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EndoBarrier

GI Dynamics resumes EU EndoBarrier shipments

The company will clarify its indications for use to reflect that its obesity indication includes a restriction to patients with a BMI≥30

GI Dynamics has announced that its Notified Body in the European Union, an organisation that has been accredited by Member States to assess whether a product meets the requirements of the EU Medical Device Directive 93/42/EEC, has cleared the company to resume commercial product shipments of the EndoBarrier. The decision by the Notified Body will permit the company to resume commercial activities in all jurisdictions where it was previously selling EndoBarrier.

As a result of a review of the company’s historical Clinical Evidence for the EndoBarrier product, the company will clarify its indications for use to reflect that its obesity indication includes a restriction to patients with a BMI≥30. The company’s revised indications for use will now read: The GI Dynamics’ EndoBarrier Gastrointestinal Liner System is used for the treatment of obese type 2 diabetes with BMI ≥30 kg/m2, or obese patients with BMI ≥ 30 kg/m2 with ≥ 1 co-morbidities, or obese patients with BMI >35 kg/m2’. Based on these indications for use, and the Clinical Evidence used for the review, the Risk: Benefit profile of EndoBarrier Therapy is considered appropriate.

“We are pleased to have resolved the outstanding questions surrounding EndoBarrier Therapy and want to thank all stakeholders for their patience during this recent period of review and remediation of matters related to our vigilance systems,” said Michael Dale, the Company’s president and CEO. “I truly believe that, as a result of this experience, we are a stronger organization. On behalf of all GI Dynamics employees; I want to assure our patients, physicians and regulatory authorities around the world of our absolute commitment to continuous quality improvement in all that we do”

The company temporarily suspended commercial product shipments labelled with a CE Mark affecting all countries where it is currently selling EndoBarrier, pending a review of its vigilance and reporting systems, in October 2014

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