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FDA approval bid

EndoBarrier cleared for 12-month US pivotal trial

The pivotal trial will form a major part of GI Dynamic's attempt to get approval to market their device in the USA.
12-month, 25-centre trial approved for gastrointestinal device
Primary endpoint will evaluate device's success at resolving diabetic symptoms
Trial will help FDA assess device's suitability for marketing in the usa

The FDA has given their approval for GI Dynamics to commence a 25-centre pivotal trial in the USA for their EndoBarrier gastrointestinal liner. The trial will investigate the device’s efficacy in the treatment of obese type 2 diabetics.

The trial is an important step in the company’s bid to secure marketing approval for the EndoBarrier in the USA. Data gathered during the trial, named the ENDO Trial, will be used to support a premarket application for the device. If this is approved, GI Dynamics will be able to market the device in the USA.

“We are very pleased to now have full approval in the U.S. to commence a pivotal trial of this novel therapy,” said Stuart A. Randle, president and CEO, GI Dynamics. “We look forward to providing updates on the progress of the ENDO trial and to submitting the results for PMA approval to sell EndoBarrier in the United States.”

The ENDO trial will be a randomised, multi-centre, double-blind, sham-controlled trial, which will enroll approximately 500 people with uncontrolled diabetes at 25 sites in the United States. The trial is designed to assess improvements in patients’ diabetes during a study period of up to 12 months.

The primary endpoint for the trial is an improvement in patients’ HbA1c levels. Secondary endpoints include weight loss and improvements in some cardiovascular risk factors, like cholesterol.

Device

Implanted endoscopically, the EndoBarrier is designed to line the walls of a portion of the intestine, mimicking the malabsorptive component of a gastric bypass. The device has already been approved for marketing in Australia and the EU.

Two studies on the EndoBarrier were recently presented at the United European Gastroenterology Week. One described the effect of the device on hormones related to diabetes, while the other showed that a new device can be implanted once the initial 12-month implantation has been completed, extending the clinical benefits of the device.

“Over the past several years, we have successfully completed extensive clinical studies and achieved several regulatory approvals outside the US,” said Randle. “It has been extremely rewarding to see the benefits EndoBarrier has brought to people living with type 2 diabetes.”

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