Products for
SOFT TISSUE
REPAIR
BIODESIGN
®
A D V A N C E D T I S S U E R E PA I R
TECHNOLOGY
Advance to the
next generation of
biologic grafts.
Illustration by Lisa Clark.
What is Biodesign?
Biodesign is a platform technology
behind numerous tissue repair
products that span multiple medical
specialties.
Biodesign is natural extracellular
matrix (ECM) derived from porcine
small intestinal submucosa (SIS).
The ECM is a complex latticework of
proteins and signaling factors that
helps guide the growth of cells.
Cook’s proprietary processing
methodology decellularizes the
SIS material while preserving
natural matrix molecules such
as collagen, proteoglycans, and
glycosaminoglycans.
The result is a scaffold that, when
implanted, provides a location for
host cells to infiltrate and remodel
into well-vascularized tissue.
3
Why Porcine SIS?
Why pigs?
Pigs are a readily available source.
This allows for tight control over the
age, weight, and medical history of
the source animal.
There is no documented TSE
transmission between pigs and
humans.
Material from pigs has been proven
to be safe for medical devices.
Why SIS?
The submucosa within the small
intestine survives one of the harshest
environments of the body and
supports rapid cell turnover.
SIS’s complex composition makes
it an ideal candidate for soft tissue
repair.
How does Biodesign work?
There are three essential
components to healing: a scaffold,
signals, and cells.
Biodesign’s open lattice structure
provides a scaffold for tissue
ingrowth.
The body's signaling mechanisms
help patient cells infiltrate the
scaffold and completely remodel into
natural host tissue.
x40 mag.
Biodesign graft prior to implantation
SCAFFOLD
SIGNALS
CELLS
x40 mag.
8 months after implantation
5
What is the result?
The result is a durable repair
consisting of well-vascularized tissue.
Placement of a Biodesign graft
15 days post-op
40 days post-op
60 days post-op
Images of endoscopic tympanoplasty provided by Dott. Giuseppe
Panetti, December 2014, Ascalesi Hospital-ASL Napoli
7
A proven technology.
With over 1,200 total published articles, Biodesign is
one of the most well-studied graft technologies on the
market.
436
15
7
20
1265
Published articles
Describing use
in humans
> 5 year
follow-up
Published
OHNS studies
Randomized
controlled trials
Data and resources
•
Alexander NS, Chaaban MR, Riley KO, et al. Treatment strategies for lateral
sphenoid sinus recess cerebrospinal fluid leaks. Arch Otolaryngol Head
Neck Surg. 2012;138(5):471-478.
•
D'Eredita R. SurgisSiS myringoplasty: a 10-year study in children. Otolaryngol Head Neck Surg. 2012;147(suppl 2):104-105. http://oto.sagepub.com/
content/suppl/2012/08/22/147.2_suppl.DC1/2012_Official_Program_Abstracts_low_res.pdf. Accessed September 2, 2016.
•
Spiegel JH, Kessler JL. Tympanic membrane perforation repair with
acellular porcine submucosa. Otology & Neurotology, Vol. 26, No. 4, pgs
563-566 2005.
•
Greywoode J, Hamilton J, Malhotra PS, et al. Repair of nasal septal perforation
with porcine small intestinal submucosa xenograft. J Otol Rhinol. 2012;1:(2).
•
Ambro BT, Zimmerman J, Rosenthal M, et al. Nasal septal perforation repair
with porcine small intestinal submucosa. Arch Facial Plast Surg. 2003;5(6):528529.
•
Bejjani GK, Zabramski J; Durasis Study Group. Safety and efficacy of the
porcine small intestinal submucosa dural substitute: results of a prospective
multicenter study and literature review. J Neurosurg. 2007;106(6):1028-1033.
•
Jones V, Virgin F, Riley K, et al. Changing paradigms in frontal sinus cerebrospinal fluid leak repair. Int Forum Allergy Rhinol. 2012;2(3):227-232.
•
Lalwani, Anil K. (2003, May). “Surgisis for Repair of Tympanic membrane
Perforation.” Poster presented at the meeting of the Combined Otolaryngological Spring Meetings, Nashville, TN.
•
Blount A, Riley K, Cure J, et al. Cerebrospinal fluid volume replacement
following large endoscopic anterior cranial base resection. Int Forum Allergy
Rhinol. 2012;2(3):217-221.
•
Ofo E, Singh A, Liyanage S, Kalan A, “Tympanic Membrane Perforation
Repair With Acellular Porcine Small Intestinal Submucosa (Surgisis®): Is It
Time To Replace Temporalis Fascia?” North West London Hospitals NHS.
•
Chaaban MR, Conger B, Riley KO, et al. Transnasal endoscopic repair of posterior table fractures. Otolaryngol Head Neck Surg. 2012;147(6):1142-1147.
•
Illing E, Chaaban MR, Riley KO, et al. Porcine small intestine submucosal
graft for endoscopic skull base reconstruction. Int Forum Allergy Rhinol.
2013;3(11):928-932.
9
Published history
of therapeutic uses.
The technology behind Biodesign has been used
in numerous applications throughout the body.
Eyelid reconstruction
Dural substitute
Tympanoplasty
Periodontal graft
Cied pouches
Staple line reinforcement
Management of second degree burns
Enterocutaneous fistula
Inguinal hernia
Rectovaginal fistula
Anal fistula
Venous ulcers
Diabetic ulcers
Sinonasal repair
Facial reconstruction
Carotid patch
Pericardial repair
Hiatal hernia
Peripheral nerve repair
Parastomal reinforcement
Ventral hernia
Rectal prolapse
Peyronie's repair
Pressure ulcers
FISTU LA PLU G
P EYRONI E’S
R EPAI R GRAFT
D U RA L G RA F T
H E R N IA GR AFT
N IP P L E RE CO N STR U CTION
CYL IN D E R
I N GU I N A L
H E R N I A GR A FT
FISTULA P LUG
HIATA L HE R N I A GR A FT
4 -L AYE R T IS SU E GR AFT
STAPLE LIN E
R E IN FOR C EME N T
OTOLOGI C REPAI R
GRAFT
11
BIODESIGN PRODUCTS
FOR OTOLARYNGOLOGY.
Illustration by Lisa Clark.
13
OTOLOGIC REPAIR
Harvest results,
not patient tissue.
Illustration by Lisa Clark.
Biodesign® Otologic Repair Graft
The Biodesign Otologic Repair Graft is a dependable, easyto-handle and time-saving graft option to repair the tympanic
membrane, while reducing the need to harvest autologous tissue.
The Biodesign Otologic Repair Graft is intended for use as an
implant material to aid in surgical repairs and as an adjunct to
aid in the natural healing process in various otologic procedures,
including but not limited to myringoplasty and tympanoplasty.
Order
Number
Reference
Part Number
G44451
ENT-OTO-2.5X2.5
G44452
ENT-OTO-5X5
G44840
ENT-OTO-0.4-0.6
0.4, 0.6
G44839
ENT-OTO-0.6-0.9
0.6, 0.9
Size
cm
2.5 x 2.5
5x5
Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details.
15
SINONASAL REPAIR
Restore sinonasal tissue.
Illustration by Lisa Clark.
Biodesign® Sinonasal Repair Graft
The Biodesign Sinonasal Repair Graft is designed specifically to
aid in the body’s natural healing process during nasal and sinus
mucosal tissue procedures.
The Biodesign Sinonasal Repair Graft is intended to separate
tissue or structures compromised by surgical trauma, help control
minimal bleeding, and act as an adjunct to aid in the natural
healing process. The device is indicated for use where an open
wound dressing material is required in the nasal and/or sinus
cavities following nasal and/or sinus surgery where separation of
tissues or structures is desired.
Order
Number
Reference
Part Number
Size
cm
G35947
ENT-TRG-1X2
1x2
G35948
ENT-TRG-2X3
2x3
G35949
ENT-TRG-4X7
4x7
G35950
ENT-TRG-7X10
7 x 10
Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details.
17
DURAL REPAIR
Achieve a watertight
dural seal.
Illustration by Lisa Clark.
Biodesign® Dural Repair Graft
The Biodesign Dural Repair Graft is a nonporous, absorbable,
multi-layer sheet of extracellular collagen matrix derived from
porcine small intestinal submucosa. The graft is nonpyrogenic
and has sufficiently low endotoxin levels to make it suitable for
applications where it will contact cerebrospinal fluid.
The graft is intended for use as dural substitute for the repair of
dura mater.
Order
Number
Reference
Part Number
Size
cm
G32437
C-DUR-2X3
2x3
G31090
C-DUR-4X7
4x7
G31091
C-DUR-7X10
7 x 10
G31092
C-DUR-7X20
7 x 20
Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details.
19
SKULL BASE RECONSTRUCTION
Choose a graft that handles
like native dura mater.
Illustration by Lisa Clark.
Biodesign® Duraplasty Graft
The Biodesign Duraplasty Graft is a nonporous, absorbable,
multi-layer sheet of extracellular collagen matrix derived from
porcine small intestinal submucosa. The graft is nonpyrogenic
and has sufficiently low endotoxin levels to make it suitable for
applications where it will contact cerebrospinal fluid during the
repair of dura mater.
The graft is intended for use as dural substitute for the repair of
dura mater.
Order
Number
Reference
Part Number
G34977
ENT-CBD-1X2
G34978
ENT-CBD-2.5X2.5
G34979
ENT-CBD-5X5
G34980
ENT-CBD-7X8.5
Size
cm
1x2
2.5 x 2.5
5x5
7 x 8.5
Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details.
21
PRODUCT PORTFOLIO
Biodesign® Otologic Repair Graft
page 13
Order
Number
Reference
Part Number
G44451
ENT-OTO-2.5X2.5
G44452
ENT-OTO-5X5
G44840
ENT-OTO-0.4-0.6
0.4, 0.6
G44839
ENT-OTO-0.6-0.9
0.6, 0.9
Size
cm
2.5x2.5
5x5
Some products or part numbers may not be available in all markets. Contact your local Cook
representative or Customer Service for details.
Biodesign® Sinonasal Repair Graft
Order
Number
page 15
Reference
Part Number
Size
cm
G35947
ENT-TRG-1X2
1X2
G35948
ENT-TRG-2X3
2X3
G35949
ENT-TRG-4X7
4X7
G35950
ENT-TRG-7X10
7X10
Some products or part numbers may not be available in all markets. Contact your local Cook
representative or Customer Service for details.
Biodesign® Dural Repair Graft
Order
Number
page 17
Reference
Part Number
Size
cm
G32437
C-DUR-2X3
2X3
G31090
C-DUR-4X7
4X7
G31091
C-DUR-7X10
7X10
G31092
C-DUR-7X20
7X20
Some products or part numbers may not be available in all markets. Contact your local Cook
representative or Customer Service for details.
Biodesign® Duraplasty Graft
Order
Number
page 19
Reference
Part Number
G34977
ENT-CBD-1X2
G34978
ENT-CBD-2.5X2.5
G34979
ENT-CBD-5X5
G34980
ENT-CBD-7X8.5
Size
cm
1X2
2.5X2.5
5X5
7X8.5
Some products or part numbers may not be available in all markets. Contact your local Cook
representative or Customer Service for details.
23
Products for
SOFT
TISSUE
REPAIR
To learn more, visit www.cookmedical.com/otolaryngology
To contact us, visit www.cookmedical.com/connect
www.cookmedical.com
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