*7.1.2.2 Obalon Balloon System*

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 weight loss [8, 13, 14].

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

300 subjects (89.3%). Device- or procedure-related SAEs were observed in one subject (0.3%), a case of peptic ulcer disease.

Overall, Obalon Balloon System is relatively safe and has a modest effectiveness. The device was approved by the FDA in September 2016. 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, gastric diseases, and eating disorders (non-exhaustive list). Complications include balloon migration, intestinal obstruction, gastric ulcer, and gastric perforation (non-exhaustive list).

### *7.1.2.3 TransPyloric Shuttle*

TransPyloric Shuttle (BAROnova, Inc.) is a device placed endoscopically in the stomach (**Figure 4**). It is not strictly a balloon but functions like a balloon. It has two asymmetrical bulbs made of silicone connected by a flexible catheter. The procedure is minimally invasive and can be performed in an outpatient setting. The shuttle is removed endoscopically after 12 months. By creating intermittent obstruction to gastric outflow that delays gastric emptying, TransPyloric Shuttle causes early satiety and a decrease in food intake with subsequent weight loss [8, 13].

In the pivotal study, 270 subjects (252 females, 18 males, mean BMI = 36.6 kg/m2 ) were randomized into TransPyloric Shuttle (n = 181) or control (sham endoscopic procedure, n = 89) arms for 12 months. The TransPyloric Shuttle was successfully placed in 171 subjects. The study also included an additional 32 open-label subjects who received TransPyloric Shuttle. All subjects were given lifestyle recommendations. The co-primary effectiveness endpoints, assessed in the per protocol population at Month 12, were a significantly greater weight loss in TransPyloric Shuttle arm compared to control arm and the responder rate at 5% weight loss in TransPyloric Shuttle arm. At Month 12, the weight losses were 9.5 and 2.8% in TransPyloric Shuttle and control arms, respectively, and the responder rate at 5% weight loss in TransPyloric Shuttle arm was 66.8%. The study met both co-primary effectiveness endpoints. Most device-related AEs were of gastrointestinal origin (mainly nausea/ vomiting, abdominal pain, and dyspepsia, mild or moderate in the majority of

**247**

**Figure 5.**

*Anti-Obesity Medical Devices*

*7.1.3 Gastric emptying devices*

*7.1.3.1 AspireAssist®*

m2

and < 35 kg/m2

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

in obesity with BMI between 35 and 40 kg/m<sup>2</sup>

testinal nutrients with subsequent weight loss [8, 11–14].

*AspireAssist® (Aspire Bariatrics, Inc.—Picture downloaded from the internet).*

cases), observed in 200 subjects (98.5%). Device- or procedure-related SAEs were

Overall, TransPyloric Shuttle is relatively safe and has a strong effectiveness. The device was approved by the FDA in April 2019. It is indicated for weight loss

AspireAssist® (Aspire Bariatrics, Inc.) is a device attached to a percutaneous endoscopic gastrostomy tube implanted endoscopically (**Figure 5**). It allows the aspiration of gastric contents 20–30 minutes after each major meal (a meal containing more than 200 calories). Thorough chewing of food is required to facilitate aspiration with the 6-mm-diameter tube. The procedure is minimally invasive and can be performed in an outpatient setting. The device is removed when the desired body weight is reached. By allowing the removal of approximately 30% of ingested calories over 5–10 minutes, AspireAssist® causes decreased absorption of gastroin-

In the pivotal study, 171 subjects (149 females, 22 males, mean BMI = 41.6 kg/

) were randomized into AspireAssist® (n = 111) or control (no intragastric intervention, n = 60) arms for 12 months. All subjects were given lifestyle recommendations. The co-primary effectiveness endpoints, assessed in the mITT population at Month 12, were a significantly greater excess weight loss in AspireAssist® arm compared to control arm (super-superiority) and the responder rate at 25% excess weight loss in AspireAssist® arm. At Month 12, the excess weight losses were 31.5 and 9.8% in AspireAssist® and control arms, respectively, and the responder rate at 25% excess weight loss in AspireAssist® arm was 56.8%. The study met the first co-primary effectiveness endpoint but not the second co-primary effectiveness endpoint. At Month 12, the weight losses were 12.1 and 3.6% in AspireAssist® and

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, gastric diseases, and eating disorders (non-exhaustive list). Complications include device impaction and gastric ulcer (non-exhaustive list).

in the presence of one or more comorbidities, in conjunction with

or obesity with BMI between 30

observed in six subjects (3.0%), mainly device impaction but no death.

**Figure 4.** *TransPyloric Shuttle (BAROnova, Inc.—Picture downloaded from the internet).*

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

cases), observed in 200 subjects (98.5%). Device- or procedure-related SAEs were observed in six subjects (3.0%), mainly device impaction but no death.

Overall, TransPyloric Shuttle is relatively safe and has a strong effectiveness. The device was approved by the FDA in April 2019. It is indicated for weight loss in obesity with BMI between 35 and 40 kg/m<sup>2</sup> or obesity with BMI between 30 and < 35 kg/m2 in the presence of one or more comorbidities, 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, gastric diseases, and eating disorders (non-exhaustive list). Complications include device impaction and gastric ulcer (non-exhaustive list).

#### *7.1.3 Gastric emptying devices*
