EVERYTHING ABOUT MECHANICAL VALVES HAS CHANGED

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1 EVERYTHING ABOUT MECHANICAL VALVES HAS CHANGED CryoLife - New Brochure FIN.indd 1 06/10/ :08

2 Why use another mechanical valve when No other mechanical valve has: 1 90 leaflets: 1 promotes laminar flow 2 Pure pyrolytic carbon: reduces thrombogenicity 2 3 Flared inlet: prevents pannus; organises flow Step Ahead with Aortic Valve: INR * 50% closer to a normal INR 3 >60% reduction in bleeding 1 No increase in thromboembolism (TE) 1 *Reduce INR after 3 months standard therapy CryoLife - New Brochure FIN.indd 2 06/10/ :08

3 Aortic Valve: 50% Closer to a Normal INR 3 Aortic Heart Valve patients with an INR of had a >60% reduction in bleeding events and no increase in TE compared to patients with an INR of * All other bileaflet aortic valve anticoagulation should be managed at an INR of INR vs. Event Rate 5 Event Rate (%/pt-yr) Normal INR Range ( ) 6 Aortic Valve INR Range All Other Bileaflet Aortic Valves INR Range (AHA/ACC) Bleeding TE < INR *Reduce INR after 3 months standard therapy 1 Optimal Haemodynamics The Aortic Heart Valve provides optimal mean gradients compared with other bileaflet and bioprosthetic aortic heart valves at 1 year. 1,7-11, Mean Gradients at 1 Year Mean Gradient (mmhg) From FDA Reviewed Data Mean Gradients at 1Yr Aortic Valve 1 St. Jude Medical Regent 7 CarboMedics Prosthetic Heart Valves 8, Medtronic Open Pivot Standard, AP **, & AP360 **9 Carpentier-Edwards Perimount Magna and Magna Ease 10 Medtronic Mosaic Porcine Bioprosthesis Valve Size (mm) **Medtronic Open Pivot AP and AP360 (formerly ATS): 16 = 19, 18 = 21, 20 = 23, 22 = 25, 24 = 27, 26 = 29 Postoperative data. Note: Mean gradients for Aortic Valve 27 and 29 were combined CryoLife - New Brochure FIN.indd 3 06/10/ :08

4 Aortic Heart Valve All Other Bileaflet Aortic Heart Valves 90º Opening <90º Opening Aortic Heart Valves have leaflets that can open 90º to promote better laminar flow. All other bileaflet aortic heart valves have leaflets that can only open 78º to 85º.9,12 Smoother Surface Rougher Surface Aortic Heart Valves have a smoother surface13 on the entire body and leaflets to reduce thrombogenicity.2 All other bileaflet aortic heart valves have rougher surfaces13 that are more thrombogenic.2 Smooth Pivot2 Pure Pyrolytic Carbon2 Rough Machined Pivot2 Silicon Alloyed: Pyrolytic Carbon2 Complete Annulus Support Incomplete Annulus Support Aortic Heart Valves have a flared inlet designed to prevent pannus and conceal pledgets. All other bileaflet aortic heart valves have unprotected inlets, allow pannus, and exposes pledgets CryoLife - New Brochure FIN.indd 4 06/10/ :09

5 INTRODUCING The only aortic mechanical valve FDA and CE approved and clinically proven to be safer with less anticoagulation. * 50% closer to a normal INR. 3 *Reduce INR after 3 months standard therapy CryoLife - New Brochure FIN.indd 5 06/10/ :08

6 Aortic Valve Patients Patients who desire: An active lifestyle The lowest warfarin therapy of all mechanical aortic valves * [ ] The balance between valve durability versus risk of bleeding and thromboembolic events favors the choice of a mechanical valve in patients <60 years of age. (2014 AHA/ACC Guidelines) 4 Patients who are: 70 years (2014 AHA/ACC Guidelines) 4 Anticipated to be on long-term warfarin therapy (e.g. chronic Afib or DVT) 4,15,16 Durability: not being afraid of having a future aortic valve reoperation 4,13 *Reduce INR after 3 months standard therapy 1 Fred Hoiberg, Age 43 Head Coach: Chicago Bulls Aortic Valve Recipient I couldn t be happier with everything involved. First of all, getting the mechanical valve and second getting the valve. The way I feel now, after the valve replacement, I feel like I did when I was playing. I feel great, and I m thankful I got the valve that I did. Mike, Age 54 Competitive Cyclist Aortic Valve Recipient The aortic valve would allow me to take lower blood thinner levels [ and] continuing my cycling activities for many years to come. Note: Outcomes may vary per patient. Aortic Heart Valve Configurations Anatomic Conform-X Standard Sizes (mm) 19, 21, 23, 25, 27/29 1. Prosthetic Heart Valve Instructions for Use. 2. LaGrange L et al., Compatibility of carbon and blood. Hegyeli RJ, Editor, Proceedings, Artificial Heart Program Conference, Washington, DC, June 9-13, 1969, Normal INR is considered 1. WHO Expert Committee on Biological Standardization, 33rd Report, World Health Organization, downloaded on 06/29/ Nishimura R et al., 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014;63: e Data on file. 6. Levine M et al., Monitoring of international normalized ratios: comparison of community nurses with family physicians. Can Fam Physician 2012;58:e St. Jude Medical Physician s Manual Mechanical Heart Valve. 8. CarboMedics Prosthetic Heart Valve Instructions for Use. 9. Medtronic Open Pivot Heart Valve Instructions for Use. 10. Edwards Life Sciences Carpentier- Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX Instructions for Use. 11. Medtronic Mosaic Porcine Bioprosthesis with Cinch Advanced Implant System Instructions for Use. 12. Kandemir O et al., St. Jude Medical and Carbomedics mechanical heart valves in the aortic position comparison of long term results. Tex Heart Inst J. 2006; 33: More R and Haubold A. Surface chemistry and surface roughness of clinical pyrocarbons. Cell Mater. 1996;6: Korteland N et al., Quality of life and prosthetic aortic valve selection in non-elderly adult patients. Interact Cardiovasc Thorac Surg. 2016; 22: Yanagawa B et al., Anticoagulation for prosthetic heart valves: unresolved questions requiring answers. Curr Opin Cardiol. 2016; 31: Coumadin Labeling on FDA website. label/2010/009218s108lbl.pdf, downloaded on 05/24/2016. Learn more at: ML (06/2016) Life Technologies, Inc East Anderson Lane Bldg. B Austin, Texas USA Tel: (512) Fax: (512) onx@onxlti.com CryoLife, Inc Roberts Boulevard NW, Kennesaw, Georgia, USA Tel: Fax: CUSTSVC@cryolife.com Bramley House The Guildway Old Portsmouth Road Guildford, Surrey GU3 1LR United Kingdom Tel: +44 (0) Fax: +44 (0) europaorders@cryolife.com Emergo Europe Molenstraat 15, 2513 BH The Hague, The Netherlands Life Technologies, Inc. is a wholly owned subsidiary of CryoLife, Inc. The prosthetic heart valves are manufactured by Life Technologies, Inc. CryoLife, the snowflake design, Life Restoring Technologies, and are registered trademarks owned by CryoLife, Inc. or its subsidiaries. All other registered trademarks are owned by their respective owners CryoLife, Inc. All rights reserved CryoLife - New Brochure FIN.indd 6 06/10/ :08