The pathway to obtaining pre-market approval (PMA) designation for a device that treats obesity and Type 2 diabetes from the FDA has never been clearer for GI Dynamic (Lexington, Massachusetts). After five years of developing the device, the company reports positive results of the device from a recent clinical trial.

And as an added bonus, a paper appearing in the advance online publication of the journal Obesity shows the benefits of using a removable device on animal models. The paper says dramatic effects of the removable device on blood glucose levels in this animal model suggest an important role for the duodenum (the first part of the small intestine) and jejunum (the central part of the small intestine) in the regulation of this metabolic function.

The study authors were recognized by the Obesity Society (Silver Spring, Maryland) with the Obesity Awards for Outstanding Journal Research, which recognizes exemplary research in basic, clinical, or population manuscripts published in the journal.

The study is just another piece of the puzzle that the company hopes will solidify the importance and need for such a device.

"We don't like to speculate on when the FDA will issue approval, but the device will go through the PMA pathway," CEO Stuart Randle told Medical Device Daily. "The [Endobarrier GI Liner] doesn't have CE-mark approval, but we are expecting it soon."

The Endobarrier creates a mechanical bypass of the duodenum and proximal jejunum. It allows food to pass through the device, and allows bile and pancreatic enzymes to travel outside the liner, allowing bile and gut hormones to travel around the liner without touching the food until later in the gut, thus mimicking a gastric bypass.

"One clear benefit of the device is that it doesn't carry the risk of surgery," Randle said. "It's a removable device and ... and it has a lot lower cost than surgical procedures."

In a recent clinical trial designed to examine the EndoBarrier for the treatment of Type 2 diabetes. In a single-blind, long-term study, 12 Type 2 diabetics were prospectively randomized to receive the EndoBarrier GI liner and six Type 2 diabetics received a sham endoscopy.

The primary endpoint was reduction of HbA1c (average blood glucose level over three months). Secondary endpoints included absolute weight loss, reduction in fasting glucose from baseline, improvement in post-prandial glycemic response, and reduction or discontinuation of oral hypoglycemic medications. The trial is now complete, and data are available on patients with the device for up to 11 months, GI Dynamics said.

The data show that EndoBarrier patients experienced a mean reduction of 2.9% of HbA1c glucose levels from baseline (8.9%) vs. a mean 0.76% reduction from baseline (9%) for the sham arm for an average of 31 weeks.

The company says these results support the initial findings reported at the American Diabetes Association (ADA; Alexandria, Virginia) annual meeting in June that the EndoBarrier rapidly improves glycemic control in Type 2 diabetics at one week, independent of weight loss.

Results observed in this small study with the EndoBarrier compare favorably to previously reported findings with the latest blockbuster diabetes treatment, Byetta. According to published data, patients on Byetta reported a 0.8% reduction in HbA1c from baseline (8.6%) at 30 weeks. Additionally, EndoBarrier patients experienced an average 27.5-pound weight loss in this trial by week 30.

"Our trials have varied in size, typically 10 to 30 patients," Randle said. "Our initial studies were three-month studies."

The initial concept of the Endobarrier GI liner came about in 2002 and the company received its Series A round of financing in 2003 (Medical Device Daily, July 23, 2003). The concept of the device initially came out of an incubator, Seedling Enterprises (Boston).

Since that time, more than 100 patients have been treated with the EndoBarrier device for weight loss as well as diabetes, Randle said, and the company anticipates launching larger, longer-term studies with an enhanced device design in 2009.