Cardiac resynchronization devices: the Food and Drug Administration's regulatory considerations |
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Authors: | Moynahan Megan Faris Owen P Lewis Brian M |
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Affiliation: | aCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, Maryland |
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Abstract: | Cardiac resynchronization therapy (CRT) devices have been studied clinically since 1998, and have been on the U.S. market since the Food and Drug Administration (FDA) approval of the first product in 2001. Since that time, the FDA has approved many different models from three different manufacturers, representing the first and second generations of these products. All of these products have undergone the FDA pre-market approval process, which examines the safety and effectiveness of the devices for their intended use. Over the last several years, the FDA has adapted recommendations for CRT clinical trials based on an evolving understanding of what these devices can achieve. This paper will outline the dynamic nature of the FDA's approval process for CRT devices and briefly review the clinical trial designs for the first generation devices. |
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Keywords: | Abbreviations: CRT, cardiac resynchronization therapy EF, ejection fraction FDA, Food and Drug Administration ICD, implantable cardioverter-defibrillator LV, left ventricular NYHA, New York Heart Association |
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