THE EVOLUTION OF EVH AND CONDUIT QUALITY MCV

THE EVOLUTION OF EVH AND CONDUIT QUALITY MCV 00002512

EVH: THE STANDARD OF CARE § Highly evolved systems, developed over the past 15 years § Eight generations of devices, along with accessory line, have been introduced § Product features, harvester training and understanding of physiological mechanisms affecting graft patency has significantly improved § Emphasis on conduit quality and patient outcomes © MAQUET 29 -Oct-20 MCV 00002512 2

EVH: THEN & NOW § 1995: EVH was an innovative alternative to invasive open surgery § Today, 95% of U. S. hospitals use EVH § Successes supported by 15 years of peer-reviewed, randomized studies § Over 1 million EVH procedures performed worldwide 2008 STS Floor Survey and market research data on file. MAQUET Cardiovascular. 2008 © MAQUET 29 -Oct-20 MCV 00002512 3

EVH: THE EARLY YEARS § Tenfold increase in procedures 1997 -2000 § Clear patient benefits 2008 STS Floor Survey and market research data on file. MAQUET Cardiovascular. 2008 © MAQUET 29 -Oct-20 MCV 00002512 4

EVH: 1999– 2000 § Reduced patient complications § No histological difference between EVH and open vessel harvesting Yun KL, et al. Randomized trial of endoscopic versus open vein harvest for coronary artery bypass grafting: six-month patency rates. J Thorac Cardiov Surg. 2005; 129: 496 -503. Davis Z, et al. Endoscopic vein harvest for coronary artery bypass grafting: technique and outcomes. J Thorac Cardiov Surg. 1998; 116: 228 -235. Allen KB, et al. Endoscopic versus traditional saphenous vein harvesting: a prospective, randomized trial. Ann Thorac Surg. 1998; 66: 26 -32. Kan CD, et al. Endoscopic saphenous vein harvest decreases leg wound complications in coronary artery bypass grafting patients. J Cardiac Surg. 1999; 1: 157 -162. Crouch JD, et al. Open versus endoscopic saphenous vein harvesting: wound complications and vein quality. Ann Thorac Surg. 1999; 68: 1513 -1516. Carpino PA, et al. Clinical benefits of endoscopic vein harvesting in patients with risk factors for saphenectomy wound infections undergoing coronary artery bypass grafting. J Thorac Cardiov Surg. 2000; 119: 69 -76. Patel AN, et al. Prospective analysis of endoscopic vein harvesting. Am J Surg. 2002; 73: 523 -528. Bitondo JM, et al. Endoscopic versus open saphenous vein harvest: a comparison of postoperative wound complications. Ann Thorac Surg. 2002; 73: 523 -528. © MAQUET 29 -Oct-20 MCV 00002512 5

EVH: 2003– 2005 § No significant difference in event-free survival over a 5 -year follow-up period 1 § Largest prospective randomized angiographic study of EVH versus open vessel harvesting: no compromoise in 6 month patency rate 2 § 2005: ISMICS recognizes EVH as The Standard of Care for vessel harvesting for patients undergoing CABG surgery 3 1. Allen KB, et al. Influence of endoscopic versus traditional saphenectomy on event-free survival: five-year follow-up of a prospective randomized trial. Heart Surg Forum. 2003; 6: E 143 -145. 2. Yun KL, et al. Randomized trial of endoscopic versus open vein harvest for coronary artery bypass grafting: six-month patency rates. J Thorac Cardiov Surg. 2005; 129: 496 -503. 3. Allen KB, et al. Endoscopic Vascular Harvest in Coronary Artery Bypass Grafting Surgery: A Consensus Statement of the International Society of Minimally Invasive Cardiothoracic Surgery (ISIMICS) 2005. Innovations: Technology & Techniques in Cardiothoracic & Vascular Surgery. Winter 2005; 1: 51 -60. © MAQUET 29 -Oct-20 MCV 00002512 6

EVH: 2006– 2009 Pre-heparinization gains adoption as “EVH best practice” § Low-dose heparin bolus associated with: – Four-fold reduction in graft failure – Reduction in incidence and volume of residual clot strands § Use of heparin is associated with improved patency in saphenous vein grafts Poston RS, et al. Heparin Administration Prior to Endoscopic Vein Harvest Limits Clot Retention and Improves Graft Patency. Abstract. ISMICS. June 8, 2009. © MAQUET 29 -Oct-20 MCV 00002512 7

EVH: 2009– 2010 Increased focus on need to optimize conduit quality § Endothelial injury found to decrease long-term graft patency 1, 2 – Preventing overdistension with pressure control – Limiting thermal spread to <1 mm § VASOSHIELD Pressure Controlling Syringe controls vessel distension § VASOVIEW HEMOPRO pre-clinical study demonstrates mean thermal spread of 0. 19 mm 3 § VASOVISION Endoscopic Visualization System 1. Thatte HS, et al. The coronary bypass conduit: I. Intraoperative endothelial injury and its implication on graft patency. Ann Thorac Surg. 2001; 72: S 2245 -52 2. Angelini GD, et al. Metabolic damage to human saphenous vein graft during preparation for coronary artery bypass grafting. Cardiovasc Res. 1985; 19: 326 -34. 3. Lombardi P. Measurement of thermal spread from use of VASOVIEW® HEMOPRO: study demonstrates minimal thermal injury to endothelium. San Jose, CA MAQUET Cardiovascular; 2008. © MAQUET 29 -Oct-20 MCV 00002512 8

EVH – KEY LEARNINGS FROM EXPERIENCE § Meticulous vein handling protects endothelial integrity § Pre-heparinization has significant clinical benefits § Product ergonomics, control and precision matter § On-going harvester training and support is an important factor for success © MAQUET 29 -Oct-20 MCV 00002512 9

TRAINING BUILDS EVH STRENGTH § Optimizing techniques helps improve harvester success § MAQUET Program Resources: § Clinical Expertise Available § Global Sites for Hands-on Opportunities § Visiting Clinical “Ambassadors” from U. S. § Classroom/Workshop events § Leg model practice © MAQUET 29 -Oct-20 MCV 00002512 10

A PROMISING FUTURE MAQUET Cardiovascular is committed to EVH technology § Continue to refine the market leading VASOVIEW platform § Focus and investment in the field of cardiac surgery § Focused on improving patient outcomes § Close collaboration and partnership with practicing clinicians in the development of next generation products and innovations © MAQUET 29 -Oct-20 MCV 00002512 11