Enteromedics wins approval for Gastric Vest study in Spain

EnteroMedics (NSDQ:ETRM) said today it won approval from Spain’s Ministry of Health, Social Services and Equality to initiate a clinical trial of its Gastric Vest system in Spain.

The Gastric Vest system is a minimally invasive, laparoscopically implanted device designed to aid obese and morbidly obese patients lose weight. The device wraps around the stomach to emulate the effective of conventional weight-loss surgery, and allows for gastric volume reduction without permanent anatomical changes, EnteroMedics said.

The St. Paul, Minn.-based company is looking to enroll between 50-100 patients at 4 sites within the European Union, hoping to use the study to support CE Mark approval in the region.

“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. 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,” prez & CEO Dan Gladney said in a prepared statement.

Earlier this month, EnteroMedics said it inked a collaborative deal with Galvani Bioelectronics, a joint venture between GlaxoSmithKline (NYSE:GSK) and Alphabet‘s (NSDQ:GOOGL) Verily Life Sciences, through which Galvani will use a modified vBloc system for pre-clinical research.

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