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

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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

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A proven technology.

With over 1,200 total published articles, Biodesign is

one of the most well-studied graft technologies on the
market.

1265
Published articles

436
Describing use
in humans
15Published
OHNS studies

7
> 5 year
20
Randomized
follow-up 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. Otolaryn-
gol 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_Ab-
stracts_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.
• Lalwani, Anil K. (2003, May). “Surgisis for Repair of Tympanic membrane
Perforation.” Poster presented at the meeting of the Combined Otolaryn-
gological Spring Meetings, Nashville, TN.
• 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.
• 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.
• 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):528-
529.
• 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 cerebro-
spinal fluid leak repair. Int Forum Allergy Rhinol. 2012;2(3):227-232.
• 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.
• Chaaban MR, Conger B, Riley KO, et al. Transnasal endoscopic repair of poste-
rior table fractures. Otolaryngol Head Neck Surg. 2012;147(6):1142-1147.
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 Published history
of therapeutic uses.
The technology behind Biodesign has been used
in numerous applications throughout the body.
Eyelid reconstruction

Dural substitute
Sinonasal repair

Tympanoplasty
Facial reconstruction

Periodontal graft
Carotid patch

Cied pouches
Pericardial repair

Staple line reinforcement

Hiatal hernia

Management of second degree burns

Peripheral nerve repair

Enterocutaneous fistula
Parastomal reinforcement

Inguinal hernia
Ventral hernia

Rectovaginal fistula
Rectal prolapse

Anal fistula
Peyronie's repair

Venous ulcers
Pressure ulcers

Diabetic 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

4 -L AYE R T IS SU E GR AFT
HIATA L HE R N I A GR A FT STAPLE LIN E
R E IN FOR C EME N T OTOLOGI C REPAI R
GRAFT

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BIODESIGN PRODUCTS
FOR OTOLARYNGOLOGY.
Illustration by Lisa Clark.

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OTOLOGIC REPAIR

Harvest results,
not patient tissue.

Illustration by Lisa Clark.

 Biodesign® Otologic Repair Graft
The Biodesign Otologic Repair Graft is a dependable, easy-
to-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 Reference Size

Number Part Number cm

G44451 ENT-OTO-2.5X2.5 2.5 x 2.5

G44452 ENT-OTO-5X5 5x5
G44840 ENT-OTO-0.4-0.6 0.4, 0.6
G44839 ENT-OTO-0.6-0.9 0.6, 0.9
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 Reference Size

Number Part Number 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 Reference Size

Number Part Number 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.

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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 Reference Size

Number Part Number cm

G34977 ENT-CBD-1X2 1x2

G34978 ENT-CBD-2.5X2.5 2.5 x 2.5
G34979 ENT-CBD-5X5 5x5
G34980 ENT-CBD-7X8.5 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

Order Reference Size

Number Part Number cm

G44451 ENT-OTO-2.5X2.5 2.5x2.5

G44452 ENT-OTO-5X5 5x5
G44840 ENT-OTO-0.4-0.6 0.4, 0.6
G44839 ENT-OTO-0.6-0.9 0.6, 0.9
Some products or part numbers may not be available in all markets. Contact your local Cook
page 13 representative or Customer Service for details.

Biodesign® Sinonasal Repair Graft

Order Reference Size

Number Part Number 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
page 15 representative or Customer Service for details.
 Biodesign® Dural Repair Graft

Order Reference Size

Number Part Number 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
page 17 representative or Customer Service for details.

Biodesign® Duraplasty Graft

Order Reference Size

Number Part Number cm

G34977 ENT-CBD-1X2 1X2

G34978 ENT-CBD-2.5X2.5 2.5X2.5
G34979 ENT-CBD-5X5 5X5
G34980 ENT-CBD-7X8.5 7X8.5
Some products or part numbers may not be available in all markets. Contact your local Cook
page 19 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

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