The Orbera Intragastric Balloon System (B‑4800) is a single‑use, saline‑filled silicone balloon placed endoscopically into the stomach and inflated to 400–700 mL to partially occupy gastric volume, increase satiety, and delay gastric emptying as an adjunct to diet and behavior modification in adults with BMI 30–40 kg/m². The system includes the deflated balloon preloaded on a placement catheter with self‑sealing valve and dedicated filling set, and is designed for endoscopic removal at 6 months to minimize risks such as deflation and migration.
Key features
- Smooth, soft, spherical silicone balloon, saline‑filled (typical fill 400–700 mL) to induce satiety and reduce gastric capacity.
- Radiopaque self‑sealing valve and catheter markers for fluoroscopic/endoscopic visualization and controlled placement.
- Indicated for adults with BMI 30–40 kg/m² as an adjunct to supervised diet and behavior program; maximum dwell time 6 months.
- US pivotal data show significantly greater weight loss versus diet and exercise alone (≈3× more at 12 months).
- Requires upper endoscopy for both placement and removal, performed by trained physicians experienced in advanced endoscopy.
