Good news from the obesity epidemic front! Lexington, MA based GI Dynamics has just received European CE Mark of approval to market its EndoBarrier, an endoscopically placed GI liner, for 12 months of treatment of Type 2 Diabetes and obesity. The device, well known to our readers for many years now, has been previously approved in the EU for three and six months of treatment. Furthermore, the company has just announced the official launch of its product in the UK.
From the GI Dynamics’ statement on the news:
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.
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 Centers of Excellence: Imperial College St. Mary’s Hospital, Southampton University Hospital and Trafford General Hospital, Manchester.
Press release: GI Dynamics Receives European CE Mark Approval for 12 Months of EndoBarrier™ Treatment of Type 2 Diabetes and Obesity; Announces U.K. Launch …
Flashbacks: GI Dynamics Announces Trial Data Which Shows EndoBarrier’s Efficacy in Treating Obesity; EndoBarrier Bypasses Gastric Bypass for Obesity, Diabetes Treatment; EndoBarrier May Be Helpful in Patients With Type II Diabetes; EndoBarrier, an Internal Condom, Gets Positive Results in Diabetic Clinical Trial; Eat Away, Just Don’t Digest