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SynCardia Systems, Inc.

Right Ventricular Dysfunction or Failure after Left Ventricular Assist Device Implantation

Most mechanical circulatory support (MCS) systems augment blood flow through the failing ventricle(s). While these devices may reduce the patient's symptoms and slow the progression of heart failure, they do not stop it. Many professional papers have documented the incidence of right ventricular dysfunction or failure after implantation of a left ventricular assist device (LVAD). Definitions of right ventricular dysfunction and failure vary by paper. Similar to a heart transplant, the SynCardia temporary Total Artificial Heart replaces both failing heart ventricles and the four native heart valves. It is the only approved device in use that eliminates the source of end-stage biventricular failure.

Selected Reports and Professional Papers

Pre-Market Approval Results for the HeartMate II


  of patients developed right heart failure during the pre-market approval of the HeartMate II. Source: HeartMate II FDA Summary of Safety and Effectiveness

ADVANCE Clinical Study Results for the HeartWare HVAD


  of patients developed right heart failure requiring either a right ventricular assist device (RVAD) or inotropic support. Source: Evaluation of the HeartWare HVAD Left Ventricular Assist System for the Treatment of Advanced Heart Failure: Results of the ADVANCE Bridge to Transplant Trial; Keith Aaronson, Mark Slaughter, Edwin McGee, et al. for the HeartWare ADVANCE Investigators; American Heart Association Scientific Sessions November 2010

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