Clinical Update
Hundreds of patients have been treated with the EndoBarrier™ System in clinical trials in South America, Europe, and the US.
Data from early type 2 diabetes clinical trials demonstrate:
- Patients with type 2 diabetes who received the EndoBarrier System experienced a reduction in HbA1c of >2.4% points at week 28, compared to placebo group who experienced a reduction of .8% points at week 28.
Data from a multicenter, randomized weight loss trial demonstrate:
- At 12 weeks, patients treated with the EndoBarrier System (n=24) lost 13.3 kg, compared to the diet control group (n=11) who lost 5.5 kg.
Data presented at ASMBS 2009 demonstrate:
- Substantially enhanced weight loss effects of combining the EndoBarrier Gastrointestinal Liner with a new EndoBarrier Flow Restrictor were demonstrated. The EndoBarrier Flow Restrictor provides an adjustable restriction at the outlet of the stomach and is designed to delay gastric emptying, an additional mechanism which adds to the therapeutic effects of the liner.
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In this initial, single-center study of 10 morbidly obese people (body mass index between 35.8 and 47.8), participants achieved the following results over a twelve-week period during which the device was implanted (median values reported):
- Percent Excess Weight Loss (%EWL): 39.6%
- Weight Loss: 36.7 pounds (16.7 kilograms)
- Percent Total Body Weight Loss (%TBWL): 15.4%
All 10 patients completed the 12-week study. The most common side effects included mild to moderate abdominal pain, nausea and vomiting.