Tutopatch and Tutomesh

Transcription

1 Tutopatch and Tutomesh Bovine Pericardium Implant Overview

2 About RTI Surgical Strong commitment to advancing science, safety and innovation. Leading global surgical implant company providing safe biologic, metal and synthetic implants. Innovator in proprietary, validated tissue sterilization processes that include viral inactivation steps. More than five million implants sterilized with zero incidence of implant-associated infection. Accredited in the U.S. by the American Association of Tissue Banks, ISO Certified and an AdvaMed Member. Table of Contents Introduction....1 Overall Implant Features....1 Safety....2 Tutoplast Tissue Sterilization Process....2 Strength....3 Revascularization and Remodeling....4 Histological Scores for Fibroblast Repopulation and Revascularization...4 Tutopatch and Tutomesh Implant Histology....4 Clinical Evidence....5 Ordering Guide...6

3 Tutopatch Bovine Pericardium and Tutomesh Fenestrated Bovine Pericardium Natural Collagen Matrix Tutopatch bovine pericardium and Tutomesh fenestrated bovine pericardium are natural collagenous matrices. Processed through the Tutoplast Tissue Sterilization Process, both implants offer a safe and natural biologic option for soft tissue repair. The Tutopatch and Tutomesh implants offer three important components of a biologic implant: safety, strength and support for revascularization and remodeling. Additionally, the material properties of bovine pericardium allow the implants to conform to anatomic structures, making it suited for surgical applications such as parastomal and hiatal hernia repair. OVERALL IMPLANT FEATURES Available in: Fenestrated and non-fenestrated Rectangular and oval shapes Conforms to anatomical structures 1

4 SAFETY SAFETY Tutopatch bovine pericardium and Tutomesh fenestrated bovine pericardium are processed through the Tutoplast Tissue Sterilization Process. Validated multi-step chemical preservation and sterilization process that removes antigenicity and inactivates pathogens Validated low dose gamma irradiation achieves terminal sterility of SAL 10-6 Tutoplast processed bovine pericardium has been utilized safely in applications including dura repair, dental, hernia, plastic and reconstructive surgery and women s health. TUTOPLAST TISSUE STERILIZATION PROCESS (Tutopatch bovine pericardium and Tutomesh fenestrated bovine pericardium) The Tutoplast process was originally developed more than 40 years ago by Tutogen Medical. During the Tutoplast process, osmotic, oxidative and alkaline treatments break down cell walls, inactivate pathogens and remove bacteria. Solvent dehydration results in room temperature storage without damaging the native tissue structure. Overall the structure, biomechanics and remodeling characteristics of the implant are maintained. Low dose gamma irradiation ensures sterility of the final packaged graft. VETERINARY INSPECTION 2 TISSUE BEFORE PROCESSING TUTOPLAST TISSUE STERILIZATION PROCESS TISSUE SHAPED INTO FINAL FORM AND PACKAGED LOW-DOSE TERMINAL IRRADIATION STERILE FINISHED GRAFT TO SAL 10-6

5 STRENGTH STRENGTH Despite the naturally thin nature of bovine pericardium, it is inherently strong. The material s strength comes from the composition of the tissue s structure. Native bovine pericardium is comprised of multi-directional collagen fibers that are approximately 90% Type I collagen. Many three-stranded Type I collagen molecules pack together side-by-side forming fibrils, which results in high tensile strength. In fibrils, adjacent collagen molecules are displaced from one another thus creating a staggered, striated effect that can be seen in scanning electron micrographs (SEM). If the network of collagen fibers is altered during processing, mechanical strength could be compromised. Tutopatch bovine pericardium has been shown to preserve this network of collagen fibers after processing as shown in the SEM image below.1 It is important to preserve the material characteristics that are well suited to resist the tensile forces placed on it during soft tissue repair. In a head-to-head comparison against Veritas Collagen Matrix, Tutopatch bovine pericardium was shown to have a defined collagen structure similar to non-processed bovine pericardium, whereas Veritas exhibited dramatically altered collagen structure. Further, pre-implant, out of the package testing revealed Tutopatch bovine pericardium demonstrated significantly greater uniaxial max load, UTS and modulus than Veritas.1 Tutopatch bovine pericardium has been shown to preserve the native multi-directional network of collagen fibers.1 35 Tutopatch Veritas (Average ± Standard Deviation) Bovine pericardium after the Tutoplast Tissue Sterilization Process, Smooth surface, 5000x magnification. Thickness All Tests (mm) Uniaxial UTS Modulus Max (MPa) (MPa) Load (N) Suture Pull-out Load (N) Mechanical testing data from Tutopatch bovine pericardium and Veritas pre-implant. Indicates statistical significance (p < 0.05). 3

6 REVASCULARIZATION & REMODELING REVASCULARIZATION AND REMODELING (ANIMAL MODEL) Tutopatch bovine pericardium and Tutomesh fenestrated bovine pericardium have demonstrated rapid revascularization, repopulation and remodeling.3 Explant gross evaluation revealed that Tutopatch bovine pericardium integrated well with surrounding host tissue at four, eight and 12 weeks. Histologic analysis revealed that Tutopatch bovine pericardium had more favorable remodeling characteristics when compared to Veritas. In an animal model, the Tutopatch and Tutomesh implants have demonstrated fast tissue integration via cell repopulation and rapid revascularization in addition to remodeling over time. HISTOLOGICAL SCORES FOR FIBROBLAST REPOPULATION AND REVASCULARIZATION (ANIMAL MODEL) Tutopatch Veritas Tutopatch Veritas 2.5 Neovascularization Score Fibroblast Repopulation weeks 8 weeks 12 weeks Histological scores for fibroblast repopulation of Tutopatch bovine pericardium and Veritas at four, eight and 12 weeks post implantation. 4 weeks 8 weeks 12 weeks Histological scores for revascularization of Tutopatch bovine pericardium and Veritas at four, eight and 12 weeks post implantation. TUTOPATCH AND TUTOMESH IMPLANT HISTOLOGY3 (CLINICAL BIOPSY) PRE-IMPLANTATION NINE MONTHS AFTER IMPLANTATION 36 MONTHS AFTER IMPLANTATION Collagen is stained in yellow, elastin fibers appear in red Collagenous tissue with blood vessels proves revascularization Tissue shows revascularization with blood vessels and cells, completely remodeled 4 Performance data from animal studies may not be representative of performance in humans.

7 CLINICAL EVIDENCE CLINICAL EVIDENCE Demonstrated low recurrence rate and minimal complications clinically, 3 resulting in a proven technology for hernia repair. 43 Implant Recipients Post-Surgery Follow Up, Complicated Incisional Hernia Repair Diameter > 4cm 0% implant infections, 0% implant migration, 0% implant shrinkage No implant was explanted in five-year follow up 5.3% wound infection rate 7.9% rate of seroma 9.3% recurrence rate at five years 1 Qiu Qing-Qing, Zhukauskas Rasa, Wachs Rebecca A., Ely Amanda In Vitro and In Vivo Comparison of Tutopatch Bovine Pericardium and Veritas Collagen Matrix for Hernia Repair. 2 Van Tuil C., Saxena A.K., Willital G.H., Experience with management of anterior abdomen wall defects using bovine pericard. Hernia : Urbach V., Linderman M., Shaheen I., Paolucci V. Data on file. Department of General Surgery and Visceral Surgery, Kettler Hospital, Offenbach, Germany. 5

8 ORDERING GUIDE TUTOPATCH BOVINE PERICARDIUM AND TUTOMESH FENESTRATED BOVINE PERICARDIUM IMPLANTS Part Number BP0608 BP0618 BP0811 BP0814 BP0816 BP0818 BP1013 BP1016 BP1212 BP1216 BP1420 BP3016 BP3322 Description Tutopatch bovine pericardium 6 x 8cm Tutopatch bovine pericardium 6 x 18cm Tutopatch bovine pericardium 8 x 11cm Tutopatch bovine pericardium 8 x 14cm Tutopatch bovine pericardium 8 x 16cm Tutopatch bovine pericardium 8 x 18cm Tutopatch bovine pericardium 10 x 12.5cm Tutopatch bovine pericardium 10 x 16cm Tutopatch bovine pericardium 12 x 12cm Tutopatch bovine pericardium 12 x 16cm Tutopatch bovine pericardium 14 x 20cm Tutomesh fenestrated bovine pericardium 10 x 16cm Oval Tutomesh fenestrated bovine pericardium 13 x 22cm Oval Call or rticustomerservice@rtix.com to coordinate product availability with your local representative. When Biologics are the Answer, Trust RTI Surgical. Optimized for Safety and Designed for Results. indicates U.S. registration. All trademarks and/or images are the property of their respective owners or holders. Distributed by RTI Surgical, Inc Research Circle Alachua, FL USA t: rticustomerservice@rtix.com 2014 RTI Surgical, Inc. All rights reserved R1 12/23/24