GI Dynamics (Lexington, Massachusetts) said it has once again struck gold in the fight for weight loss, with a new component to its EndoBarrier device.

The company reported that patients who have been fitted with the EndoBarrier Gastrointestinal Liner are seeing even more excess weight being shed with the addition of the new EndoBarrier Flow Restrictor to the device.

"With the EndoBarrier just used by itself on a patient, we see about 20% excess weight loss at six months," Jonathan Hartmann, a spokesman for GI Dynamics told Medical Device Daily from the floors of the International Federation for the Surgery of Obesity and Metabolic Disorders annual meeting in Paris. "When we combine the flow restrictor with the EndoBarrier we see nearly double the weight loss."

Hartmann and representatives from GI Dynamics are set to present results of a clinical study regarding the effectiveness of EndoBarrier with Flow Restrictor at the conference, tommorrow.

The study, which was previously highlighted in June at the 26th annual meeting of the American Society for Metabolic and Bariatric Surgery (ASMBS; Gainsville Florida), demonstrated the substantially enhanced weight loss benefits of combining the company's EndoBarrier Gastrointestinal Liner with a new EndoBarrier Flow Restrictor.

In this initial, single-center study of 10 morbidly obese people (body mass index between 35.8 and 47.8), participants achieved the following results over a twelve-week period during which the device was implanted (median values reported):

• Percent Excess Weight Loss (%EWL): 39.6%

• Weight Loss: 36.7 pounds (16.7 kilograms)

• Percent Total Body Weight Loss (%TBWL): 15.4%.

All 10 patients completed the 12-week study. The most common side effects included mild to moderate abdominal pain, nausea and vomiting.

"We have had significant clinical experience with the EndoBarrier at our obesity management center, and even when assessed relative to invasive and other noninvasive procedures, we believe the EndoBarrier platform represents a much needed new approach to reducing weight and improving blood sugar control in obese patients and patients at risk for serious metabolic disease," said Manoel Galvao Neto, MD, a lead investigator for the study."

"In particular, we are excited about the new data emerging from our ongoing clinical study in people living with Type 2 diabetes and the notable impact EndoBarrier appears to have on blood sugar control. We look forward to sharing these data later this year upon completion of the trial," he said.

The EndoBarrier Flow Restrictor provides an adjustable restriction at the outlet of the stomach and is designed to delay gastric emptying, an additional mechanism which adds to the therapeutic effects of the liner.

The EndoBarrier GI Liner, by itself creates a physical barrier that lines the intestine to keep food from coming in contact with the intestinal wall. Physicians believe this may alter the activation of hormonal signals that originate in the intestine, and may mimic the effects of a Roux-en-Y gastric bypass procedure.

However, the EndoBarrier procedure is done without the risks associated with highly invasive surgical procedures. The EndoBarrier is placed and removed endoscopically (via the mouth) without the need for surgical intervention or alteration of the patient's anatomy.

"It's the same device, but the flow restrictor has a diaphragm in the center of it with a 4 mm hole in its center," Hartmann said.

So far, clinical trials involving more than 250 patients have demonstrated the dramatic weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner.

These latest data suggest that the combination of the EndoBarrier Gastrointestinal Liner with the EndoBarrier Flow Restrictor could enhance the effectiveness of the liner by nearly doubling the amount of weight-loss achieved by using the liner alone. The clinical data is consistent with previously reported pre-clinical data from the company assessing the combination of devices in a porcine model.