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  1. 423 Posts.
    Clinical Trial - Thoratec


    United States

    REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive HeartFailure)
    The REMATCH clinical trial was designed to evaluate the effect of heart pumps in heart failure patients who are not eligible for a heart transplant. The trial compared the outcomes of patients who received a heart pump with the outcomes of patients whose heart failure was treated using conventional medical treatment (such as medications, diet, and exercise). Patients were selected at random to be included in either the heart pump group or the medically-managed group. The trial was collaboration among the National Institutes of Health (NIH), Columbia University, and Thoratec Corporation (the heart pump manufacturer). The trial was coordinated by Columbia's International Center for Health Outcomes and Innovation Research (InCHOIR).

    The results of the trial showed that heart failure patients who received a heart pump had better outcomes than patients whose heart failure was managed by conventional treatments alone. Based on the results of the REMATCH trial, the FDA has approved the HeartMate SNAP-VE Left Ventricular Assist System (LVAS) as a treatment option for patients who have end-stage heart failure, but who are not eligible for heart transplantation.

    Europe

    HeartMate II
    The HeartMate II Left Ventricular Assist System (LVAS) is Thoratec's next generation rotary blood pump in our family of implantable pumps treating end-stage heart disease. The HeartMate II is designed to address the need for smaller, long lasting devices that will address Destination Therapy for patients requiring long-term cardiac support.

    A multi-center European clinical trial will allow Thoratec to evaluate the performance of the HeartMate II as a therapy for end-stage heart failure. Once the trial has been completed, application will be made for the CE Mark in order for commercialization in the European Union
 
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