*7.1.1.1 Lap-Band®*

*Weight Management*

comparison to the USA.

studies in the Japanese population).

**6.3 Other countries**

Since its formation in 1993, the European Union (EU), currently a group of 27 countries (after the recent removal of the United Kingdom), has established rules for the approval of medical devices. Anti-obesity medical devices are regulated under directive 93/42/EC. There are four regulatory classes of medical devices: Class I (low risk), Class IIa (low-moderate risk), Class IIb (moderate-high risk), and Class III (high risk). Each member country has a regulatory entity called Competent Authority (CA). The CA certifies/notifies entities called Notified Bodies (NBs) in each country. The NBs are private, for-profit companies responsible for conformity assessment and CE (Conformité Européenne) mark. There are over 50 NBs in the EU. The NBs contract with the manufacturers to supply the CE mark and the approval is based on safety and performance. Clinical effectiveness is not a requirement. An anti-obesity

medical device with a CE mark can be marketed in any EU member country.

Several countries accept the FDA approval/clearance or the CE mark.

Several anti-obesity medical devices have been approved/cleared in the USA, in the EU, and in other countries. Some devices have been approved first in the EU before being approved several years later in the USA. This section focuses on anti-

Below are the anti-obesity medical devices approved/cleared in the USA (**Table 1**). Their use should always be in conjunction with lifestyle recommenda-

Lap-Band® June 5, 2001 Weight-loss device (BMI ≥ 35 kg/m2

AspireAssist® June 14, 2016 Weight-loss device (BMI 35–55 kg/m2

Obalon Balloon System September 8, 2016 Weight-loss device (BMI 30–40 kg/m2

TransPyloric Shuttle April 16, 2019 Weight-loss device (BMI 30–40 kg/m2

SmartByte Device May 18, 2017 Weight-management device (BMI 27–35 kg/m2

Plenity™ April 12, 2019 Weight-management device (BMI 25–40 kg/m2

August 5, 2015 Weight-loss device (BMI 30–40 kg/m2

)

)

)

)

)

)

)

**7. Approved/cleared anti-obesity medical devices**

**Medical device Approval date Indication**

*Approved/cleared anti-obesity medical devices in the USA ranked by approval date.*

obesity medical devices regulated in the USA.

tions on diet and exercise.

Orbera™ Intragastric Balloon

System

In the EU, the approval process is more flexible, faster, and less expensive in

Other countries have different regulatory procedures. The approval process has varying degrees of sophistication and challenges. In Japan for example, the application is processed by the Pharmaceutical and Medical Device Agency (PMDA). Although the Japanese market is very attractive for foreign manufacturers, the approval process is complicated, long, and expensive due to multiple factors (e.g., lack of translated documents from Japanese, need to perform specific and costly

**6.2 Europe**

**242**

**Table 1.**

Lap-Band® (BioEnterics Corporation) is an adjustable silicone band placed laparoscopically around the proximal stomach immediately below the gastroesophageal junction and attached to a subcutaneous reservoir (**Figure 1**). The level of pressure is adjusted by varying the amount of fluid that is inserted into the band. The technique is reversible, has low procedural risk, and can be performed in an outpatient setting. Lap-Band® can be revised and/or replaced as needed. The pressure imposed to the proximal stomach causes early satiety and a decrease in food intake with subsequent weight loss [8].

In the pivotal study, 292 subjects (247 females, 45 males, mean BMI = 47.4 kg/m2 ) were implanted with Lap-Band® and had follow-up evaluations for 36 months. The primary effectiveness endpoint, assessed in the per protocol population at Month 36, was the excess weight loss. Safety analysis also included an additional seven subjects who previously received a similar device. At Month 36, the excess weight loss was 36.2%, relatively stable over the previous 18 months (the weight loss was 18.0%). AEs were observed in 266 subjects (89.0%). Most AEs were of gastrointestinal origin (mainly nausea/vomiting, gastroesophageal reflux, and abdominal pain, mild in the majority of cases). Serious AEs (SAEs) were observed in 16 subjects (5.4%), mainly port leakage and 2 deaths (unrelated to device).

Overall, Lap-Band® is relatively safe and has a strong effectiveness. The device was approved by the FDA in June 2001. It is indicated for weight loss in severe obesity with BMI ≥ 40 kg/m<sup>2</sup> or obesity with BMI ≥ 35 kg/m2 in the presence of one or more severe 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, inflammatory diseases of the gastrointestinal tract, upper gastrointestinal bleeding conditions,

**Figure 1.** *Lap-Band® (BioEnterics Corporation—Picture downloaded from the internet).*

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