Vanderbilt University Medical Center is one of the hospitals across the nation now enrolling patients in a clinical trial to evaluate the effectiveness of the Tantalus II gastric pacemaker, a device from Bermuda-based Metacure. The study will evaluate the Tantalus II for treatment of Type 2 diabetes, via laparoscopic implantation of this electric stimulator of the stomach, in patients who are obese by reducing their blood sugar levels and weight. The device is approved (CE Mark) for sale in the European Union.
The TANTALUS works by applying programmed electrical stimulation to the stomach during food intake. The system monitors the patient’s food intake by sensing gastric activity and automatically adapting a treatment schedule based on eating habits. As a result there is minimal patient action required for applying the stimulation intended to treat type 2 diabetes as well as other related conditions such as overweight and hypertension…
The system includes a rechargeable ‘pacemaker-like’ implantable pulse generator (IPG) with an external, portable charger; bipolar leads and external control and monitoring components for the patient and physician. The IPG is implanted under the skin and delivers electrical stimulation to the muscle through leads implanted in the sero-muscular layer of the stomach.
The TANTALUS System is based on new technology called Gastric Contractility Modulation (GCM) that is designed to sense naturally occurring electrical activity of the stomach in real-time and automatically apply electrical stimulation treatment during meal times. The device data can be non-invasively read by the physician for further tailoring of the treatment parameters to the patient. The result is enhanced gastric activity without a change in the rate of electrical activity (no pacing). The application of this unique stimulation during initial stages of meals is designed to provoke an early response of the gut typical of a full meal.
The system includes a rechargeable ‘pacemaker-like’ implantable pulse generator (IPG) with an external, portable charger; bipolar leads and external control and monitoring components for the patient and physician. The IPG is implanted under the skin and delivers electrical stimulation to the muscle through leads implanted in the sero-muscular layer of the stomach.Here’s a brochure being distributed in Vanderbilt to potential participants in the study:
Metacure homepage…
The Vanderbilt Center for Surgical Weight Loss study page: Surgical Treatment for Type II Diabetes…
The brochure (.pdf)…