Transcript Rough Draft - Gore Medical

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 materials1,2
What are the risks?
• Erosion
• Infection
• Seroma
• Wound dehiscence
• Enterocutaneous fistulae
1Davis
SS Jr. Current controversies in paraesophageal hernia repair. Surgical Clinics of North America 2008;88(5);959-978.
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.
2Bruening
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 al1 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
1Breuing
Potentially
Contaminated
• Previous wound
infection
• Stoma present
• Violation of the
gastrointestinal tract
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
Infected
• Infected mesh
• Septic dehiscence
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
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
1Photo
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
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
Collagen Gel1
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
Volume of Material = Volume of Tissue:
1:1 Replacement1
*Cells & Blood Vessels Make Up Remaining Volume
Calculated by Histological Image
Analysis
Morales-Conde S, Flores M, Fernandez V, Morales-Mendez S. Bioabsorbable vs polypropylene plug for the “mesh and Plug” inguinal
1
hernia repair. Poster presented at the 9th Annual Meeting of the American Hernia Society; February 9-12, 2005; San Diego, CA.
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 vascularization1
3 Days:
As early as three
days, the material is
firmly embedded into
native tissue (arrow).
Cellular infiltration is
present with
lymphocytes,
macrophages and
erythrocytes.
1
7 Days:
As wound healing
progresses, strands
of collagen and
capillary proliferation
(arrows) are evident.
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
14 Days:
Dense
fibrocollagenous tissue
forms an early cellular
scaffold as the
material starts to
absorb. Blood vessels
are present between
the material fibers.
30 Days:
Native tissue is
seamlessly incorporated
within the GORE® BIOA® Material.
Versatile for numerous applications
Abdominal wall
reconstruction
Paraesophageal/hiatal
hernia repair
Onlay of GORE® BIO-A® Tissue
Reinforcement following primary
closure of cura
Suture line reinforcement with
GORE® BIO-A® Tissue
Reinforcement following midline
closure
Breast reconstruction
using pedicled TRAM
flap
Stoma reversal
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
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
Abdominoperineal
resection
Reinforcement of the pelvic floor
with GORE® BIO-A® Tissue
Reinforcement following primary
closure
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
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