EnteroMedics has secured approval from the Ministry of Health, Social Services, and Equality (MHSSE) in Spain via the Agency of Medicines and Medical Devices, and the CEIC Ethics Committee to start a clinical trial for the Gastric Vest System in Spain.
"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."
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.
About the Gastric Vest System
The Gastric Vest System (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.