The first endoscopically-delivered device therapy for obese patients with type 2 diabetes
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1 DIABETES WEIGHT ENDOBARRIER THERAPY The first endoscopically-delivered device therapy for obese patients with type 2 diabetes
2 Restore the metabolic health of your patients with EndoBarrier Therapy. Dual Challenge. Single Solution. The progressive nature of type 2 diabetes and obesity poses a significant and growing challenge in clinical practice. One exacerbates the other; and patients can reach a point where they no longer respond to lifestyle interventions and anti-diabetes drug therapies. In the past, this may have left them with injectable medications and surgery as their only options. Now with EndoBarrier Therapy, an adjuvant treatment option for type 2 diabetes and obesity, you can quickly restore patients to lower, more manageable glycemic levels and healthier weight. Data also suggest an improvement in cardiovascular risk factors, such as blood pressure, total cholesterol, LDL and triglycerides. 1,2,3,4 It redefines the treatment paradigm for obese, type 2 diabetes patients... For whom lifestyle changes and diabetes medications are no longer effective For whom surgery is not an option or is considered a therapy of last resort At risk for serious health consequences of Type 2 Diabetes, Obesity and Associated Cardiovascular Risk Factors Indicated for a Broad Patient Population HbA1c 7.0% with BMI 30 BMI 30 with 1 comorbidity BMI >35 Tried and failed to control their diabetes or lose weight with drugs and/or lifestyle changes Over 18 years of age Excess Weight & Cardiovascular Risk Not pregnant or planning to become pregnant
3 EndoBarrier Therapy helps An Innovative Solution EndoBarrier Therapy represents an entirely new class of therapy for the treatment of type 2 diabetes and/or obesity. * In clinical studies, it has been shown to lower blood glucose levels and reduce weight in patients unable to reach their therapeutic goals with conventional drug therapies or lifestyle changes. How EndoBarrier Works The EndoBarrier liner creates a physical barrier between ingested food and the duodenum/proximal jejunum. Clinical data suggest that EndoBarrier Therapy works by affecting key hormone levels involved in insulin sensitivity, glucose metabolism, food intake and satiety. 5 * EndoBarrier is indicated for the treatment of obese type 2 diabetes with BMI > 30 kg/m 2, or obese patients with BMI > 30 kg/m 2 with > 1 comorbidities, or obese patients with BMI > 35 kg/m 2.
4 improve type 2 diabetes and obesity at the same time. Compelling Clinical Results In clinical studies, EndoBarrier Therapy has been shown to rapidly lower blood glucose levels and promote significant weight loss. Data also suggests an improvement in cardiovascular risk factors. 1,2,3,4 Rapidly Lower Blood Glucose Mean HbA1c decreased from 8.5% at baseline to 6.7% after three months and remained relatively steady throughout 12-month treatment. (N=29) 6 Significant Weight Loss Average 17% total body weight loss in one year (N=49) 6 Improved Cardiovascular Risk Factors Significant improvement in serum lipids and blood pressure (N=49) 1,2,3 Up to 40% reduction in 10-year CV risk after 12-months, according to three different CV risk models (N=40) 4 EndoBarrier does not work for everyone and individual results may vary. In clinical studies, the most common complications were nausea, vomiting and upper abdominal pain. Other uncommon risks include infection, trauma, device migration and bleeding, any of which may result in endoscopic or surgical device removal. Weight (kg), N=49 BMI (kg/m 2 ), N=49 BMI 30 with T2D or 1 Comorbidity or BMI >35 (N=49) 6 BMI 30/with & without T2D (N=49) Mean Weight (kg) Mean HbA1c (%) p=<0.05 Blood Lipids (mmol/l), N=49 Total Cholesterol LDL Triglycerides T2D & Obesity (N=29) 6 T2D & Obesity (N=29) Weeks after implant p=< Weeks after implant A Pooled BMI Analysis > 30 with of 12-month & without Completers T2D 6 Baseline (mean) 52-week Change (mean) % Change (mean) * -16.5% * -16.5% * -0.6* -0.5* -14.9% -18.0% -17.3% Blood Pressure (mmhg), N=40 Systolic Diastolic * -9* -5.2% -10.8% * p=<0.05
5 . Multidisciplinary Approach to Patient Care EndoBarrier Therapy is offered at Treatment Centres with the clinical expertise, training, and resources to best manage EndoBarrier patients throughout their treatment. Treatment is optimised through a multidisciplinary approach involving nutritional and behavioural counseling, exercise guidance, diabetes management, a specially-trained endoscopy team and the patient s primary care physician. Learn more about referring your patients to the EndoBarrier Treatment Centre nearest you. Visit
6 1. Moura, EG, et al. Metabolic improvements in obese type 2 diabetes subjects implanted for 1 year with an endoscopically deployed duodenal-jejunal bypass liner. Diabetes Technol Ther 2012: 4 (2); Escalona A, et al. Weight loss and metabolic improvement in morbidly obese subjects implanted for 1 year with an endoscopic duodenaljejunal bypass liner. Ann Surg 2012;255(6): Cohen, RV, et al. A pilot study of the duodenal-jejunal bypass liner in low body mass index type 2 diabetes. J Clin Endo & Meta 2013;98(2):E Chilton, R., et. al., Endoscopic, Duodenal-Jejunal Bypass Liner in Obese Patients with or Without Type 2 Diabetes Lowers Incidence of Metabolic Syndrome and Improves Cardiovascular Risk. Poster presentation, EASD 2014, Vienna, Austria. 5. de Jonge, et al, Endoscopic Duodenal-jejunal Bypass Liner Rapidly Improves Type 2 Diabetes. Obesity Surg 2013; 23(9): Data on file. (GI Dynamics, Inc.) EUROPE GID Germany GmbH Prinzenallee Dusseldorf Germany Customer Service Representative HealthLink Europe B.V. De Tweeling MC s-hertogenbosch The Netherlands Tel: UNITED STATES GI Dynamics, Inc. 25 Hartwell Avenue Lexington, MA USA The GI Dynamics EndoBarrier Gastrointestinal Liner System is used for the treatment of obese type 2 diabetes with BMI > 30 kg/m 2, or obese patients with BMI > 30 kg/m 2 with > 1 comorbidities, or obese patients with BMI > 35 kg/m 2. EndoBarrier is not approved for sale in the U.S. and is limited by federal law to investigational use only in the United States. EndoBarrier is a registered trademark of GI Dynamics, Inc GI Dynamics, Inc. All rights reserved MC-0005 Rev. F.
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