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Neurostim Companies Defend Their Role in Obesity

In early October, EnteroMedics announced the preliminary results of its pivotaltrial on its vagal nerve blocking approach to obesity. The verdict: the study did not meet primary or secondary end points. This was the second neuromodulation company working in obesity (Medtronic was the first) to experience a disappointment in pivotal clinical trials after early results looked so good. Several neurostimulation companies are still targeting obesity. Should their investors be worried? Is this troubling news for the field of neuromodulation at large? Not surprisingly, executives from two neurostimulation companies--IntraPace and Leptos Biomedical--answer the questions simply: no and no.

The promise of neuromodulation in obesity—and in medicine in general—is ease of use. The devices don't alter a patient's anatomy, are often easily implanted in an outpatient procedure, are non-invasively reprogrammable, and by every measure, safe. But comfort and safety aren't enough. Companies need to show that these devices work, and that's proven to be an elusive goal. (See "Appetite for Obesity Devices Stays Strong," START-UP, November 2009 [A#2009900259.)

In early October, EnteroMedics Inc. announced the preliminary results of its vagal nerve blocking approach to obesity. Almost 300 patients with a BMI in the range of 35-45 were...

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