GI Dynamics made a lot of noise late last year about the ability of its gut-lining device to help patients struggling with weight problems and Type 2 diabetes to drop pounds while reducing their blood sugar. The device, called the EndoBarrier, is a 2-foot-long flexible sleeve that is placed in the small intestine. Recently the Lexington, MA-based startup began talking about an additional device that significantly boosted weight loss in pigs when combined with the gut liner.
The second device is a plate, made of a Teflon-like material, with a small whole that restricts the flow of partially digested food into the intestine, Andy Levine, chief technology officer at GI Dynamics, tells me. Appropriately named the “Flow Restrictor,” the device showed it could nearly double the rate of weight loss when used with the EndoBarrier, compared with using the EndoBarrier alone. The restrictive plate is intended to slow the rate at which the partially digested food empties from the stomach into the small intestine. Levine says that the devices, which are put in the body through the mouth in a 20-minute procedure, could be less invasive option than the cutting and stapling required for gastric bypass.
“It’s actually very exciting because what it starts to do is really help us to understand how these devices are working,” Levine says.
Despite showing in small studies that its gut-lining device alone could help patients drop an average of 30 pounds in three months in earlier studies, GI Dynamics does not know for sure why those patients lost weight. Levine says that the company believes but is not positive that the EndoBarrier interferes with hormonal signals that control appetite.
With the addition of the plate, the company adds a new element to induce weight loss: restriction. Restriction is a well-known means of controlling weight, and it makes patients feel full more quickly than without it. Two common ways to provide restriction are gastric bypass and gastric banding. (Gastric banding involves the use of a band that is wrapped around the intestine to slow the flow of food into the stomach.) Yet both gastric banding and gastric bypass require surgical incisions while the EndoBarrier and Flow Restrictor are inserted into the intestines through the mouth.
The plan is to seek regulatory clearance for the Flow Restrictor after the firm garners the right to market the EndoBarrier, Levine says. The EndoBarrier is now being tested in a human study to prove that it can be useful in the body for a year. Both the devices are intended to
