EnteroMedics has presented hypertension data from its trial of VBLOC vagal blocking therapy for the treatment of obesity, delivered via the Maestro system.
Using the company’s proprietary technology, the pacemaker-like device delivers VBLOC 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.
Subgroup analysis was conducted to determine if VBLOC therapy can 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, according to the company.
University of Virginia Health System endocrinology and metabolism division professor Dr Robert Carey said the results of the substudy analysis have 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 said.
EnteroMedics president and chief executive officer Dr 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 said.
The randomised, double-blind, controlled pivotal EMPOWER trial was designed to assess the safety and efficacy of the Maestro system using VBLOC vagal blocking therapy in only treating obese subjects.