Performance/Sizing

Mechanical Aortic Heart Valves

Top Hat Aortic Options Tabulated to Patient's Annulus Diameter Patient's Annulus Diameter(mm) 17 19 21 23 Applicable Top Hat Heart Valve Sizes(mm) 19 21 21 23 23 25 25 27 Mean Pressure Gradients (mmHg) 19.4 12.3 12.3 9.8 9.8 8.3 8.3 8.8 Mean Velocity (m/s) 2.01 1.60 1.60 1.44 1.44 1.33 1.33 1.35 Peak Pressure Gradient (mmHg) 40.1 28.2 28.2 20.0 20.0 16.0 16.0 17.7 Peak Velocity (m/s) 3.12 2.48 2.48 2.15 2.15 2.02 2.02 2.01 Effective Orifice Areas (cm2) 1.0 1.5 1.5 1.6 1.6 2.0 2.0 2.4

R-Series and Standard Intra-Annular Aortic Performance Valve Size(mm) 19 21 23 25 27 29 31 Mean Pressure Gradient(mmHg) 19.4 12.3 9.8 8.3 8.8 5.8 5.8 Mean Velocity (m/s) 2.01 1.60 1.44 1.33 1.35 1.10 1.10 Peak Pressure Gradient (mmHg) 40.1 28.2 20.0 16.0 17.7 10.8 10.8 Peak Velocity (m/s) 3.12 2.48 2.15 2.02 2.01 1.90 1.90 Effective Orifice Areas (cm2) 1.0 1.5 1.6 2.0 2.4 2.6 2.6

Mechanical Mitral Heart Valves

Standard Mitral, Optiform Mitral, and Orbis Mitral Performance Valve Size (mm) 23 25 27 29 31 33 Mean Pressure Gradient (mmHg) 7.0 4.1 3.9 3.3 3.3 3.4 Peak Pressure Gradient (mmHg) 18.0 9.4 10.5 10.1 8.6 7.6 Peak Velocity (m/s) 2.10 1.48 1.55 1.55 1.41 1.35 Pressure Half-time (ms) 104 81 78 67 83 79 Effective Orifice Area (cm2) 1.3 2.2 2.1 2.1 1.9 2.3