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Orbera 365 balloon
A more recently available type of the Orbera balloon system, Orbera 365 (Boston Scientific, Marlborough,
[48]
MA), is designed to remain in situ for 12 months . One study showed no significant difference in %TBWL
in patients who underwent IGB placement for 6 months with Orbera or 12 months with Orbera 365 (15.3%
vs. 14.7%, P = 0.7) .
[48]
ReShape balloon system
The ReShape system features two balloons that are filled with saline (450 mL) and methylene blue dye
(450 mL) connected by a central tube with an implant duration of 6 months [Figure 2B] . The use of
[37]
methylene blue enabled early detection of balloon deflation or rupture . A retrospective study of 34
[42]
patients (mean baseline BMI of 37.1 ± 5.5 kg/m ) who underwent ReShape balloon placement reported an
2
average TBWL of 6.8% (P < 0.001) and a significant decrease in diastolic blood pressure. While nausea was
the most common complication (22.9%), one patient had a small bowel obstruction due to balloon
migration, and another experienced a bleeding gastric ulcer . This device is no longer available for unclear
[49]
reasons.
The Spatz3 adjustable balloon system
The Spatz3 is a volume-adjustable silicone balloon filled with saline and 1% methylene blue designed to
[44]
remain in situ for 8 months . Its unique feature is an extractable filling catheter that enables in situ
bidirectional volume adjustments based on patient tolerability and desired weight outcomes. The volume
may be increased to enhance weight loss, or decreased to alleviate intolerance and maximize treatment
duration [44,50] . A multicenter RCT of 288 patients found that the addition of Spatz3 therapy to lifestyle
intervention led to a significantly higher mean TBWL after 8 months compared to lifestyle intervention
alone (15% vs. 3.3%, P < 0.0001) with a 92% response rate. 80% of patients underwent volume adjustments
for weight loss or intolerance, leading to a 3.1% greater mean TBWL in patients who were adjusted .
[50]
Upward adjustment alone led to an additional 5.2% TBWL compared to no adjustment. Early removal
occurred in 17% of patients, and the most common serious adverse events included nausea (3%), vomiting
(3%), dehydration (2%), nutritional or metabolic disorders (2%), diarrhea (1%), and abdominal pain (1%)
[50]
without any mortality .
Gas-filled balloons
Obalon balloon system
The Obalon balloon system (Obalon Therapeutics, Carlsbad, CA, USA) involves a series of three thin-
walled nylon polyethylene blend balloons, each filled with 250 mL of nitrogen gas [28,42] . These three balloons
[Figure 2C] are swallowed as capsules (prior to inflation with an attached thin catheter) in sequence over
[37]
time but require endoscopic removal after six months [28,44] . A multicenter, double-blind RCT of 387 patients
found a significantly greater TBWL in patients who underwent Obalon balloon therapy compared to those
managed with lifestyle interventions alone (7.1% vs. 2.6%, P = 0.0085) at 6 months. The responder rate was
66.7% (P < 0.0001) and the treatment group maintained 88.5% of their weight loss at 48 weeks. Patients in
the treatment group experienced improvements in multiple cardiometabolic risk factors such as blood
pressure, glucose, fasting plasma total cholesterol and triglycerides. There was a 0.4% rate of severe adverse
events (one balloon deflation and a bleeding ulcer) . This system is no longer commercially available
[51]
following the company’s merger with ReShape Lifesciences.
Other existing IGBs include:
The Heliosphere® BAG: a lightweight, air-filled polymer balloon encased in a silicone shell. It was developed
to reduce the nausea and vomiting commonly caused by liquid-filled balloons, which result from their

