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• W2804486075 abstract "Cardiac pacemakers, implantable cardioverter-defibrillators, and electrode catheter systems are essential for the treatment of patients with cardiac arrhythmias. The widespread and rapidly expanding use of these antiarrhythmic devices has focused attention on the need for thorough, efficient, and practical assessment of their safety, efficacy, and clinical usefulness. In general, the effectiveness of these devices is well documented. Their capabilities may be enhanced through incorporation of existing technology and future innovations, and it is anticipated that the range of clinical indications requiring intervention and the demand for use of antiarrhythmic devices will continue to grow. A multidisciplinary policy conference was held November 15 and 16, 1993, in Washington, DC, to facilitate formal communication among interested parties involved in the development and use of antiarrhythmic devices. Participants included representatives of divisions of the Food and Drug Administration (FDA) responsible for overseeing the pre–market release evaluation and post–market release surveillance of antiarrhythmic devices and the Health Industry Manufacturers Association, representing the device manufacturing industry. This statement focuses on the types of clinical evaluation necessary for commercial release and subsequent assessment of antiarrhythmic devices. Generally the term clinical investigation describes the broad area of scientific studies pertaining to human pathophysiology and therapeutics. In this report, the term clinical evaluation refers to a specific class of clinical investigations performed as part of a government-mandated biomedical regulatory mission (Fig 1⇓). Figure 1. Schematic diagram showing the relation between different types of clinical investigation undertaken in development of an antiarrhythmic device, its clinical application, and its commercial release. The phases of clinical evaluation and subsequent process are detailed at left. Other clinical investigations performed for scientific inquiry are delineated at right. Interrelations between the two processes and their relations to practice guidelines, outcomes research, clinical usefulness, and postmarketing studies are broadly presented.This statement is based on a …" @default.
• W2804486075 created "2018-06-01" @default.
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• W2804486075 date "1995-04-01" @default.
• W2804486075 modified "2023-09-25" @default.
• W2804486075 title "Clinical Investigation of Antiarrhythmic Devices" @default.
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