Biodesign

Biodesign
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Biodesign

Product catalog summary
Introduction to Biodesign Technology
Biodesign is a platform technology used in various tissue-repair products across multiple medical specialties. It utilizes a natural extracellular matrix (ECM) derived from porcine small intestinal submucosa (SIS), which is a complex structure of proteins and molecules that guide cell growth.

Biodesign Processing Methodology
Cook's proprietary processing method decellularizes the SIS material while preserving essential matrix molecules like collagen, proteoglycans, and glycosaminoglycans. This results in a scaffold that supports host cell infiltration and remodeling into vascularized tissue.

Healing Components and Mechanism
Biodesign involves three key components for healing: a scaffold, signals, and cells. The open lattice structure of Biodesign provides a scaffold for tissue ingrowth, while the body's signaling mechanisms facilitate the infiltration and remodeling of patient cells into natural host tissue.

Clinical Outcomes and Proven Technology
Biodesign has been extensively studied, with over 1,400 published articles as of May 2018. It is used in various applications, including tympanoplasty, periodontal grafts, and hernia repairs, among others. The technology has demonstrated durable repair outcomes with vascularized tissue formation.

Applications and Therapeutic Uses
Biodesign technology is applied in numerous medical procedures, such as dural substitutes, tympanoplasty, periodontal grafts, and management of burns, ulcers, and fistulas. It is also used in facial reconstruction, sinonasal repair, and various types of hernia repairs.

Conclusion
Biodesign represents a versatile and well-researched technology for advanced tissue repair, offering a natural scaffold for effective tissue regeneration across a wide range of medical applications.
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Catalog excerpts

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Illustration by Lisa Clark.

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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 structural molecules that helps guide the growth of cells.1 Cook’s proprietary processing methodology decellularizes the SIS material while preserving natural matrix molecules such as collagen, proteoglycans, and glycosaminoglycans.2 The result is a scaffold that, when implanted, provides a location for host cells...

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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.3 Porcine small intestine, submucosa in blue. The body's signaling mechanisms help patient cells infiltrate the scaffold and completely remodel into natural host tissue. SIGNALS Extracellular matrix structure of lyophilized porcine small intestinal submucosa

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Microscopic view of the remodeling process2 Biodesign graft prior to implantation 8 months after implantation The Biodesign graft (left) allows for the substantial growth of organized tissue, as seen in this biopsy sample, taken eight months after implantation (right). The above images are of the Biodesign Plastic Surgery Matrix implanted in breast tissue.4

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What is the result? The result is a durable repair consisting of vascularized tissue. Placement of a Biodesign graft

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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.

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A proven technology. With more than 1,400 total published articles, Biodesign is one of the most well-studied graft technologies on the market.* Published OHNS studies* Randomized, controlled trials* *As of 1 May 2018.

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• 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. Porcine small intestinal submucosa (SIS) myringoplasty in children: a randomized controlled study. Int J Pediatr Otorhinolaryngol. 2015;79(7):1085-1089. • James AL. Endoscope or microscope-guided pediatric tympanoplasty? Comparison of grafting technique and outcome. Laryngoscope. 2017;127(11):2659-2664. • De Zinis LO, Berlucchi M, Nassif N. Double-handed endoscopic myringoplasty with a holding system...

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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

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OTOLOGI C REPAI R GRAFT

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1. Hubbell JA. Materials as morphogenetic guides in tissue engineering. Curr Opin Biotechnol. 2003;14:551-558. 2. Hodde J, Janis A, Ernst D, Zopf D, Sherman D, Johnson C. Effects of sterilization on an extracellular matrix scaffold: Part I. Composition and matrix architecture. J Mater Sci Mater Med. 2007;18(4):537-543. 3. Data on file. Cook Biotech Internal Report #D00199545. 4. Data on file. Cook Biotech Internal Report #D00199430. To learn more, visit cookmedical.com/otolaryngology. To contact us, visit cookmedical.com/connect.

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.