About Our Product
The ReShape intragastric balloon is designed to occupy space in the stomach to create a sensation of satiety or fullness. The delivery system is a long insertion catheter with the deflated balloons attached to the end. The balloons are inserted through the mouth, and filled with saline once it is placed in the stomach. The ReShape intragastric balloon is designed to fit comfortably in the stomach while maximally filling the stomach area.
The ReShape intragastric balloon is comprised of two balloons attached to each other by a flexible tube. Each balloon has independent channels so that unintentional leaks or deflation in one balloon are designed not to impact the other balloon. The device is used in conjunction with diet and exercise.
ReShape Medical has obtained CE Mark and ISO certification for the ReShape intragastric balloon, and has initiated clinical investigations outside the United States. US studies are being planned. The ReShape system is not cleared by the US Food and Drug Administration (FDA) and is not available for commercial use.
