Intragastric balloons for obesity: critical review of device design, efficacy, tolerability, and unmet clinical needs.

Expert review of medical devices Pub Date : 2024-01-01 Epub Date: 2024-02-04 DOI:10.1080/17434440.2023.2289691
Sara Ameen, Hamid A Merchant
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Abstract

Introduction: Sustaining a healthy weight is a challenge and obesity, with associated risk of co-morbidities, is a major public health concern. Bariatric surgery has shown a great promise for many where pharmacological and lifestyle interventions failed to work. However, challenges and limitations associated with bariatric surgery has pushed the demand for less invasive, reversible (anatomically) interventions, such as intragastric balloons (IGBs).

Areas covered: This review critically appraises IGBs used in the past, present, and those in clinical trials, discussing the device designs, limitations, placement and removal techniques, patient eligibility, efficacy, and safety issues.

Expert opinion: Several intragastric balloons were developed over the years that brought excitement to patients and healthcare professionals alike. Albeit good efficacy, there had been several safety issues reported with IGBs such as spontaneous deflation, intestinal occlusion, gut perforation, and mucosal ulcerations. This led to evolution of IGBs design; device material, filling mechanism, fluid type, inflation volume, and further innovations to ease ingestion and removal of device. There are some IGB devices under development aimed to swallow like a conventional pill and excrete naturally through defecation, however, how successful they will be in clinical practice in terms of their efficacy and tolerability remains to be seen in the future.

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胃内气球治疗肥胖:设备设计、疗效、耐受性和未满足的临床需求的关键回顾。
导论:保持健康的体重是一项巨大的挑战,肥胖已成为一种具有相关合并症风险的流行病,因此是全世界公共卫生机构关注的主要问题。手术干预,如减肥手术,在许多药物和生活方式干预无效的地方显示出巨大的希望。然而,与减肥手术相关的挑战和局限性推动了对微创、可逆(解剖)干预的需求,例如胃内气球(igb)。涵盖领域:本综述批判性地评价了过去、现在和临床试验中使用的igb,讨论了设备设计、局限性、放置和移除技术、患者资格、有效性和安全性问题。专家意见:多年来,一些胃内气球被开发出来,给病人和医疗保健专业人员带来了兴奋。尽管igb疗效良好,但也存在一些安全性问题,如自发充气(球囊过早破裂)、肠道闭塞、肠道穿孔和粘膜溃疡。这导致了igb设计的演变;设备材料,填充机制和流体类型,充气体积,以及进一步的创新,以减轻设备的摄入和移除。有一些IGB装置正在开发中,旨在像传统药丸一样吞咽,并在肠道内生物降解后通过排便自然排出,然而,它们在临床实践中的有效性和耐受性如何成功仍有待于未来的观察。
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