GI Dynamics' CE mark for intestinal liner suspended

CE mark showing construction lines
GI Dynamics' EndoBarrier device has hit a couple of snags on its route to FDA approval, including the termination of a pivotal trial and the suspension of its CE mark.

GI Dynamics announced Thursday that the CE mark for its intestinal liner was suspended. The device is designed for people whose diabetes medications no longer work, or who are at risk of complications from diabetes and obesity.

The CE mark was suspended due to “nonconformances” in its quality management system for the EndoBarrier device, according to a statement.

“This action does not call the safety and efficacy of EndoBarrier into question and this action does not constitute a recall,” said CEO Scott Schorer, in the statement. “We are working swiftly to address issues within our quality management system that were detailed in a corrective action report from SGS; we will have these nonconformances resolved and have our CE Mark reinstated as quickly as possible.”

The EndoBarrier is a flexible, tube-shaped liner that forms a shield between food and part of the intestinal wall. This lets food bypass the duodenum in a nonsurgical alternative to gastric bypass surgery.

The company has shipped enough devices to avoid an interruption in service, according to the statement. And all patients implanted with an EndoBarrier “may continue treatment” under normal monitoring and evaluation by their healthcare professional, the company said.

GI Dynamics brought on Schorer in spring last year. Since then, the company has been “working diligently to address these and other issues.”

“We hired a chief compliance officer with experience in these matters as well as quality and regulatory experts to help us address the issues while maintaining compliant surveillance and vigilance,” Schorer said. “We have made significant progress over the past year and are focused on continuous improvement to the quality management system.”

The company’s pivotal trial of the device was halted in 2015 due to a higher-than-normal rate of hepatic abscess, which can be fatal. Later that year, GI Dynamics laid off 25 employees in a bid to save cash. The following June, it reported the final data from the terminated trial—the rate of hepatic abscess was five times that of implanted devices outside the U.S.