*7.2.1.1 SmartByte Device*

SmartByte Device (Scientific Intake) is an oral device occupying space on the upper palate. It includes a temperature-recording sensor to monitor usage (**Figure 6**). It is worn in mouth during meal consumption. The device is renewed every 12 months. By creating limited bite size and slower eating, SmartByte Device causes a decrease in food intake with subsequent weight loss [16].

In the pivotal study, 173 subjects (BMI between 26 and 36 kg/m2 ) were randomized into SmartByte Device (n = 102) or control (no oral intervention, n = 71) arms for 4 months. All subjects were given lifestyle recommendations. The primary effectiveness endpoint, assessed in the ITT population at Month 4, was a greater responder rate at 5% weight loss in SmartByte Device arm compared to control arm. At Month 4, the responder rates at 5% weight loss were 20.6 and 5.6% in SmartByte Device and control arms, respectively. The study did not meet the primary effectiveness endpoint. At Month 4, the weight losses were 1.7 and 0.4% in SmartByte Device and control arms, respectively. Device-related AEs were observed in five subjects (4.9%, including two episodes of transient choking on food). No devicerelated SAEs were observed.

**249**

**Figure 7.**

*Anti-Obesity Medical Devices*

exhaustive list).

*7.2.2.1 Plenity™*

quent weight loss [17].

observed.

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

Overall, SmartByte Device is safe and has a weak effectiveness. The device was cleared by the FDA in May 2017. It is indicated to aid in weight management

with lifestyle recommendations. It is contraindicated in pregnancy and eating disorders. Complications include choking on food and mouth soreness (non-

Plenity™ (Gelesis, Inc.) is a superabsorbent hydrogel (cellulose and citric acid, forming a three-dimensional matrix) administered orally in capsules with 500 mL of water (three capsules, 20–30 minutes before lunch and dinner). The hydrogel particles hydrate up to 100 times their initial weight in the stomach and intestine (**Figure 7**). The particles mix with ingested food and create a larger volume with higher elasticity and viscosity. The particles degrade in the colon and are eliminated in the feces. By creating a larger volume with higher elasticity in the stomach and intestine, Plenity™ causes early satiety and a decrease in food intake with subse-

In the pivotal study, 436 subjects (245 females, 191 males, mean BMI = 33.8 kg/m2

were randomized into Plenity™ (n = 223) or control (sham capsule, n = 213) arms for 6 months. All subjects were given lifestyle recommendations. The co-primary effectiveness endpoints, assessed in the ITT population (multiple imputation) at Month 6, were a significantly greater weight loss in Plenity™ arm compared to control arm (supersuperiority) and the responder rate at 5% weight loss in Plenity™ arm. At Month 6, the weight losses were 6.4 and 4.4% in Plenity™ and control arms, respectively, and the responder rate at 5% weight loss in Plenity™ arm was 58.6%. The study did not meet the first co-primary effectiveness endpoint but met the second co-primary effectiveness endpoint. Most device-related AEs were of gastrointestinal origin (mainly abdominal distension, diarrhea, infrequent bowel movements, and flatulence, mild in the majority of cases), observed in 84 subjects (37.7%). No device-related SAEs were

Overall, Plenity™ is safe and has a modest effectiveness. The device was cleared by the FDA in April 2019. It is indicated to aid in weight management in

lifestyle recommendations. It is contraindicated in pregnancy, non-adult subjects, and history of allergic reaction to the components of Plenity™ capsule. No relevant

overweight and obesity with BMI between 25 and 40 kg/m<sup>2</sup>

complications have been reported.

*Plenity™ (Gelesis, Inc.—Picture downloaded from the internet).*

, in conjunction

, in conjunction with

)

in overweight and obesity with BMI between 27 and 35 kg/m<sup>2</sup>

*7.2.2 Ingested transient gastric space-occupying devices*

**Figure 6.** *SmartByte Device (Scientific Intake—Picture downloaded from the internet).*

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

Overall, SmartByte Device is safe and has a weak effectiveness. The device was cleared by the FDA in May 2017. It is indicated to aid in weight management in overweight and obesity with BMI between 27 and 35 kg/m<sup>2</sup> , in conjunction with lifestyle recommendations. It is contraindicated in pregnancy and eating disorders. Complications include choking on food and mouth soreness (nonexhaustive list).

## *7.2.2 Ingested transient gastric space-occupying devices*
