Products for SOFT TISSUE REPAIR - Cook Medical · PDF fileBiodesign is a platform technology behind numerous tissue repair products that span multiple medical specialties. Biodesign

SOFT TISSUE REPAIR

Products for

BIODESIGN®

A D VA 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.

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.

What is Biodesign?

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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.

Why Porcine SIS?

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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.

How does Biodesign work?

CELLSSIGNALS

SCAFFOLD

x40 mag.

x40 mag.

Biodesign graft prior to implantation

8 months after implantation

The result is a durable repair consisting of well-vascularized tissue.

What is the result?

Placement of a Biodesign graft 15 days post-op

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40 days post-op 60 days post-op

Images of endoscopic tympanoplasty provided by Dott. Giuseppe Panetti, December 2014, Ascalesi Hospital-ASL Napoli

A proven technology.

1265Published articles 15

Published OHNS studies

436Describing use

in humans

7> 5 year

follow-up

20Randomized

controlled trials

With over 1,200 total published articles, Biodesign is one of the most well-studied graft technologies on the market.

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Data and resources

• 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.

• 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.

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

Eyelid reconstruction

Sinonasal repair

Facial reconstruction

Carotid patch

Pericardial repair

Hiatal hernia

Peripheral nerve repair

Parastomal reinforcement

Ventral hernia

Rectal prolapse

Peyronie's repair

Pressure ulcers

Published history of therapeutic uses.

The technology behind Biodesign has been used in numerous applications throughout the body.

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4-LAYER TISSUE GRAFT

PEYRONIE’S REPAIR GRAFT

STAPLE LINE REINFORCEMENT

NIPPLE RECONSTRUCTION CYLINDER

FISTULA PLUG

DURAL GRAFT

FISTULA PLUG

HERNIA GRAFT

HIATAL HERNIA GRAFT

INGUINAL HERNIA GRAFT

OTOLOGIC REPAIR GRAFT

BIODESIGN PRODUCTS FOR OTOLARYNGOLOGY.

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OTOLOGIC REPAIR

Harvest results, not patient tissue.


Biodesign® Otologic Repair GraftThe 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.

OrderNumber

ReferencePart Number

Size cm

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

G44452 ENT-OTO-5X5 5 x 5

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.

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Restore sinonasal tissue.

SINONASAL REPAIR


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Biodesign® Sinonasal Repair GraftThe 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.

OrderNumber


Size cm

G35947 ENT-TRG-1X2 1 x 2

G35948 ENT-TRG-2X3 2 x 3

G35949 ENT-TRG-4X7 4 x 7

G35950 ENT-TRG-7X10 7 x 10


Achieve a watertight dural seal.

DURAL REPAIR


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Biodesign® Dural Repair GraftThe 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.

OrderNumber


Size cm

G32437 C-DUR-2X3 2 x 3

G31090 C-DUR-4X7 4 x 7

G31091 C-DUR-7X10 7 x 10

G31092 C-DUR-7X20 7 x 20


Choose a graft that handles like native dura mater.

SKULL BASE RECONSTRUCTION


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.

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OrderNumber


Size cm

G34977 ENT-CBD-1X2 1 x 2

G34978 ENT-CBD-2.5X2.5 2.5 x 2.5

G34979 ENT-CBD-5X5 5 x 5

G34980 ENT-CBD-7X8.5 7 x 8.5


PRODUCT PORTFOLIO

Biodesign® Otologic Repair Graft

Biodesign® Sinonasal Repair Graft

OrderNumber


Size 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


OrderNumber


Size cm

G35947 ENT-TRG-1X2 1X2



G35950 ENT-TRG-7X10 7X10


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Biodesign® Dural Repair Graft

Biodesign® Duraplasty Graft

OrderNumber


Size cm

G32437 C-DUR-2X3 2X3

G31090 C-DUR-4X7 4X7

G31091 C-DUR-7X10 7X10

G31092 C-DUR-7X20 7X20


OrderNumber


Size 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 representative or Customer Service for details.page 19

page 17

To learn more, visit www.cookmedical.com/otolaryngology

To contact us, visit www.cookmedical.com/connect

Products for

SOFTTISSUEREPAIR

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Products for SOFT TISSUE REPAIR - Cook Medical · PDF fileBiodesign is a platform technology behind numerous tissue repair products that span multiple medical specialties. Biodesign