EnteroMedics has reported subgroup analysis data from EMPOWER trial of its pacemaker-like device, designed to target the multiple digestive functions under control of the vagus nerves and to affect the perception of hunger and fullness.
The device, Maestro system, delivers VBLOC vagal blocking therapy via two small electrodes that are laparoscopically implanted and placed in contact with the trunks of the vagus nerve just above the junction between the esophagus and the stomach.
The objective of the subgroup analysis was to determine if VBLOC therapy could improve blood pressure prior to significant weight loss in obese subjects with hypertension.
The analysis was performed in a subset of subjects who had = 9 hours therapy delivered per day to 12 months.
University of Virginia Health System endocrinology and metabolism division professor Robert Carey said the results of the subgroup analysis has demonstrated a clinically meaningful, non-pharmacologic, immediate and sustained reduction in blood pressure in obese subjects with hypertension.
"This effect suggests that VBLOC Therapy may offer the first, non-pharmacologic intervention for hypertension in obese subjects, a clinical outcome that, with available obesity surgical treatments, has never before been achieved," Carey added.
EnteroMedics president and chief executive officer Mark Knudson said the data adds to the company’s extensive clinical experience with VBLOC therapy and the Maestro system in obesity and its related co-morbidities of hypertension and diabetes.
"We have begun the process of amending our CE Mark certification to include these effects on hypertension and diabetes, adding to our obesity certification," Knudson added.