EnteroMedics Gets Ok to Initiate Clinical Trial in Spain

EnteroMedics shares were higher 7% in pre-market trade after the company said Monday it has received approval from Spain’s Ministry of Health, Social Services, and Equality (MHSSE), through the Agency of Medicines and Medical Devices, and the CEIC Ethics Committee, to initiate a clinical trial for the Gastric Vest System in Spain.

EnteroMedics said 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. Enrollment is expected to begin by early 2018. The Gastric Vest System is an investigational, minimally invasive, laparoscopically implanted medical device being studied for weight loss in obese and morbidly obese patients.

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