DermaMatrix Acellular Dermis. Comparative testing.

Transcription

1 DermaMatrix Acellular Dermis. Comparative testing. Natural, like native tissue Minimally processed Strong and flexible

2 DermaMatrix Acellular Dermis. Human dermal collagen matrix. Unique process DermaMatrix has unique processing that does not impact human skin properties. DermaMatrix High concentration sodium chloride Non-ionic detergent Peracetic acid Other matrices Acetone Gamma irradiation E-beam sterilization Peptide released per unit mass (mg/ml/g) Enzyme degradation and crosslinking: DermaMatrix is most similar to unprocessed human tissue. 1 Degradation Crosslinking Unprocessed DermaMatrix AlloDerm Strattice firm Strattice pliable AlloMax Synthes DermaMatrix Acellular Dermis

3 Matrix that is closest to natural human tissue DermaMatrix retains the architectural elements of human unprocessed skin, allowing natural healing. 2,3 Unprocessed human natural skin DermaMatrix AlloDerm AlloMax Strattice Minimal processing of DermaMatrix maintains the natural characteristics of collagen. 4 Collagen proteins separated by molecular weight through sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE). Smaller, degraded proteins migrate lower in the gel, whereas larger, crosslinked proteins remain higher in the gel. Collagen in DermaMatrix is similar to unprocessed human skin. Unprocessed human natural skin Purified collagen 1 DermaMatrix AlloDerm AlloMax Permacol Strattice DermaMatrix Acellular Dermis Synthes 1

4 DermaMatrix Acellular Dermis. Human dermal collagen matrix. Innovative: Strong and Flexible DermaMatrix has the greatest tensile strength of all leading matrices. 5 2 Tensile strength * *P <.5 15 MPa 1 5 DermaMatrix AlloDerm Strattice Strattice firm pliable AlloMax DermaMatrix stands out with natural memory to resist excessive stretching. 5 Modulus of elasticity 15 1 MPa 5 DermaMatrix AlloDerm Strattice Strattice firm pliable AlloMax Images and charts based on preclinical data, unless otherwise stated. 2 Synthes DermaMatrix Acellular Dermis

5 Integration with native tissue DermaMatrix has natural components and architecture that support cellular infiltration and revascularization. Hyaluronan is present in all living organisms and provides matrix structure, osmotic balance and assists with cell migration and differentiation. Vitronectin, an adhesive glycoprotein, binds to collagen and promotes cell attachment, proliferation and differentiation. Both hyaluronan and vitronectin are found in DermaMatrix. 2 Immunohistochemical staining using Alcian Blue/PAS shows the presence of hyaluronan in DermaMatrix as indicated by indigo staining Immunohistochemical staining shows vitronectin in DermaMatrix as indicated by brown staining. Histology courtesy of Premier Laboratory, LLC. DermaMatrix shows healthy revascularization after 8 weeks, without adhesions to internal organs. 6 Rabbit abdominal wall Clinical evidence of DermaMatrix integration. DermaMatrix is visibly (4X magnification) populated with fibroblasts, indicating integration of the dermal matrix into soft tissues. Numerous red blood cells are also apparent in blood vessels within DermaMatrix, demonstrating neovascularization. Image courtesy of Dr. John Y.S. Kim. Three months after placement in patient. DermaMatrix Acellular Dermis Synthes 3

6 DermaMatrix Acellular Dermis. Human dermal collagen matrix. DermaMatrix outperforms Strattice in preclinical study. 6 Hernia tissue graft success 1 1% Postimplantation tensile strength Success 6 5 5% 3 25 (n=8) 4 2 MPa 3 15 (n=8) (n=4) (n=4) DermaMatrix 2 weeks Strattice DermaMatrix Strattice DermaMatrix Strattice 1 2 Weeks postimplantation Preclinical studies indicate a 1% hernia graft success rate for DermaMatrix. However, 5% of Strattice grafts resorbed or thinned, resulting in hernia defect or recurrence. 6 Proven performance DermaMatrix shows 3X greater tissue ingrowth than Strattice in preclinical study. 6 Tissue ingrowth % Tissue Ingrowth (%) % * Preclinical studies performed in a rabbit model and not necessarily indicative of clinical results. DermaMatrix 4 weeks Strattice 4 Synthes DermaMatrix Acellular Dermis

7 Quality and Safety Standards DermaMatrix is available through the Musculoskeletal Transplant Foundation (MTF). MTF adheres to quality and safety standards developed by leading physicians, transplant surgeons, and specialists in the fields of science and medicine Donor screening criteria are among the most stringent of any tissue bank MTF meets and exceeds the standards and regulations of the American Association of Tissue Banks (AATB) and the Food and Drug Administration (FDA) References 1. Choi B. (Report) LE-282: Analysis of Extracellular Matrix (ECM) Characteristics via Enzyme Degradation Assay. February 2, Ngo, MD. (Report) LE-268: Extracellular Matrix Components in Acellular Dermis. December 22, Data on file. 4. Choi B. (Report) LE-284: Characterization of Acellular Dermis via SDS-PAGE. August 27, Choi B. (Report) LE-271: Analysis of Tensile Testing Data of Acellular Dermis. February 6, Ngo MD, Aberman HM, Fanfan D. Comparative effectiveness of human and porcine acellular dermal matrices for incisional hernia repair in the rabbit. Data on file. Other Clinical and Preclinical References Bachman S, Ramshaw B. Prosthetic material in ventral hernia repair: how do I choose? Surg Clin North Am. 28;88(1): Buck DW 2nd, Heyer K, Dibardino D, Bethke K, Kim JY. Acellular dermis-assisted breast reconstruction with the use of crescentric tissue expansion: a functional cosmetic analysis of 4 consecutive patients. Aesthet Surg J. 21;3(2): Gocke DJ. Tissue donor selection and safety. Clin Orthop Relat Res. 25;(435):17-21 Louie L. The use of ALLODERM versus DermaMatrix in implant based breast reconstruction. Plast and Reconstr Surg. June 21 Supplement. Maxwell GP, Gabriel A. Use of the acellular dermal matrix in revisionary aesthetic breast surgery. Aesthet Surg J. 29;29(6): Ngo M, Gertzman A. Acellular dermis for use in reconstructive surgery. Presented at: Biologic Scaffolds for Regenerative Medicine 5th Symposium, Phoenix, Arizona, February 15-16, 28. Roth JS, Dexter DD, Lumpkins K, Bochicchio GV. Hydrated vs. freeze-dried human acellular dermal matrix for hernia repair: a comparison in a rabbit model. Hernia. 29;13(2): Topol BM, Dalton EF, Ponn T, Campbell CJ. Immediate single-stage breast reconstruction using implants and human acellular dermal tissue matrix with adjustment of the lower pole of the breast to reduce unwanted lift. Ann Plast Surg. 28;61(5): Eberli D, Rodriguez S, Atala A, Yoo JJ. In vivo evaluation of acellular human dermis for abdominal wall repair. J Biomed Mater Res A. 21;93(4): DermaMatrix Acellular Dermis Synthes 5

8 Musculoskeletal Transplant Foundation (MTF) Synthes has partnered exclusively with the Musculoskeletal Transplant Foundation (MTF) for over 1 years to provide high quality tissue for patients. Although there are national standards for tissue banks, they only set a baseline for the industry. Beyond that, regulations leave a lot to interpretation, so standards vary significantly from tissue bank to tissue bank. MTF offers safe allografts processed from among the most carefully selected donors. MTF s standards are set by their Medical Board of Trustees more than 4 surgeons from world-renowned academic institutions. Directed by Surgeons MTF utilizes a Medical Board of Trustees comprised of more than forty surgeons from world-renowned academic institutions. MTF s board sets standards, which are among some of the most stringent in the industry. Selecting the Ideal Donor MTF s extensive network of participating organ procurement organizations ensures that MTF has access to a broad selection of qualified donors. MTF holds itself to stringent standards for donor selection and processing criteria. MTF defers more donors than they accept. MTF Donor Deferral Rate > 97% deferred < 3% accepted Preserving and Protecting Tissue Integrity MTF s approach ensures a high level of safety, without compromising biological and mechanical integrity. MTF has developed and validated several tissue cleaning technologies to provide safe and high quality allograft. Since MTF s inception, MTF has maintained an exemplary safety record distributing almost 5.1 million allografts from over 91, donors. 6 Synthes DermaMatrix Acellular Dermis

9 Product Information DermaMatrix Tissue Code Description Thickness Ultra Thin cm x 2 cm.2 mm.4 mm cm x 4 cm.2 mm.4 mm cm x 7 cm.2 mm.4 mm Thin cm x 1 cm.4 mm.8 mm cm x 2 cm.4 mm.8 mm cm x 2 cm.4 mm.8 mm cm x 4 cm.4 mm.8 mm cm x 4 cm.4 mm.8 mm cm x 7 cm.4 mm.8 mm cm x 7 cm.4 mm.8 mm cm x 12 cm.4 mm.8 mm cm x 12 cm.4 mm.8 mm Thick cm x 1 cm.8 mm 1.7 mm cm x 2 cm.8 mm 1.7 mm cm x 4 cm.8 mm 1.7 mm cm x 4 cm.8 mm 1.7 mm cm x 7 cm.8 mm 1.7 mm cm x 7 cm.8 mm 1.7 mm cm x 1 cm.8 mm 1.7 mm cm x 12 cm.8 mm 1.7 mm cm x 12 cm.8 mm 1.7 mm cm x 12 cm.8 mm 1.7 mm cm x 16 cm.8 mm 1.7 mm cm x 16 cm.8 mm 1.7 mm cm x 16 cm.8 mm 1.7 mm cm x 12 cm.8 mm 1.7 mm cm x 16 cm.8 mm 1.7 mm cm x 16 cm.8 mm 1.7 mm cm x 2 cm.8 mm 1.7 mm cm x 2 cm.8 mm 1.7 mm cm x 2 cm.8 mm 1.7 mm cm x 2 cm.8 mm 1.7 mm cm x 2 cm.8 mm 1.7 mm cm x 24 cm.8 mm 1.7 mm cm x 25 cm.8 mm 1.7 mm Tissue Code Description Thickness Ultra Thick cm x 1 cm 1.8 mm cm x 12 cm 1.8 mm cm x 12 cm 1.8 mm cm x 16 cm 1.8 mm cm x 16 cm 1.8 mm cm x 16 cm 1.8 mm cm x 12 cm 1.8 mm cm x 16 cm 1.8 mm cm x 16 cm 1.8 mm cm x 2 cm 1.8 mm cm x 2 cm 1.8 mm cm x 2 cm 1.8 mm cm x 2 cm 1.8 mm cm x 2 cm 1.8 mm cm x 24 cm 1.8 mm cm x 25 cm 1.8 mm Breast Kits 2 units from same donor, Thick B cm x 12 cm.8 mm 1.7 mm B cm x 16 cm.8 mm 1.7 mm B cm x 16 cm.8 mm 1.7 mm B cm x 16 cm.8 mm 1.7 mm Breast Kits 2 units from same donor, Ultra Thick B cm x 12 cm 1.8 mm B cm x 16 cm 1.8 mm B cm x 16 cm 1.8 mm B cm x 16 cm 1.8 mm DermaMatrix Acellular Dermis Synthes 7

10 Available through Synthes CMF 132 Wrights Lane East West Chester, PA 1938 Telephone: (61) To order call: (8) Fax: (877) Processed by Musculoskeletal Transplant Foundation 125 May Street Edison, NJ 8837 Telephone: (732) Fax: (732) Synthes and DermaMatrix are trademarks of Synthes, Inc. or its affiliates. MTF is a registered trademark of the Musculoskeletal Transplant Foundation. AlloDerm is a registered trademark and Strattice is a trademark of LifeCell 212 Synthes, Inc. or its affiliates. All rights reserved. Corporation. AlloMax is a trademark of C.R. Bard, Inc. Permacol is a trademark of Covidien AG or its affiliate. Printed in U.S.A. 3/12 J11255-A