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| The French government has signed on to sponsor a cost-effectiveness study of GI Dynamics' EndoBarrier.--Courtesy of GI Dynamics |
As GI Dynamics ($GID) works toward FDA approval for EndoBarrier, the French government has agreed to fund a new study of the anti-obesity device to help secure reimbursement.
France's Ministry of Social Affairs and Health will put up about $1.5 million to bankroll a two-year study of 174 patients around the country, charting the cost-effectiveness of EndoBarrier versus conventional treatment for obesity.
The device, an endoscopically implanted tube that separates food from the intestinal wall, proved in previous studies to dramatically reduce blood sugar levels in patients and spur 20% weight loss in the first year after implantation. It has been on the market in Europe since winning a CE mark in 2010, and the latest trial gives GI Dynamics a chance to demonstrate the savings the device can provide payers, the company said.
Like much of the world, France is facing a rise in rates of obesity and metabolic diseases, leading to increased risk of kidney disease, cardiovascular disease and stroke, lead study investigator François Pattou said.
"New approaches like EndoBarrier therapy, which improves blood sugar and aids weight loss at the same time, represent an important advancement in the management of these diseases," Pattou said in a statement.
For GI, the study could help it significantly expand EndoBarrier's adoption in Europe, and with France picking up the bill the company can make its case to physicians and payers without added costs. Meanwhile, in the U.S., the company of a pivotal trial to win FDA approval, studying EndoBarrier's safety and effectiveness in 500 obese patients with Type 2 diabetes. GI expects to file with the agency by 2015, CEO Stuart Randle has said.
- read the announcement