EnteroMedics (St. Paul, MN) has released results of a 38 patient study showing that the company’s Maestro implant helped patients lose a considerable amount of body weight. The system uses high frequency electrical pulses to block signals in the vagal nerve between the stomach and the brain. We had a post about the EnteroMedics neuromodulation therapy back in May 2007.
From the company press release:
The study includes 38 implanted subjects and is designed to evaluate the system’s safety and efficacy. Follow-up data show excess weight loss, or EWL, of 37.6% in 9 patients at 18 months of VBLOC Therapy, 28.1% in 17 patients at 12 months of therapy and 17.9% in 35 patients at six months of therapy. To date, no deaths or unanticipated adverse device events have been reported.
In addition, further subgroup analysis of the effect of VBLOC Therapy on two of the major co-morbidities frequently associated with obesity, type 2 diabetes and hypertension, showed the following: ten patients with diabetes, showed a statistically significant reduction of 1.1 percentage points (p=.002) from 8.2% at baseline to 7.1% at four weeks and fifteen patients with both systolic and diastolic hypertension, which was either untreated or controlled with drugs, showed statistically significant reductions of 13.9 mm Hg in systolic pressure and 10.7 mm Hg in diastolic pressure at four weeks. The improvements in blood pressure are maintained through six months.
In addition to the VBLOC-RF2 study, the Maestro System is being used in the Company’s pivotal EMPOWER clinical trial, a randomized, prospective, double-blind, placebo-controlled study being conducted in the United States and Australia under an Investigational Device Exemption (IDE) approved by the U.S. Food and Drug Administration. The trial was fully enrolled at 15 Centers of Excellence with 294 patients in September 2008. The study blind, which remains in place for 12 months after activation of therapy in the experiment arm, is expected to lift in the second half of this year.