Medical devices for the treatment of obesity

Abstract

Obesity is a major public health concern that leads to numerous metabolic, mechanical and psychological complications. Although lifestyle interventions are the cornerstone of obesity management, subsequent physiological neurohormonal adaptations limit weight loss, strongly favour weight regain and counteract sustained weight loss. A range of effective therapies are therefore needed to manage this chronic relapsing disease. Bariatric surgery delivers substantial, durable weight loss but limited access to care, perceived high risks and costs restrict uptake. Medical devices are uniquely positioned to bridge the gap between more conservative lifestyle intervention and weight-loss pharmacotherapy and more disruptive bariatric surgery. In this Review, we examine the range of gastrointestinal medical devices that are available in clinical practice to treat obesity, as well as those that are in advanced stages of development. We focus on the mechanisms of action as well as the efficacy and safety profiles of these devices. Many of these devices are placed endoscopically, which provides gastroenterologists with exciting opportunities for treatment.

Endoscopic bariatric and metabolic therapies: Another tool for the management of diabetes and obesity

“…Although similar in design to the IGB, the system instead functions to cause intermittent gastric outlet obstruction due to occlusion of the pylorus to induce satiety as opposed to a space‐occupying mechanism. The larger bulb also prevents migration of the system into the small intestine . According to a small feasibility study of 20 patients (ENDObesity I), the TBWL at 6 months with the TPS was 14.5% .…”

“…Endobarrier (GI Dynamics, Boston, Massachusetts) is a 65‐cm liner that can be endoscopically deployed into the duodenum to prevent access of food to the duodenal mucosa, effectively acting as a temporary bypass mechanism delivering nutrients via a sleeve straight to the jejunum prior to absorption. The Endobarrier has been studied in patients for use for up to 12 months, although it is not yet FDA approved …”

“…The FDA pivotal trial (ENDO) was terminated early due to high rates of hepatic abscess formation after the procedure . Preliminary data did show an increase in TBWL by 5.6% and a reduction in HbA1c by an average of 0.8% compared with the sham procedure control …”

“…The larger bulb also prevents migration of the system into the small intestine. 4,31,32 According to a small feasibility study of 20 patients (ENDObesity I), the TBWL at 6 months with the TPS was 14.5%. 31,32 Because many of the patients in that small-scale study developed gastric ulceration with this system, a newer generation of the TPS is currently being studied in a multicenter randomized controlled trial.…”

“…4,31,32 According to a small feasibility study of 20 patients (ENDObesity I), the TBWL at 6 months with the TPS was 14.5%. 31,32 Because many of the patients in that small-scale study developed gastric ulceration with this system, a newer generation of the TPS is currently being studied in a multicenter randomized controlled trial. 4 The Full Sense Bariatric Device (Baker, Michigan) is an endoscopically placed stent that traverses the gastroesophageal junction (GEJ) and places pressure on the distal esophagus and gastric cardia to induce satiety.…”