Anti-Obesity Medical Devices

H. Heshmati
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引用次数: 2

Abstract

Obesity is a major health problem worldwide responsible for increased mor-bidity/mortality and high cost for the society. Management of obesity requires multidisciplinary approaches including diet, food supplement, exercise, behavior change, drug, medical device, gut microbiome manipulation, and surgery. Antiobesity medical devices are an option for subjects who have not responded to more conservative medical treatments but want an alternative to surgery. Compared to bariatric surgery, they have the advantage of being less invasive, easier to perform, and reversible. In the United States of America (USA), based on the expected weight loss, the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) categorizes anti-obesity medical devices as weight-loss devices or weight-management devices. The weight-loss devices include gastric band devices, gastric space-occupying devices, and gastric emptying devices. The weight-management devices include oral removable palatal space-occupying devices and ingested transient gastric space-occupying devices. The effectiveness, safety, and cost of anti-obesity medical devices vary considerably by the type of medical device. Their use should always be combined with lifestyle changes. Considering the large market size of obesity treatment, anti-obesity medical devices can play a major role in the management of obesity.
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抗肥胖医疗设备
肥胖是世界范围内的一个主要健康问题,造成了发病率/死亡率的增加和社会成本的高昂。肥胖的管理需要多学科的方法,包括饮食、食物补充、运动、行为改变、药物、医疗设备、肠道微生物组操作和手术。对于那些对更保守的药物治疗没有反应但想要替代手术的受试者来说,抗肥胖医疗设备是一个选择。与减肥手术相比,它们的优点是侵入性较小,更容易实施,并且可逆。在美利坚合众国(USA),根据预期的体重减轻,食品和药物管理局(FDA)的器械和放射健康中心(CDRH)将抗肥胖医疗器械分类为减肥器械或体重管理器械。所述减肥装置包括胃带装置、胃占位装置和胃排空装置。体重管理装置包括口腔可移动腭占位装置和摄入的瞬时胃占位装置。抗肥胖医疗设备的有效性、安全性和成本因医疗设备的类型而有很大差异。它们的使用应该与生活方式的改变相结合。考虑到肥胖治疗的巨大市场规模,抗肥胖医疗设备可以在肥胖的管理中发挥重要作用。
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