GI Dynamics has taken all necessary COVID-19 precautions to ensure patient safety, which remains top priority. Patient screening for the STEP-1 pivotal trial of EndoBarrier has reopened at select sites and enrollment will be conducted according to site requirements and CDC/FDA guidelines.
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EndoBarrier® is an endoscopically delivered medical device intended to help restore healthy blood sugar levels and reduce weight.
EndoBarrier is an investigational medical device for people living with uncontrolled type 2 diabetes and obesity that is sought to bridge the gap between partially effective medications, insulin injections, and irreversible surgery.
How it Works
EndoBarrier is a thin, flexible 60 cm sleeve that is endoscopically implanted within the small intestine by a trained physician. The implant secures itself with an anchoring mechanism at the upper portion of the small intestine. Placement is performed as an outpatient procedure that does not require incisions.
Once in place, EndoBarrier conforms to the shape and movement of the intestine and may begin to work immediately by creating a physical barrier between receptors in the intestinal wall and food that has been shown to directly affect key hormone levels.
What it Does
Non-US Clinical studies have shown that EndoBarrier creates changes in gut hormones that mimic mechanisms similar to Roux-en-Y gastric bypass (RYGB)1 and reduces cardiovascular risks2 and liver fibrosis through positive clinical outcomes.
Clinical data suggests EndoBarrier improves insulin resistance and glycemic control and reduces weight in patients with type 2 diabetes and obesity.1
EndoBarrier has been shown to:
- Lower blood sugar levels (HbA1c)1, 2
- Reduce cardiovascular risk2
The most commonly reported complications of EndoBarrier are gastrointestinal in nature. They include nausea, vomiting, and upper abdominal pain of mild to moderate severity and are mostly prevalent in the early days and weeks following EndoBarrier placement. Uncommon risks include liver abscess, device-related bleeding, device migration, pancreatitis, or other infections, any of which may result in endoscopic or surgical removal of the device. As with all endoscopic and/or implant procedures, serious injury or death can occur.
Treatment with EndoBarrier may last up to 12 months but should not exceed 12 months.
Removal of EndoBarrier is conducted through an endoscopic outpatient procedure under general anesthesia.
Interested in joining the STEP-1 Trial?
GI Dynamics is currently enrolling patients for Stage 1 of its STEP-1 clinical study of EndoBarrier® in the United States. Learn more if you or someone you know are interested in participating in the study and would like to see if you qualify to join.
EndoBarrier is limited by Federal (US) Law to investigational use only and is not for sale in any geography.
1Diabetes Care, American Diabetes Association journal, May 2018, “Effect of the Duodenal-Jejunal Bypass Liner on Glycemic Control in Patients with Type 2 Diabetes with Obesity: A Meta-analysis with Secondary Analysis on Weight Loss and Hormonal Changes.” Pichamol Jirapinyo et al., Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, MA.
2 ADA 76th Scientific Sessions, June 2016, “The Effect of 1-Year’s Endoscopic Proximal Intestinal Exclusion Using EndoBarrier on 10-Year Cardiovascular Risk in Type 2 Diabetes.” Robert E. Ryder et al., Sandwell and West, Birmingham Hospitals NHS Trust.