NewsNational

Actions

Weight loss 'pacemaker' gets FDA approval, first obesity device since 2007

CORP-Digital-Default-Image-1280x720-WPTV.png
Posted at 4:11 PM, Jan 22, 2015
and last updated 2015-01-26 10:21:16-05

To cure an irregular heartbeat, many Americans wear a pacemaker.

But what about for an irregular appetite?

The FDA approved the first pacemaker-like device to treat obesity on Jan. 14. It is the first device to treat obesity approved since 2007, the agency said. The last approved devices were gastric bands.

The VBLOC or Maestro system is surgically-implanted into the abdomen. Like a pacemaker, its sends electrical impulses through wires. But instead of going into the heart, VBLOC targets a nerve near the stomach that regulates appetite.

That nerve, called the abdominal vagus nerve, carries signals that tell the brain when the stomach is empty or full. VBLOC blocks those signals. The FDA said it's not quite sure why that results in weight loss.

Device manufacturer EnteroMedics, based in St. Paul, Minnesota, said VBLOC is an “entirely new approach” to treating obesity.

“By blocking signals along the nerves that connect the brain and stomach, VBLOC reduces feelings of hunger and promotes earlier feelings of fullness,” said EnteroMedics’ Chief Consulting Medical Officer Scott Shikora in a statement.

 

More than one-third of American adults are obese, according to the Centers For Disease Control and Prevention.

“Obesity and its related medical conditions are major public health problems,” said William Maisel, chief scientist in the FDA’s Center for Devices and Radiological Health in a statement. “Medical devices can help physicians and patients to develop comprehensive obesity treatment plans.”

The VBLOC is designed for people with a body mass index of 35 to 45 (severely obese) who also have another condition caused by their obesity, like diabetes or high blood pressure.

A clinical study compared two sets of patients who had a Maestro implanted, but the device was only activated for some of them. One year later, the group with the active device lost 8.5 percent more weight compared to the control group.

However, the study did not quite reach its goal of losing 10 percent more excess weight than the control group.

An FDA survey showed that patients are willing to accept the risks of surgery for the amount of potential weight loss.

The manufacturer, EnteroMedics, must now conduct a 5-year follow-up study.

Gavin Stern is a national digital producer for the Scripps National Desk.