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MetaCure’s Tantalus

This article was originally published in The Gray Sheet

Executive Summary

Enrollment in a recently begun 300-patient U.S. study of the gastric stimulator implant for treatment of type 2 diabetes in overweight patients is slated to conclude in June 2009, the firm says. The randomized trial will evaluate the device's impact on blood glucose levels, weight loss and blood pressure, and will be used to support an eventual PMA submission, MetaCure notes. The CE-marked device includes a pulse generator and leads that are implanted via a minimally invasive procedure; it senses the electrical activity of the stomach and automatically applies electrical stimulation to the organ at meal times
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