GI Dynamics announced the clinical results of EndoBarrier Gastrointestinal Liner with EndoBarrier Flow Restrictor at the 26th annual meeting of the American Society for Metabolic and Bariatric Surgery (ASMBS). EndoBarrier Gastrointestinal Liner plus EndoBarrier Flow Restrictor provided enhanced weight loss effects in study.
In this study the 10 morbidly obese people over a period of twelve-weeks produced 39.6% percent excess weight loss, 36.7 pounds weight loss and 15.4% percent total body weight loss.The most common side effects included mild to moderate abdominal pain, nausea and vomiting.
“These results are unparalleled for a non-surgical treatment for obesity,” stated Alex Escalona, M.D., Department of Digestive Surgery, Pontificia Universidad Católica de Chile, Santiago, Chile and lead investigator for the pilot study. “Like the United States, Chile is struggling with a growing epidemic of obesity and related metabolic disorders and life-threatening conditions. Traditionally, non-surgical treatment approaches have proven insufficient for the morbidly obese, but these data suggest we may have an effective new option to offer these patients. Based on the excellent results I observed in this pilot study, I believe the combination device may offer hope for patients battling significant weight loss needs and associated co-morbidities, and clearly deserves further study in longer-term, controlled clinical trials.”
Earlier the EndoBarrier Gastrointestinal Liner produced dramatic weight loss in more than 250 patients in clinical trails. The present data suggest that the combination of the EndoBarrier Gastrointestinal Liner with the EndoBarrier Flow Restrictor could enhance the effectiveness of the liner by nearly doubling the amount of weight loss achieved by using the liner alone. The preclinical data was presented in april at the Society of American Gastrointestinal and Endoscopic Surgeons 2009 Annual Meeting.
“We are very pleased with the results seen in this pilot study and the increased effect on weight loss achieved by the combination of the EndoBarrier Gastrointestinal Liner with the EndoBarrier Flow Restrictor,” said Stuart A. Randle, chief executive officer of GI Dynamics. “We believe that the combination of these devices impacts weight loss through distinct mechanisms of action and may truly represent a breakthrough in non-surgical treatment of type 2 diabetes and obesity. GI Dynamics is conducting ongoing clinical studies investigating the synergistic effects of the combined devices. Our platform is well positioned to deliver a portfolio of devices that will allow physicians to choose the most appropriate non-surgical therapy for each patient’s individual weight loss goals and glycemic control needs.”