1. Positive Clinical Outcomes including low thrombosis, low hemolysis, and low infection.^1,2,4,5,7
2. Reliability⁸ made possible by precision engineering such as advanced, patented bearing design, a single-moving part, and back-up controller electronics.
3. Ease of Implantation facilitates treatment of a broad patient population, and a small (400 gm) device allows small pocket and shorter surgical times.⁹
4. Improved Patient Qualify of Life and functional class allows patients to return to daily life at home.^6,7,9 Patients typically do not feel or perceive the VAD's presence due to its small size and light weight.⁶
5. Ease of Patient Management facilitated by a thin, flexible driveline designed to reduce infections, simple user interface on peripherals, and standardized equipment shared with the HeartMate XVE LVAS.
6. Thoratec Support offers unrivaled education and training with exceptional clinical, technical, and reimbursement assistance.

The HeartMate II LVAS is designed to provide Hemodynamic Restoration Therapy (HdRT) for a broad range of heart failure (HF) patients. NYHA Class III or IV HF patients treated with HdRT by means of a ventricular assist device (VAD) improve to a less severe classification, typically Class I or II.^10,11,12

HdRT with a VAD supports the function of the natural heart, restoring flow and hemodynamics.

VAD support can trigger a series of physiological responses that significantly improve patient quality of life.^6,7,10,11,12

• Hemodynamic function is restored, enabling patients to return home and resume an active life
• HF symptoms are alleviated
• Liver and kidney function are improved
• Quality of life is improved
• Survival is improved

There have even been patients for whom VAD therapy has been a bridge to full recovery, leading to eventual removal of the mechanical circulatory support device.^13,14

The HeartMate II LVAS incorporates many features specifically intended to minimize the risk of complications and improve device durability while enhancing patient outcomes. The simple design-with one moving part-contributes substantially to reliable operation. The unique hydrodynamic bearings are designed for low wear.⁸ The blood flow path has been optimized to ensure thorough washing of surfaces and eliminate stagnation. And blood contacting surfaces are designed to avoid blood damage. As a result, the HeartMate II LVAS is exceptionally durable and thromboresistant.

1. Single moving part enhances durability and reliability
2. Hydrodynamic bearings are designed to provide smooth, trouble-free operation and to minimize thrombosis
3. Blood path is biocompatible and designed to avoid hemolysis
4. Textured surfaces are clinically proven in the HeartMate XVE LVAS to be thromboresistant
5. Small, 9 mm diameter percutaneous driveline is designed to minimize infection and improve patient comfort
6. Flexible inflow and outflow conduits accommodate anatomical changes and patient movement

1. Frazier OH, Delgado RM, Kar B, Patel V, Gregoric ID, Myers TJ: First clinical use of the redesigned HeartMateŽ II Left Ventricular Assist System in the United States: a case report, Tex Heart Inst J 2004;31:157-9, Erratum in: Tex Heart Inst J. 2004;31(3):333.
2. Pagani FD, Strueber M, Naka Y, Kormos RL, Long JW, Dowling RD, Massey HT, Farrar DJ, Frazier OH. Initial multicenter clinical results with the HeartMate II axial flow left ventricular assist device. J Heart and Lung Transplant 2005;24(suppl I):S74.
3. Tsukui H, Winowich S, Stanford E, Teuteberg JL, Kormos RL: Does a rotary pump provide full cardiac decompression and circulatory support? From clinical experiences of HeartMate II with severe congestive heart failure patients. ASAIO J 2005: 51(2): 28A.
4. Strueber M, Pagani FD, Naka Y, Kormos RL, Long JW, Dowling RD, Massey HT, Frazier OH: Clinical multicenter experience with a novel axial LVAD (HeartMate II) in over 60 and under 60 age groups. European Association for Cardiothoracic Surgery, Barcelona, Sept 24-28, 2005.
5. Chen L, Delgado RM, Maybaum S, Kormos RL, Massey HT, Farrar DJ: A new therapeutic option for women in advanced heart failure: Results of the HeartMate II continuous flow left ventricular assist device clinical pilot study. Heart Failure Society of America, Boca Raton, Sep 18-21, 2005.
6. Delgado RM III, Smart F, Gregoric I, Radovancevic B, Bergheim M, Shah N, Carranza S, Myers T, Frazier OH: Quality of life in patients implanted with the HeartMate II left ventricular assist device for severe heart failure. Heart Failure Society of America, Boca Raton, Sep 18-21, 2005.
7. Kormos RL, Strueber M, Frazier OH, Naka Y, Massey T, Pagani FD, Dowling R, Smedira N, Conte J, Long J: HeartMate II axial flow left ventricular assist device: suitability for advanced congestive heart failure. American Heart Association, Dallas, TX, Nov 15, 2005.
8. Butler KC, Farrar DJ: Long-term reliability testing of the HeartMate II LVAD. ASAIO J 2005: 51(2): 32A.
9. Data on file, Thoratec Corporation.
10. Frazier OH, Rose EA, Oz MC, Dembitsky W, McCarthy P, Radovancevic B, Poirier VL, Dasse KA. Multicenter clinical evaluation of the HeartMate vented electric left ventricular assist system in patients awaiting heart transplantation. J Thorac Cardiovasc Surg. Dec 2001;122(6):1186-1195.
11. Rose EA, Gelijns AC, Moskowitz AJ, Heitjan DF, Stevenson LW, Dembitsky W, Long JW, Ascheim DD, Tierney AR, Levitan RG, Watson JT, Meier P. Long-term mechanical left ventricular assistance for end-stage heart failure. N Engl J Med. Nov 15, 2001;345(20):1435-1443.
12. REMATCH Update (as of April 2004). Source: Thoratec Registry.
13. Korfer R, el-Banayosy A, Posival H, Minami K, Kizner L, Arusoglu L, Korner MM. Mechanical circulatory support with the Thoratec assist device in patients with post-cardiotomy cardiogenic shock. Ann Thorac Surg. Jan 1996;61(1):314-316.
14. Simon MA, Kormos RL, Murali S, Nair P, Heffernan M, Gorcsan J, Winowich S, McNamara DM: Myocardial recovery using ventricular assist devices: Prevalence, clinical characteristics, and outcomes. Circulation. 2005; 112[suppl I]:I 32-36.
15. Morgan JA, Weinberg AD, Hollingsworth KW, Flannery MR, Oz MC, Naka Y. Effect of gender on bridging to transplantation and post-transplantation survival in patients with left ventricular assist devices. J Thorac Cardiovasc Surg. Apr 2004; 127(4):1193-1195.