EnteroMedics receives approval for Gastric Vest System clinical study in Spain
EnteroMedics announced that the company has received approval from the Ministry of Health, Social Services, and Equality 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 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. Enrollment is expected to begin by early 2018.