Implanted Electrical Device Reduces Weight, Hemoglobin A1c in Type 2 Diabetic Patients

Posted Sep 08, 2008.By Miriam E. Tucker

ROME (EGMN) - Mean hemoglobin A

The Tantalus system, manufactured by MetaCure Ltd., comprises a pulse generator and bipolar leads that are implanted laparoscopically in the antrum and fundus of the stomach. When food intake occurs, the system delivers nonexcitatory electrical stimulation to the gastric wall, thereby increasing the amplitude of the contractions and allowing the vagal nerve to send a signal to the brain, triggering earlier satiety. Previous data suggested that the device could safely produce clinically significant weight loss and reduce blood pressure in morbidly obese individuals at 1 year (Obes. Surg. 2006;16:627-34).

Findings from the current European multicenter, open-label pilot study were reported on Sept. 8 by Dr. Bruno Guerci at the annual meeting of the European Society for the Study of Diabetes.

Nineteen obese patients with type 2 diabetes not adequately controlled with oral hypoglycemic agents were implanted laparoscopically with the Tantalus system. The group comprised 12 men and 7 women, with a mean age of 53 years, body mass index of 38.1 kg/m², and baseline hemoglobin A

Mean hemoglobin A

The correlation between changes in body weight and A

Tantalus received CE mark (Conformité Européenne) in Europe in 2006 with an indication for the treatment of both type 2 diabetes and obesity (defined as a body mass index of 30-50 kg/m²), and is currently used in several centers in Germany. Pending a relaunch of phase III trials in the United States in 2009, approval by the Food and Drug Administration is expected in 2013, a company spokesman said in an interview.