intragastric balloons

Product Name: BioEnterics® intragastric balloon, Heliosphere IGB system
Country: Australia (AU)

Medical Services Advisory Committee

Outcome Measure

a. Safety: Primary - major complications (migration, oesophageal/gastrointestinal obstruction or perforation); minor complications (gastric erosion, ulceration, nausea, electrolytic abnormalities), Secondary - technical failure, bursting of the balloon (p. 48)<br>b. Effectiveness: Primary - short- and long-term weight loss, BMI, waist size, skinfold thickness, fat free mass, quality of life, mortality (all cause), obesity-related co-morbidities, Secondary - technical failure (p. 63)

Body Classification

Digestive System

Device Type

Therapeutic device

Device Category

Treatment of disease

Risk Classification

IIb

Indication

obesity

ICD-10

E66

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