MOVE BEYOND. to new hope for enterocutaneous fistulas. Enterocutaneous Fistula Repair

Transcription

1 MOVE BEYOND to new hope for enterocutaneous fistulas. Enterocutaneous Fistula Repair

2 to an alternative treatment option Enterocutaneous fistulas can significantly affect patient health and quality of life. Cook Medical s Biodesign enterocutaneous fistula plug is specifically designed to correct this notoriously difficult and often debilitating condition. Constructed from Biodesign a non dermis-based and non cross-linked biologic graft and engineered for easy placement, the enterocutaneous fistula plug is designed to assist the patient s body in closing the tract on its own. Molnar disk ensures Biodesign material remains positioned throughout the tract. Biodesign is designed to be remodeled by the body when suitable conditions are established.* 4 or 7 mm diameter and 18 cm length fit most fistula tracts. Radiopaque flange creates a seal to restrict fluids from entering the tract while also providing a method *When device is placed appropriately and seal is established to keep bowel contents out of fistula tract, Biodesign can be remodeled by the patient s of visualization during placement. 2 body to assist in closing the fistula tract. Proper placement technique can 3 be achieved only after completing a certified clinical training program.

3 to remodel patient tissue Biodesign is a non-dermis, non-cross-linked biologic graft technology that is remodeled into strong, well-vascularized tissue. DERMIS BASED Dermis-based grafts contain high amounts of elastin. This elastin remains in the patient s body and can stretch, possibly leading to an ineffective repair. NON-DERMIS BASED Biodesign is non-dermis based, so it does not contain meaningful amounts of elastin. With proper placement, the body remodels Biodesign into patient tissue that maintains long-term strength. SYNTHETIC/ BIOABSORBABLE MESH BIOLOGIC GRAFT NON-CROSS LINKED Biodesign has been designed to maintain strength throughout the remodeling process, so there is no need for cross-linking. And because Biodesign is remodeled completely into strong, vascularized tissue, it can provide a strong repair without a permanent material. BIODESIGN A D VA N C E D T I S S U E R E PA I R CROSS-LINKED Cross-linked biologic grafts inhibit remodeling and vascular ingrowth, and have been associated with chronic inflammation and encapsulation. 4 5

4 to converging technologies The Biodesign enterocutaneous fistula plug combines Cook Medical s proven percutaneous access technology with an advanced biologic graft technology, Biodesign. These technologies work together to provide an unprecedented treatment option for enterocutaneous fistula. Documented Efficacy Initial evaluation has shown that 42% of patients received clinical benefit from placement of the Biodesign enterocutaneous fistula plug. Initial Product Evaluation Results 1 Complete Fistula Closure/Patients 4/19 21% Reduced Drainage Reported/Patients 4/19 21% Fistula Tracts Closed/Number of Fistulas 7/26 27% A Comprehensive Set The enterocutaneous fistula plug set includes the components necessary for successful percutaneous placement: Biodesign enterocutaneous fistula plug Transfer tube Flexor delivery sheath (16 or 22 Fr) Dilator Pusher Molnar disk Procedures/Plugs Deployed Correctly 2 22/22 100% Physician Evaluators 10 Complete fistula closure + reduced drainage reported = 42% of patients received clinical benefit from using the Biodesign enterocutaneous fistula plug. 1 Study conducted 2009-Feb Data on file All procedures were performed following a certified clinical training program.

5 Move beyond to continual improvement Biodesign is the evolution of a technology that started the biologic graft soft-tissue repair revolution. BIODESIGN Discovery of SIS Small intestinal submucosa (SIS) is used as an aortic replacement in a canine model. Remarkably, the SIS is fully remodeled into vascular tissue. Surgisis is released After rigorous research and development, Cook receives FDA clearance for release of Surgisis, the first medical-grade hernia device made from SIS-based technology. Processing improvements In response to surgeon feedback, substantial improvements in the processing are made, opening the structure to allow the body to more easily infiltrate and remodel the graft. Biodesign released Additional improvements are made to the base technology, speeding rehydration and mitigating perioperative issues. The new generation of grafts is renamed Biodesign. 8 A D V A N C E D T I S S U E R E PA I R 9

6 to Biodesign Reasons to choose Biodesign for enterocutaneous fistula repair. An intact extracellular matrix, Biodesign is processed in a way that preserves its natural structure, supporting tissue remodeling. Derived from proven technology demonstrated effective in more than 1,000,000 patient treatments across a range of conditions. With proper placement, Biodesign is remodeled into strong, vascularized patient tissue, providing long-term strength without a permanent material. Non cross-linked, so no residual cross-linked material is left behind to encapsulate, erode or become infected. Has specific data showing efficacy across a wide variety of procedures including ventral hernia repair, fistula repair, wound treatment and pelvic floor restoration. Has undergone more than 12 years of evolution based on surgeon feedback and scientific research. Based on a technology that has been the subject of more than 861 peer-reviewed journal articles, including 9 randomized controlled trials. Randomized Controlled Trials Ansaloni L, Catena F, D Alessandro L. Prospective randomized, double-blind, controlled trial comparing Lichtenstein s repair of inguinal hernia with polypropylene mesh versus Surgisis gold soft tissue graft: preliminary results. Acta Biomed. 2003; 74(suppl 2): Mostow EN, Haraway GD, Dalsing M, et al. Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial. J Vasc Surg. 2005;41(5): Niezgoda JA, Van Gils CC, Frykberg RC, et al. Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers. Adv Skin Wound Care. 2005;18(5, pt 1): Oelschlager BK, Pellegrini CA, Hunter J, et al. Biologic prosthesis reduces recurrence after laparoscopic paraesophageal hernia repair: a multicenter, prospective, randomized trial. Ann Surgery. 2006;244(4): Romanelli M, Dini V, Bertone M, et al. OASIS wound matrix versus Hyaloskin in the treatment of difficult-to-heal wounds of mixed arterial/venous aetiology. Int Wound J. 2007:4(1):3-7. Landsman A, Roukis TS, DeFronzo DJ, et al. Living cells or collagen matrix: which is more beneficial in the treatment of diabetic foot ulcers? Wounds. 2008;20(5): Ansaloni L, Catena F, Coccolini F, et al. Inguinal hernia repair with porcine small intestine submucosa: 3-year follow-up results of a randomized controlled trial of Lichtenstein s repair with polypropylene mesh versus Surgisis Inguinal Hernia Matrix. Am J Surg. 2009;198(3): Romanelli M, Dini V, Bertone MS. Randomized comparison of OASIS wound matrix versus moist wound dressing in the treatment of difficult-to-heal wounds of mixed arterial/venous etiology. Adv Skin Wound Care. 2010;23(1): Feldner PC Jr, Castro RA, Cipolotti LA, et al. Anterior vaginal wall prolapse: a randomized controlled trial of SIS graft versus traditional colporrhaphy. Int Urogynecol J. 2010;21(9):

7 If you are interested in bringing a new procedure to your practice and learning an innovative treatment option for enterocutaneous fistula repair, please contact your local Cook Medical district manager. To learn more about Biodesign, visit COOK 2011 SUR-BM-EFPMP-EN