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Gastric Vest study

EnteroMedics gains approval for Gastric Vest study in Spain

CE Mark study for the Gastric Vest to include a total of between 50-100 patients at up to four sites within the European Union

EnteroMedics has received approval from the Ministry of Health, Social Services, and Equality (MHSSE) in Spain through the Agency of Medicines and Medical Devices, and the CEIC Ethics Committee to initiate a clinical trial for the Gastric Vest System (GVS) in Spain.

EnteroMedics expects the safety and performance CE Mark study for the Gastric Vest to include a total of between 50-100 patients at up to four sites within the European Union. This approval by the MHSSE in Spain represents the first country approval for the Gastric Vest CE Mark trial. 

The clinical trial in Spain will be conducted under the supervision of Principal Investigator, Dr Jordi Pujol Gebelli, and Co-Investigator, Dr Amador Garcia Ruiz de Gordejuela at Hospital Universitari de Bellvitge, in Barcelona, Spain. Enrolment is expected to begin by early 2018.

"We are thrilled to have reached this significant clinical milestone, which supports our plans for CE Mark approval and takes us one step closer to bringing our Gastric Vest product to market," said Dan Gladney, EnteroMedics President, Chief Executive Officer, and Chairman of the Board. "We believe that the Gastric Vest, which is designed to allow rapid excess weight loss over a short period of time through a minimally invasive, non-anatomy-changing procedure, will offer a novel solution for the obesity continuum of care."

The GVS is an investigational, minimally invasive, laparoscopically implanted medical device being studied for weight loss in obese and morbidly obese patients. The device wraps around the stomach, emulating the effect of conventional weight-loss surgery, and enables gastric volume reduction without permanently changing patient anatomy. In a pilot study conducted outside the US, at 12 months, Vest patients demonstrated a mean percent excess weight loss (%EWL) of 85%, an average drop in HbA1c (Haemoglobin A1c) of 2.1 points, and an average waist circumference reduction of 38cms.

EnteroMedics recently acquired the Gastric Vest System through its acquisition of BarioSurg in May 2017.

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