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Gastrointestinal liner

EndoBarrier gains European approval for 12-month insertion

Clinical trials involving over 300 patients have shown clinically significant EWL.
Success in trials clears way for long-term insertion in a treatment setting
12-month study leads to mean absolute weight loss of 22.5kg (46.3% EWL).

The EndoBarrier, a non-surgical therapy to treat type 2 diabetes and obesity, has received European CE mark approval for up to 12 months of treatment with the device. The product has already received CE mark approval for three and six months of treatment. Through its commercial partner, Elemental Healthcare, GI Dynamics has also announced the launch of the EndoBarrier in the UK.

“This new procedure is pioneering in that it works as a metabolic regulator directly treating type 2 diabetes and associated weight-gain, giving patients a chance to drastically improve their condition,” said Mr Alberic Fiennes, consultant bariatric surgeon at St Anthony's Hospital in Surrey and past-President of the British Obesity and Metabolic Surgical Society.

“I was excited when I first heard about EndoBarrier and impressed at the results produced by clinical studies that showed that as early as the first week post procedure, patients can experience a significant effect on their diabetes.”

The EndoBarrier is suitable for patients who have type 2 diabetes with a BMI of 30 to 50. It is initially being offered to private patients at St Anthony’s Hospital in Surrey and is hoped to become available on the National Health Service in due course, following trials at three NHS hospitals that have been designated Centres of Excellence: Imperial College St Mary’s Hospital, Southampton University Hospital and Trafford General Hospital, Manchester.

Clinical trials involving more than 300 patients have demonstrated the significant weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner. In fact, the EndoBarrier has been clinically proven to lower HbA1c levels (data presented at Digestive Disease Week 2010) and achieve weight loss of more than 20.0% of total body weight during 12 months of treatment (data presented at the International Federation for Surgery of Obesity and Metabolic Disorders [IFSO] 2010 World Congress, and Obesity 2010: 28th Annual Scientific Meeting of The Obesity Society).

“We believe the EndoBarrier, as part of a multidisciplinary approach, has the potential to change the treatment paradigm for type 2 diabetes and weight problems.” Dr Julian Teare

The EndoBarrier procedure is quick, incisionless and reversible, and many patients often go home the day of the procedure. In recent clinical trials, there have been no serious adverse events; the most common potential side effects include pain, nausea and vomiting, which generally resolves in the first two weeks of treatment.

“We believe the EndoBarrier, as part of a multidisciplinary approach, has the potential to change the treatment paradigm for type 2 diabetes and weight problems,” said Dr Julian Teare, a consultant gastroenterologist, Imperial College, London, and principal investigator of the NHS trial. “Based on the data to-date and its unique profile as a non-surgical and non-pharmaceutical treatment option, the EndoBarrier appears to provide many of the benefits of gastric bypass surgery through an endoscopic approach. We are delighted to be among the first in Europe to have access to the EndoBarrier as a new treatment option in our fight against these epidemics.”

Clinical data

The data presented at IFSO (and published in the Annals of Surgery) was from a clinical trial designed to examine the safety and efficacy of the EndoBarrier in obese patients over 12 months. 

Initially, 41 patients were included and 30 underwent sleeve implantation. Eleven patients served as a diet control group, with all patients following the same low-calorie diet during the study period.

26 devices were successfully implanted. In four patients, implantation could not be achieved and four devices were explanted prior to the initial protocol end point because of migration (1), dislocation of the anchor (1), sleeve obstruction (1), and continuous epigastric pain (1). The remaining patients all completed the study.

Mean procedure time was 35 minutes (range: 12–102 minutes) for a successful implantation and 17 minutes (range: 5–99 minutes) for explantation, with no reports of procedure related adverse events. 

Initial mean BMI was 48.9 and 47.4 kg/m2 for the device and control patients, respectively. At 12 months, mean absolute weight loss was 22.5 kg (49.5 lbs), or 20.0% (p=<0.0001) and mean excess weight loss (EWL) of 46.3%. Type 2 diabetes mellitus was present at baseline in eight patients of the device group and improved in seven patients during the study period (lower glucose levels, HbA1c, and medication requirements). 

Patients also experienced the following improvements in key cardiovascular risk factors with a reduction in total cholesterol levels from 196.5mg/dL at baseline to 161.0mg/dL (p=<0.0001) and a reduction in diastolic blood pressure from 84.8mmHg at baseline to 71.2mmHg (p=<0.0001).

The study authors concluded that the EndoBarrier is a feasible and safe non-invasive device with excellent short-term weight loss results. The device also has a significant positive effect on type 2 diabetes mellitus. Long-term randomized and sham studies for weight loss and treatment of diabetes are necessary to determine the role of the device in the treatment of morbid obesity.

“We now have data demonstrating the safety and efficacy of 12 months of EndoBarrier therapy in clinically obese patients and the impact this treatment approach has on related health issues such as hypertension, dyslipidemia and metabolic syndrome," commented Dr Alex Escalona, Department of Digestive Surgery, Pontificia Universidad Católica de Chile, Santiago, Chile, member of GI Dynamics' scientific advisory board and lead investigator of the study.

"We have previously reported notable HbA1c results achieved in patients with type 2 diabetes after nine months of treatment, and now a subset of our 12-month data in obese patients with type 2 diabetes reinforces the significant opportunity for EndoBarrier to provide a new, non-surgical solution for the treatment of type 2 diabetes." 

"At a time when physicians are seeking alternatives to pharmaceutical and surgical interventions for obesity and type 2 diabetes, these 12-month data are further support for the market potential of EndoBarrier. The European approval for 12 months of EndoBarrier therapy to treat type 2 diabetes and obesity is another key milestone for GI Dynamics as we launch the product in the UK,” said Stuart A. Randle, CEO of GI Dynamics.

“The data presented at IFSO demonstrate the significant potential for EndoBarrier to offer a much needed alternative to traditional interventions such as pharmaceutical treatments and surgery. We look forward to training additional centres in Europe over the next year and making the EndoBarrier available more broadly in the near future.”

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