Currently, the most common treatment for Type 2 diabetics and obese patients is bariatric surgery, and more specifically Roux-en-Y gastric bypass (RYGB), with diabetes remission rates of approximately 80%.
In RYGB procedure the small intestine is re-arranged to create a bypass of the duodenum and proximal jejunum. As a result, the digested food pass directly from the stomach into the distal jejunum while the gastric juices, bile, and pancreatic exocrine products enter duodenum and flow onward to the distal jejunum. In this way, the undigested food is mixed with bile, pancreatic and gastric juices distally to the duodenum.
The gastroduodenal sleeve utilizes the same malabsorption mechanism as the RYGB procedure to provide an equivalently effective treatment while eliminating the major risks of such surgical procedure. The GDS, positioned in the proximal small intestine, serves as the barrier that prevents food from contacting the intestinal walls and effectively creates bypass of this section of the small intestine.
The gastroduodenal sleeve is made from a polyurethane-silicone based co-polymer, which provides great flexibility, mechanical strength and durability, ideal for the harsh gastric environment over long indwelling period.
The sleeve is fixated to its intended position using intragastric anchor. The anchor has no tissue-piercing elements in order to prevent damage of adjacent tissues. It is positioned in the stomach and utilizes the natural structure of the gastrointestinal tract, with the restriction provided by the pyloric valve, to prevent migration of the device.
The device is inserted endoscopically via a unique, easy-to-operate delivery system.