Emerging LVAD Technology for the Use - Washington Hospital Center

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HeartWare MVAD Trans-Apical “MVAD”: Left Thoracotomy • Device in LV with inflow pointing toward apex • Outflow in ascending aorta • Benefits: very quick implantation, no outflow graft, no bypass • Questions: device in LV, aortic valve integrity
• Intraventricular axial flow pump • CE Mark 5/05 • US BTT IDE Pivotal Study Jarvik 2000 ® VAS • 150 patient enrollment completed in 2011 – Study enrollment will continue up to maximum of 160 subjects – Pilot and Pivotal cohorts total 213 subjects – Continuing Access Protocol (CAP) application in Q1 2012 – PMA application to be submitted in 2012
Page 1 and 2: Emerging LVAD Technologies for the
Page 3 and 4: Continuous Flow LVADs • Thoratec
Page 5 and 6: • Electrically powered • Percut
Page 7 and 8: • FDA approved Thoratec HeartMate
Page 9 and 10: Thoratec HeartMate III • Full-mag
Page 11 and 12: *In development and not available f
Page 13 and 14: HeartWare Ventricular Assist System
Page 17 and 18: Sintered HVAD Inlet
Page 19 and 20: HeartWare MVAD • Wide blade impel
Page 21: HeartWare MVAD Trans-Mitral “MVAD
Page 25 and 26: Future applications • Total Ventr
Page 27 and 28: MicroMed HeartAssist 5 ® VAD Heart
Page 29: CircuLite ® Synergy ® Micro-Pump
Page 33 and 34: Potential VAD Patient Opportunity U
Page 35: Are We Ready?
Page 41 and 42: Fully-Implantable System: Energy Tr
Page 43: • GLP animal studies completed He

Emerging LVAD Technology for the Use - Washington Hospital Center

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