1. “ Development of an Axial Flow Left Ventricular Assist Device (LVAD) from Inception to Clinical Application” George P. Noon, MD Professor of Surgery Chief, Division of Transplant & Assist Devices Meyer-DeBakey Chair of Investigative Surgery Pumps & Pipes

2. Heart Failure Hospitalizations The number of heart failure hospitalizations is increasing in both men and women CDC/NCHS: Hospital discharges include patients both living and dead. AHA Heart and Stroke Statistical Update 2001

3. CIRCULATORY ASSIST DEVICES The Methodist Hospital/Baylor College of Medicine IABP (1971-2001) 2880 Roller Pump (1971-1988) 94 DeBakey VAD (1963-1966) 6 Liotta, Hall, Crawford (1963) 1 Symbion/Jarvik (1987-1989) 4 Novacor ® LVAS (1987-2005) 53 BioMedicus ® (1986-2005) 274 MicroMed DeBakey-Noon VAD ® (2000-2005) 36 Thoratec ® LVAD (1998-2005) 31 HeartMate ® VAD (2001-2005) 17 Abiomed ® BVS 5000 (2002-2004) 7 Abiomed ® AB 5000 (2003-2004) 1

5. Biomedical Engineering Role in Development of Total Artificial Heart and Assist Pumps

9. First NASA Axial Flow Prototype Two rotating components

11. Licensed NASA Blood Pump (1996)

12. Hemolysis Test Setup

13. Red Cells

14. Hemolyzed Red Cells

17. Schematic Illustration of the DeBakey VAD

18. Bovine tests at Baylor College of Medicine, Texas A&M Ex-Vivo In-Vivo

19. Novacor  HeartMate  DeBakey-Noon VAD  Device Comparison

20. DeBakey VAD ® and DeBakey VAD Child

21. Controller Pump Patient Home Support System Data Acquisition System Result: MicroMed DeBakey VAD ® System

22. DeBakey-Noon VAD ® Patient Ergonomics

23. Comparative VAD Space Requirements HeartMate ® XVE LVAD Adult Male DeBakey VAD ® 6 year old girl

25. Physiologic Blood Flow Systemic Pulmonary Textbook of Medical Physiology, Arthur C. Guyton

26. Speed, Flow and Delta Pressure

27. Hypoperfusion Operating Range Potential for Suction Flow Characteristics

28. Arterial Pressure - Green VAD Flow - Yellow Pump speed VAD flow (kRPM) (L/min) OFF -2.0 7600 2.3 8900 4.5 10,800 5.6 10 0 -4 0 140 10 0 -4 0 140 10 0 -4 0 140 10 0 -4 0 140

30. Milan Smaller Patients Possible Miniaturization benefits large and small patients. Milan Zurich Muenster

32. Results - CFD Baseline Rear Hub Washout Final Rear Hub Washout Increase gap shows an improved circulation pattern in the rear hub

33. Results - CFD Baseline Diffuser Inlet Angle Final Diffuser Inlet Angle Flow is entering the diffuser correctly on the pressure side of the blade indicating a small “angle of attack.”

35. Results – Flow Visualization Results from increased gap: Less turbulence in the diffuser Baseline Design 2.0x Gap

36. Results – Hemolysis at 4 L/min INCREASING THE GAP WITHOUT MODIFYING THE DIFFUSER INLET ANGLE DEMONSTRATES A TREND TO SLIGHLY HIGHER HEMOLYSIS 2.0X gap Baseline Baseline 2.0X gap, 32 ° TUNING THE DIFFUSER INLET ANGLE WITH THE LARGER GAP DEMONSTRATES A TREND OF HEMOLYSIS LOWER THAN THE BASELINE VALUE; HOWEVER, THERE IS NO STATISTICAL DIFFERENCE IN HEMOLYSIS BETWEEN THE BASELINE AND FINAL DESIGN N.I.H. = 0.006 N.I.H. = 0.014 N.I.H. = 0.009 N.I.H. = 0.006

37. X2 Pump Design ½ cm shorter intra-ventricular and 1cm shorter extra-ventricular length for improved anatomical fitting Smoother inlet flare for improved blood flow into the pump Seamless connection to pump housing for improved blood flow Smaller flow probe cover Titanium ring integral to gelatin sealed graft for easy, leak-free assembly

38. On the horizon…

39. Clinical Benefits of the MicroMed DeBakey-Noon VAD Size Surgeon Patient Implant Less Awareness Explant Drive Line Smaller Patients Noiseless Device Infection  5% Adequate Circulatory Support Less Expensive