GI Dynamics has lost its right to sell its EndoBarrier device in the European Union under a CE mark. The company reported this week that its notified body SGS United Kingdom has withdrawn the CE Certificate of Conformity for EndoBarrier as of Nov. 12.
The company first received word in May that its CE mark was being suspended pending resolution of nonconformances related to ISO 13485 compliance. GE Dynamics said it has been working to address the issues raised by SGS.
The company said it is considering its options, including grounds for appeal of the decision, and that it has reached out to SGS to clarify certain procedural and substantive matters relating to the notice.
The EndoBarrier is designed to treat obese patients with Type 2 diabetes. The device creates a barrier between food and the wall of the small intestine and thereby changes metabolic pathways by controlling how food moves through the digestive system. The effects are supposed to be similar to gastric bypass surgery, but without the surgical procedure and hospital stay. The idea behind the device is that preventing food from coming into contact with the intestinal wall may alter the activation of hormonal signals that originate in the intestine, thus mimicking the effects of a Roux-en-Y gastric bypass procedure without surgery.
GI Dynamics has faced several setbacks in recent years. In March 2015, FDA halted the company's U.S. pivotal ENDO trial after four cases of hepatic abscess were found among the 325 patients enrolled in the trial. Hepatic abscess is a bacterial infection of the liver that needs immediate treatment.
The company had to cut its headcount by 48% to 36 in 2015 after the U.S. trial was halted.
Prior to that, GI Dynamics had to stop shipment for a while in late 2014, and received an advertising complaint in Australia.
GI Dynamics put a new management team in place last spring to address these and other issues. The Lexington, MA-based company said it hired a chief compliance officer with experience in these matters as well as quality and regulatory experts to help it address the issues while maintaining compliant surveillance and vigilance.