BACKGROUND: A new therapy (VBLOC) that intermittently blocks both vagi near the esophagogastric junction using high-frequency electrical algorithms has been reported to lower excess weight 14.2 (+/-) 2.2% in obese subjects as part of an earlier 6 month feasibility trial. The therapy is delivered by laparoscopically implanted electrodes. The proposed mechanisms for weight loss are down-regulation of gastric accommodation, contractions and emptying, as well as decreased pancreatic exocrine secretion and nutrient assimilation.
AIM: To evaluate the safety and efficacy of VBLOC on excess weight loss (EWL) using a second generation system in an ongoing open-label prospective clinical study.
METHODS: Study subjects were implanted with the vagal blocking system at three participating sites. Two weeks later, vagal blocking was initiated. Subjects have been followed out to 6 months, including visits for body weight, physical examination, clinical chemistries and adverse events (AEs).
RESULTS: Twenty-five subjects (mean BMI: 39.6 (+/-) 0.8) were implanted. EWL at 4, 12 and 26 weeks following implant was 10.7 (+/-) 1.3% (p
Program Number: P023