EndoBarrier® Back on EU Market, with Revised IFU

Back in early October we reported that GI Dynamics, Inc. had seen its European selling activities suspended by its Notified Body for reasons given as deficiencies in its Quality System. It seems they’ve put things right, as a new announcement tells us the company has been cleared to resume commercial shipments of its EndBarrier® product.

Background

EndoBarrier® is the first endoscopically-delivered device therapy approved for the treatment of type 2 diabetes and/or obesity. It is approved in multiple countries outside the U.S. and was commercially available in Europe until the October announcement that GI Dynamics had had its activities suspended in the territory pending a review of its vigilance and reporting systems.

However it seems that what looked to the casual observer like a paper exercise, may have had slightly broader implications for the product itself, or at least its indications. The company has needed to clarify its indications for use to reflect that its obesity indication includes a restriction to patients with a body mass index (BMI) ≥ 30 kg/m2. The 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, GI Dynamics’ statement says the Risk:Benefit profile of EndoBarrier Therapy is considered appropriate.

As yet the share price doesn’t appear to suggest any huge sighs of relief among investors, being virtually unchanged from the $0.30 level it’s languished at since the October bombshell that coincided with a weakened sales position.

Company comments

Michael Dale, the Company’s President and Chief Executive Officer, said, “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. 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.”

Source: GI Dynamics, Inc.

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