Medical device maker GI Dynamics (ASX:GID) touted newly published clinical trial data demonstrating that its EndoBarrier gastrointestinal implant can help control blood sugar levels as well as lower cholesterol in patients with Type II diabetes who are only "mildly obese."
"We are pleased with the results from this initial study evaluating EndoBarrier Therapy use in people living with type 2 diabetes who have a lower BMI," president & CEO Stuart Randle said in prepared remarks. "Our launch efforts in our current target market of obese people with type 2 diabetes are going very well, and we believe the lower BMI population represents an exciting market expansion opportunity going forward."
Researchers implanted 20 patients with the EndoBarrier device, a plastic sleeve designed to line the gut and prevent the absorption of food.
Of the 16 that completed the 1-year follow-up, most achieved HbA1c blood sugar levels of less than or equal to 7.0 by the 6-month mark, according to a press release. Just one week after treatment the patients’ average fasting plasma glucose levels changed from 207 ± 61 mg/dL at baseline to 139 ± 37 mg/dL.
"Diabetes is a challenging disease to effectively manage and there is a great need for new approaches to help patients achieve metabolic control," researcher Dr. Ricardo Cohen said in prepared remarks. "These findings suggest and support further consideration of EndoBarrier Therapy as an effective adjuvant treatment option for patients with type 2 diabetes and lower BMIs."
Earlier studies demonstrated that the EndoBarrier helps control blood sugar levels and induce weight loss of up to 20% in a year. The device won CE Mark approval in the European Union in 2010 and hit the market in Australia the next year.
EndoBarrier has investigational device approval in the U.S., and last month GI Dynamics launched a U.S. clinical trial that the company hopes to use to support a premarket approval application with the FDA. The Lexington, Mass.-based company hopes to put a PMA application before the federal watchdog agency "in late 2015," Randle told MassDevice.com in January.
