Patients implanted with GI Dynamics Inc.’s EndoBarrier device reduced their weight by 20 percent and experienced lowered risk for heart attack, according to the latest results of a clinical trial.
The Lexington, Mass.-based company announced data from a year-long study of its gastrointestinal liner at the International Federation for the Surgery of Obesity and Metabolic Disorders. The device is a non-surgical, endoscopic therapy for Type II diabetes and obesity. GI Dynamics won CE Mark approval in the European Union for the EndoBarrier late last year.
The company said the average weight of the 24 subjects in the trial, which was designed to examine the safety of the EndoBarrier at 12 months, was 244.1 pounds. They also experienced Type II diabetes, hypertension, dyslipidemia and metabolic syndrome. The mean weight loss in the cohort was 49.5 pounds, while cholesterol levels dropped from 196.5 mg/dL to 161.0 mg/dL and diastolic blood pressure went from 84.8 mmHg to 71.2 mmHg.
GI Dynamics last week signed a deal with Hungerford, England-based Elemental Healthcare for distribution of the EndoBarrier in the United Kingdom.