*7.1.2.1 Orbera™ Intragastric balloon system*

Orbera™ Intragastric Balloon System (Apollo Endosurgery, Inc.) is a balloon made of silicone placed endoscopically in the stomach (**Figure 2**). The balloon is filled with saline mixed with methylene blue (450–700 mL). The methylene blue is a marker for balloon dysfunction. In case of balloon rupture, the methylene blue will be systematically absorbed and change the color of urine to blue. The procedure is minimally invasive and can be performed in an outpatient setting. The balloon is removed endoscopically after 6 months. By occupying gastric volume, Orbera™ Intragastric Balloon System causes early satiety and a decrease in food intake with subsequent weight loss [8, 11, 13, 14].

In the pivotal study, 255 subjects (229 females, 26 males, mean BMI = 35.3 kg/m<sup>2</sup> ) were randomized into Orbera™ Intragastric Balloon System (n = 125) or control (no intragastric intervention, n = 130) arms for 6 months and 6 months follow-up after Orbera™ Intragastric Balloon System removal. Safety analysis also included an additional 35 run-in, non-randomized subjects who received Orbera™ Intragastric Balloon System. All subjects were given lifestyle recommendations. The co-primary effectiveness endpoints, assessed in the modified intentionto-treat (mITT) population at Month 9, were the excess weight loss in Orbera™ Intragastric Balloon System arm and a significantly greater weight loss in Orbera™ Intragastric Balloon System arm compared to control arm. At Month 9, the excess weight loss was 26.5% in Orbera™ Intragastric Balloon System arm, and the weight losses were 9.1 and 3.4% in Orbera™ Intragastric Balloon System and control arms, respectively. The study did not meet the first co-primary effectiveness endpoint but met the second co-primary effectiveness endpoint. At Month 6, the weight losses were 10.2 and 3.3% in Orbera™ Intragastric Balloon System and control arms, respectively. A total of 810 device-related AEs was observed (mainly nausea/vomiting, gastroesophageal reflux, and abdominal pain, mild or moderate in the majority of cases). Fourteen device- or procedure-related SAEs were observed, mainly device intolerance but no death.

**Figure 2.** *Orbera™ Intragastric Balloon System (Apollo Endosurgery, Inc.—Picture downloaded from the internet).*

**245**

**Figure 3.**

*Anti-Obesity Medical Devices*

*7.1.2.2 Obalon Balloon System*

weight loss [8, 13, 14].

*DOI: http://dx.doi.org/10.5772/intechopen.91697*

for weight loss in obesity with BMI between 30 and 40 kg/m<sup>2</sup>

tion, gastric ulcer, and gastric perforation (non-exhaustive list).

Overall, Orbera™ Intragastric Balloon System is relatively safe and has a strong effectiveness. The device was approved by the FDA in August 2015. It is indicated

lifestyle recommendations, in subjects who failed to respond to diet, exercise, and behavior change. It is contraindicated in several conditions including pregnancy, non-adult subjects, prior bariatric surgery, inflammatory diseases of the gastrointestinal tract, upper gastrointestinal bleeding conditions, and liver deficiency (non-exhaustive list). Complications include balloon migration, intestinal obstruc-

Obalon Balloon System (Obalon Therapeutics, Inc.) is a swallowable balloon made of nylon and polyethylene contained within a gelatin capsule (attached to a thin inflation catheter) that is taken orally. The correct position of the capsule is confirmed with fluoroscopy. The capsule disintegrates in the stomach and releases the balloon. The balloon is filled with air (250 cc of nitrogen and sulfur hexafluoride gas mixture). Up to three balloons can be placed in the same session or sequentially over a 6-month period (**Figure 3**). The procedure is minimally invasive and can be performed in an outpatient setting without endoscopy. The balloon is removed endoscopically after 6 months. By occupying gastric volume, Obalon Balloon System causes early satiety and a decrease in food intake with subsequent

In the pivotal study, 387 subjects (341 females, 46 males, mean BMI = 35.2 kg/m2

were randomized into Obalon Balloon System (n = 198) or control (sham capsule, n = 189) arms for 6 months. At Month 6, the eligible control arm subjects were permitted to crossover and receive Obalon Balloon System for 6 months. All subjects were given lifestyle recommendations. The co-primary effectiveness endpoints, assessed in the mITT population at Month 6, were a significantly greater weight loss in Obalon Balloon System arm compared to control arm (super-superiority) and the responder rate at 5% weight loss in Obalon Balloon System arm. Device-related safety analysis also included 138 subjects who switched at Month 6 from control to Obalon Balloon System. At Month 6, the weight losses were 6.6 and 3.4% in Obalon Balloon System and control arms, respectively, and the responder rate at 5% weight loss in Obalon Balloon System arm was 62.1%. The study met both co-primary effectiveness endpoints. Most device-related AEs were of gastrointestinal origin (mainly abdominal pain and nausea/vomiting, mild in the majority of cases), observed in

*Obalon Balloon System (Obalon Therapeutics, Inc.—Picture downloaded from the internet).*

, in conjunction with

)

#### *Anti-Obesity Medical Devices DOI: http://dx.doi.org/10.5772/intechopen.91697*

*Weight Management*

portal hypertension, and severe cardiopulmonary diseases (non-exhaustive list). Complications include proximal gastric enlargement, erosion or migration of the

Orbera™ Intragastric Balloon System (Apollo Endosurgery, Inc.) is a balloon made of silicone placed endoscopically in the stomach (**Figure 2**). The balloon is filled with saline mixed with methylene blue (450–700 mL). The methylene blue is a marker for balloon dysfunction. In case of balloon rupture, the methylene blue will be systematically absorbed and change the color of urine to blue. The procedure is minimally invasive and can be performed in an outpatient setting. The balloon is removed endoscopically after 6 months. By occupying gastric volume, Orbera™ Intragastric Balloon System causes early satiety and a decrease in food intake with

In the pivotal study, 255 subjects (229 females, 26 males, mean BMI = 35.3

*Orbera™ Intragastric Balloon System (Apollo Endosurgery, Inc.—Picture downloaded from the internet).*

) were randomized into Orbera™ Intragastric Balloon System (n = 125) or control (no intragastric intervention, n = 130) arms for 6 months and 6 months follow-up after Orbera™ Intragastric Balloon System removal. Safety analysis also included an additional 35 run-in, non-randomized subjects who received Orbera™ Intragastric Balloon System. All subjects were given lifestyle recommendations. The co-primary effectiveness endpoints, assessed in the modified intentionto-treat (mITT) population at Month 9, were the excess weight loss in Orbera™ Intragastric Balloon System arm and a significantly greater weight loss in Orbera™ Intragastric Balloon System arm compared to control arm. At Month 9, the excess weight loss was 26.5% in Orbera™ Intragastric Balloon System arm, and the weight losses were 9.1 and 3.4% in Orbera™ Intragastric Balloon System and control arms, respectively. The study did not meet the first co-primary effectiveness endpoint but met the second co-primary effectiveness endpoint. At Month 6, the weight losses were 10.2 and 3.3% in Orbera™ Intragastric Balloon System and control arms, respectively. A total of 810 device-related AEs was observed (mainly nausea/vomiting, gastroesophageal reflux, and abdominal pain, mild or moderate in the majority of cases). Fourteen device- or procedure-related SAEs were observed,

band, and leaks of the band system (non-exhaustive list).

*7.1.2 Gastric space-occupying devices*

*7.1.2.1 Orbera™ Intragastric balloon system*

subsequent weight loss [8, 11, 13, 14].

mainly device intolerance but no death.

kg/m<sup>2</sup>

**244**

**Figure 2.**

Overall, Orbera™ Intragastric Balloon System is relatively safe and has a strong effectiveness. The device was approved by the FDA in August 2015. It is indicated for weight loss in obesity with BMI between 30 and 40 kg/m<sup>2</sup> , in conjunction with lifestyle recommendations, in subjects who failed to respond to diet, exercise, and behavior change. It is contraindicated in several conditions including pregnancy, non-adult subjects, prior bariatric surgery, inflammatory diseases of the gastrointestinal tract, upper gastrointestinal bleeding conditions, and liver deficiency (non-exhaustive list). Complications include balloon migration, intestinal obstruction, gastric ulcer, and gastric perforation (non-exhaustive list).
