*7.2.2.1 Plenity™*

*Weight Management*

(non-exhaustive list).

*7.2.1.1 SmartByte Device*

related SAEs were observed.

**7.2 Weight-management devices**

*7.2.1 Oral removable palatal space-occupying devices*

control arms, respectively. Device- or procedure-related AEs were observed in 93 subjects (83.8%, mainly peristomal granulation tissue, abdominal pain, and nausea/ vomiting, mild in the majority of cases). Device- or procedure-related SAEs were

Overall, AspireAssist® is relatively safe and has a strong effectiveness. The device was approved by the FDA in June 2016. It is indicated for weight loss in

ommendations, in subjects who failed to respond to non-surgical weight-loss therapy. It is contraindicated in several conditions including pregnancy, non-adult subjects, upper gastrointestinal bleeding conditions, chronic abdominal pain, severe cardiopulmonary diseases, and eating disorders (non-exhaustive list). Complications include skin irritation, infection, and electrolyte abnormalities

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

ized 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 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

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

, in conjunction with lifestyle rec-

) were random-

observed in four subjects (3.6%), including peritonitis but no death.

obesity with BMI between 35 and 55 kg/m<sup>2</sup>

**248**

**Figure 6.**

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 subsequent weight loss [17].

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 observed.

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 overweight and obesity with BMI between 25 and 40 kg/m<sup>2</sup> , in conjunction with lifestyle recommendations. It is contraindicated in pregnancy, non-adult subjects, and history of allergic reaction to the components of Plenity™ capsule. No relevant complications have been reported.

**Figure 7.** *Plenity™ (Gelesis, Inc.—Picture downloaded from the internet).*

Comparative effectiveness of the above anti-obesity medical devices is reported in **Table 2**.


#### **Table 2.**

*Approved/cleared anti-obesity medical devices in the USA ranked by extent of total body weight loss in pivotal studies.*

Relevant complications (non-exhaustive list), some being very rare, of the above anti-obesity medical devices are reported in **Table 3**.


#### **Table 3.**

*Relevant complications of the approved/cleared anti-obesity medical devices in the USA in pivotal studies.*

#### Cost of the above anti-obesity medical devices is reported in **Table 4**.


**251**

**Author details**

Hassan M. Heshmati

**Conflict of interest**

Endocrinology Metabolism Consulting, LLC, Anthem, AZ, USA

surgery). Their use should always be combined with lifestyle changes.

The author received honorarium for consultancy from Gelesis, Inc.

© 2020 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/ by/3.0), which permits unrestricted use, distribution, and reproduction in any medium,

\*Address all correspondence to: hassanheshmati@yahoo.com

provided the original work is properly cited.

*Anti-Obesity Medical Devices*

Garren Gastric Bubble).

**approval**

**11. Conclusions**

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

countries (e.g., Epitomee Device [18]).

been challenged for safety reasons [8, 11–14].

play a major role in the management of obesity.

**10. Over-the-counter anti-obesity medical devices**

products (e.g., NozNoz, slow control fork, slipper genie).

**8. Anti-obesity medical devices withdrawn from the market in the USA**

**9. Anti-obesity medical devices under investigation or pending** 

Several anti-obesity medical devices have been withdrawn by the manufacturers from the market in the USA after approval by the FDA (e.g., Maestro Rechargeable System, Realize Adjustable Gastric Band, ReShape Integrated Dual Balloon System,

Several anti-obesity medical devices are currently in development in different

EndoBarrier® has obtained a CE mark in the EU but its approval in the USA has

A variety of anti-obesity medical devices are available as over-the-counter

Anti-obesity medical devices represent a heterogenous family of devices in terms of presentation, usage/administration, mechanism of action, effectiveness, safety, regulation, availability, and cost. They offer an attractive approach in managing obesity. Anti-obesity medical devices are positioned to bridge the gap between more conservative treatments (e.g., lifestyle) and more aggressive interventions (e.g., bariatric

Considering the large market size of obesity treatment and the small percentage of subjects treated with drugs or bariatric surgery, anti-obesity medical devices can

#### **Table 4.**

*Cost of the approved/cleared anti-obesity medical devices in the USA.*

*Weight Management*

in **Table 2**.

**Table 2.**

*studies.*

Comparative effectiveness of the above anti-obesity medical devices is reported

**Medical device Treatment duration Total body weight loss** Lap-Band® 36 months 18.0% AspireAssist® 12 months 12.1% Orbera™ Intragastric Balloon System 6 months 10.2% TransPyloric Shuttle 12 months 9.5% Obalon Balloon System 6 months 6.6% Plenity™ 6 months 6.4% SmartByte Device 4 months 1.7%

Relevant complications (non-exhaustive list), some being very rare, of the above

*Approved/cleared anti-obesity medical devices in the USA ranked by extent of total body weight loss in pivotal* 

Lap-Band® 36 months Proximal gastric enlargement, band erosion or

AspireAssist® 12 months Skin irritation, infection, electrolyte abnormalities

Obalon Balloon System 6 months Balloon migration, intestinal obstruction, gastric

**Relevant complication**

migration, system leaks

6 months Balloon migration, intestinal obstruction, gastric ulcer, gastric perforation

ulcer, gastric perforation

Cost of the above anti-obesity medical devices is reported in **Table 4**.

**Medical device Average cost (Range)** Lap-Band® \$15,000 (\$10,000–\$30,000) AspireAssist® \$10,000 (\$7,000–\$13,000) Orbera™ Intragastric Balloon System \$6,000 (\$3,000–\$9,000) TransPyloric Shuttle To be determined Obalon Balloon System \$8,000 (\$6,000–\$9,000) Plenity™ \$100/month SmartByte Device \$500

*Relevant complications of the approved/cleared anti-obesity medical devices in the USA in pivotal studies.*

anti-obesity medical devices are reported in **Table 3**.

Plenity™ 6 months None

*Cost of the approved/cleared anti-obesity medical devices in the USA.*

**duration**

TransPyloric Shuttle 12 months Device impaction, gastric ulcer

SmartByte Device 4 months Choking on food, mouth soreness

**Medical device Treatment** 

Orbera™ Intragastric Balloon

System

**Table 3.**

**250**

**Table 4.**
