Carpentier-Edwards. ThermaFix Advanced Tissue Process. The only tissue process to remove both major calcium binding sites 5

Transcription

1 Carpentier-Edwards ThermaFix Advanced Tissue Process The only tissue process to remove both major calcium binding sites 5

2 Prepare to change the way you think about tissue treatments The ThermaFix process advantage An effective tissue treatment targets calcification Glutaraldehyde fixation is only the first step in the tissue treatment process 7 Glutaraldehyde fixation helps in tissue preservation, sterility, improved biocompatibility and structural stability 7 Extraction is better than coating The ThermaFix advanced tissue process extracts phospholipids and unstable or residual glutaraldehyde molecules 5 Other tissue treatments may only coat these calcium binding sites. As a result, their anticalcification effect may be reversible 9 MECHANISM OF ACTION Untreated leaflet tissue in the body Tissue phospholipids and unstable glutaraldehyde molecules are major calcium binding sites, which lead to tissue calcification. 5 ThermaFix process Step 1: Unstable glutaraldehyde molecule removal in the lab Proprietary thermal treatment removes unstable glutaraldehyde molecules, a major calcium binding site. 1-6 ThermaFix process Step 2: Phospholipid removal in the lab Patented chemical treatment removes 98% of tissue phospholipids, a major calcium binding site. 5,6 Treated leaflet tissue in the body As the only tissue treatment to remove both major calcium binding sites, the ThermaFix advanced tissue process reduced calcium uptake by up to 81% over glutaraldehyde controls in small animal studies. 5 See our mechanism of action at

3 Not a reversible binding like other tissue treatments 9 Durability and tissue treatment The ThermaFix advanced tissue process is available on the Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis, which is designed with 20-year unparalleled durability data. 8 ThermaFix advanced tissue process results As the only tissue treatment to extract both major calcium binding sites, the proprietary ThermaFix advanced tissue process reduced calcium uptake by up to 81% over glutaraldehyde controls in small animal studies. 1,2,5,6

4 Animal test results calcium uptake reduction Up to 81% reduction in calcium uptake over glutaraldehyde controls 5 RAT SUBCUTANEOUS IMPLANT STUDY, days RABBIT INTRAMUSCULAR IMPLANT STUDY, 5 28 days 75% reduction in calcium uptake over controls in juvenile sheep study SHEEP HEART VALVE IMPLANT STUDY (n=6) 5

5 ThermaFix advanced tissue process. The only tissue process to extract both major calcium binding sites 5 Removing unstable glutaraldehyde molecules with proprietary thermal heat treatment reduces calcium binding 1-6 Removes 98% of phospholipids with patented chemical treatment 5,6 Not a reversible binding like other tissue treatments 9 The ThermaFix process difference According to available literature, there are two major binding sites for calcium which lead to tissue calcification. 5 Tissue phospholipids Residual or unstable glutaraldehyde molecules While other tissue treatments may extract or coat one of these two calcium binding sites, only the ThermaFix advanced tissue process extracts both sites. 1-6

6 The only tissue process to remove both major calcium binding sites 5 Removing unstable glutaraldehyde molecules with proprietary thermal heat treatment reduces calcium binding 1-6 Removes 98% of phospholipids with patented chemical treatment 5,6 Not a reversible binding like other tissue treatments 9 Up to 81% reduction in calcium uptake over glutaraldehyde controls in small animal studies 5 References: 1. McIntosh DB. Glutaraldehyde Cross-links Lys-492 and Arg-678 at the Active Site of Sarcoplasmic Reticulum Ca(2+)-ATPase. J Biol Chem 1992;267(31): Bruylants A, et al. Cleavage of the carbon-nitrogen double bond. In Satai P (ed): Chemistry of the Carbon-Nitrogen Double Bond, John Wiley and Sons: Process Development 1970: Carpentier SM, et al. Biomechanical Properties of Heat-treated Valvular Bioprostheses. Ann Thorac Surg 2001;71(5 Suppl):S Carpentier SM, et al. Heat Treatment Mitigates Calcification of Valvular Bioprostheses. Ann Thorac Surg 1998;66(6 Suppl):S Data on file at Edwards Lifesciences RD784, RD 795, RD 597, RD 127 and RD Cunanan CM, et al. Tissue Characterization and Calcification Potential of Commercial Bioprosthetic Heart Valves. Ann Thorac Surg 2001;71(5 Suppl):S Southern LJ, et al. Glutaraldehyde indeed cross-links: a study of model compounds and commercial bioprosthetic valves. J Heart Valve Dis 2000;9(2): Carpentier-Edwards PERIMOUNT Aortic Pericardial Bioprosthesis 20-year Results. Data on file at Edwards Lifesciences Chen W, et al. Mechanism of efficacy of 2-amino oleic acid for inhibition of calcification of glutaraldehyde-pretreated porcine bioprosthetic heart valves. Circulation 1994;90(1): No clinical data are available which evaluate the long-term impact of the Edwards Lifesciences tissue treatment in patients. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information. Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity. Edwards Lifesciences, Edwards, the stylized E Logo, ThermaFix, and XenoLogiX are trademarks of Edwards Lifesciences Corporation. Carpentier-Edwards and PERI- MOUNT are trademarks of Edwards Lifesciences Corporation and are registered in the U.S. Patent and Trademark office Edwards Lifesciences LLC All rights reserved. AR00726 Edwards Lifesciences LLC One Edwards Way Irvine, CA USA Edwards Lifesciences (Canada) Inc Central Pkwy West, Suite 300 Mississauga, Ontario Canada L5C 4R3 Phone Edwards Lifesciences S.A. Ch. du Glapin Saint-Prex Switzerland Phone Edwards Lifesciences Japan 2-8 Rokubancho Chiyoda-ku, Tokyo Japan Phone