Minnesota Firm’s Weight-Loss Device First in Seven Years to Receive FDA Approval

MINNEAPOLIS (Minneapolis Star Tribune/TNS) -

A Minnesota company has received approval to sell a first-of-its-kind implantable device that uses electric stimulation to curb obesity by fooling a patient’s brain into believing the stomach is full.

The Food and Drug Administration on Wednesday approved EnteroMedics’ Maestro System — the first obesity-fighting device to be approved for U.S. sales in more than seven years. The rechargeable device is considered a “reversible” weight-loss therapy, because it doesn’t surgically alter the digestive system or create barriers to food absorption.

“Obesity and its related medical conditions are major public-health problems,” said Dr. William Maisel, chief scientist in the FDA’s medical-device center, in the announcement of the approval. “Medical devices can help physicians and patients to develop comprehensive obesity-treatment plans.”

The device is only approved for patients 18 and older who, in the past five years, haven’t been able to lose weight in a supervised weight-management program. Eligible patients must have a body mass index of 35 to 45 and at least one other related health condition like Type 2 diabetes, high blood pressure or high cholesterol.

EnteroMedics’ stock on the Nasdaq surged on the news. The shares closed up 18.6 percent, or 22 cents, to $1.40.

The St. Paul-based development-stage company, whose only product is the Maestro System, listed a $24.7 million net operating loss on $25 million in cash and assets in the year ended last March.

The Maestro works by sending electric stimulation from a pacemaker-like device to the body’s vagus nerve, which regulates the digestive system.

“By blocking signals along the nerves that connect the brain and stomach, (the therapy) reduces feelings of hunger and promotes earlier feelings of fullness, which can help people with obesity reduce the number of calories consumed and promote safe, healthy and durable weight loss,” said Dr. Scott Shikora, chief consulting medical officer at EnteroMedics, in a news release.