
®

BIO
-
A
®

Tissue
Reinforcement following primary
closure of cura

Suture line reinforcement with
GORE
®

BIO
-
A
®

Tissue
Reinforcement following midline
closure

Reinforcement of the pelvic floor
with GORE
®

BIO
-
A
®

Tissue
Reinforcement following primary
closure

GORE
®

BIO
-
A
®

Tissue
Reinforcement placed between
anterior sheath and rectus muscle
prior to primary closure of anterior
sheath

Reinforcement of suture line with
GORE
®

BIO
-
A
®

Tissue
Reinforcement at rectus muscle
donor site

Paraesophageal/hiatal
hernia repair

Abdominal wall
reconstruction

Abdominoperineal
resection

Stoma reversal

Breast reconstruction
using pedicled TRAM
flap

Products listed may not be available in all markets.

GORE
®
, BIO
-
A
®
, and designs are trademarks of W. L. Gore & Associates.

©
2010 W.L. Gore & Associates, Inc. AP6305
-
EN1 NOVEMBER 2010

A new alternative to expensive biologics

GORE
®
BIO
-
A
®

Tissue Reinforcement is intended for use in the reinforcement
of soft tissue. Example applications where this product may be used include,
but are not limited to:



Hernia repair (non
-
load bearing applications)



Muscle flap reinforcement



General tissue reconstructions


Products listed may not be available in all markets.

GORE
®
, BIO
-
A
®
, and designs are trademarks of W. L. Gore & Associates.

©
2010 W.L. Gore & Associates, Inc. AP6305
-
EN1 NOVEMBER 2010

Conclusion


Non
-
permanent tissue scaffolds play an
important clinical role


Biologics (decellularized tissue) are not the only
technology to provide tissue scaffolds


Gore bioabsorbable web technology creates
tissue scaffold without disadvantages of
permanent materials or biologics

Products listed may not be available in all markets.

GORE
®
, BIO
-
A
®
, and designs are trademarks of W. L. Gore & Associates.

©
2010 W.L. Gore & Associates, Inc. AP6305
-
EN1 NOVEMBER 2010

GORE
®
BIO
-
A
®

Tissue Reinforcement

Images

Products listed may not be available in all markets.

GORE
®
, BIO
-
A
®
, and designs are trademarks of W. L. Gore & Associates.

©
2010 W.L. Gore & Associates, Inc. AP6305
-
EN1 NOVEMBER 2010

Product Photos

Products listed may not be available in all markets.

GORE
®
, BIO
-
A
®
, and designs are trademarks of W. L. Gore & Associates.

©
2010 W.L. Gore & Associates, Inc. AP6305
-
EN1 NOVEMBER 2010

Product Photos

Products listed may not be available in all markets.

GORE
®
, BIO
-
A
®
, and designs are trademarks of W. L. Gore & Associates.

©
2010 W.L. Gore & Associates, Inc. AP6305
-
EN1 NOVEMBER 2010

Gore bioabsorbable clinical history