For years, Mike Magnant of Carver, Mass., struggled with his weight. He tried dieting many times, but after losing 25 pounds, he'd quickly gain it back. At 5 feet 6 inches tall, he weighed 291 pounds.
He had considered gastric bypass surgery, which reduces the amount of food a person can eat. But he resisted the idea because a friend had suffered debilitating side effects from the procedure. Then he heard on the radio about a clinical trial of a new device that is implanted near the stomach and sends signals to the brain that the person is not hungry. So he called to find out if he could enroll.
“I was tired, I was winded, I couldn't do any exercise or strenuous work, and my blood pressure was high,” he said. Then in his late 50s, he decided he had to try something different.
In December 2011, Magnant enrolled in a clinical trial at Tufts University in which he received a pacemaker-like device implanted subcutaneously just above the junction between the esophagus and stomach. The device, called the Maestro System and marketed by St. Paul, Minn.-based EnteroMedics, is designed to help obese patients with a body mass index of at least 40 by intermittently blocking the primary nerve that regulates the digestive system, reducing feelings of hunger. The device can be non-invasively programmed, and it can be adjusted, deactivated, reactivated or removed if desired.
Following the implant, Magnant lost 50 pounds on top of the 20 he had shed before the operation, and he's since maintained a weight of about 221 pounds.
In January, the Food and Drug Administration approved the Maestro System implant. It's the first new type of medical device approved by the FDA to treat obesity in more than a decade. Its approval in January is drawing interest from investors, physicians and patients who have seen little innovation in the obesity treatment market, which has the potential to reach 20 million obese Americans who are candidates for surgical interventions. The approval likely will mean more companies will try to bring new types of obesity devices to market, experts say.