October 15, 2010 -
Innovative Medical Device Offers Patients a Catalyst for Regaining Control of Diabetes and Weight; Targeted Rollout Begins with Centers of Excellence –
GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, announced that it has received European CE mark approval for the EndoBarrier, a non-surgical therapy to treat type 2 diabetes and obesity. This approval is specific to up to 12 months of treatment with the EndoBarrier; 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 United Kingdom.
Alberic Fiennes, M.D., consultant bariatric surgeon at St. Anthony's Hospital in Surrey, said: “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. 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.”
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 percent of total body weight during 12 months of treatment (data presented at the
International Federation for Surgery of Obesity and Metabolic Disorders 2010 World Congress, and Obesity 2010: 28th Annual Scientific Meeting of
The Obesity Society). 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 and the most common potential side effects include pain, nausea and vomiting, which generally resolves in the first two weeks of treatment...
GI Dynamics' Press Release -
July 25, 2011 – GI Dynamics, Inc. (GI Dynamics), a company focused on the development and commercialization of effective, non-surgical approaches for the treatment of type 2 diabetes and obesity, announced that the Australian Therapeutic Goods Administration (TGA) has approved the EndoBarrier® Gastrointestinal Liner (the EndoBarrier) for inclusion on the Australian Register of Therapeutic Goods (ARTG). The TGA has approved the use of the EndoBarrier for up to 12 months for the treatment of type 2 diabetes and obesity. With this approval, GI Dynamics will be able to commercially launch the EndoBarrier in Australia.
June 26, 2009 – 
