EnteroMedics : FDA Oks VBLOC Vagal Blocking Therapy To Treat Obesity; Stock Up

(RTTNews) - EnteroMedics Inc. (ETRM) announced that the U.S. Food and Drug Administration (FDA) has approved VBLOC vagal blocking therapy, delivered via the Maestro System, for the treatment of adult patients with obesity who have a Body Mass Index (BMI) of at least 40 to 45 kg/m2, or a BMI of at least 35 to 39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels, and who have tried to lose weight in a supervised weight management program within the past five years.

The Maestro Rechargeable System, the first FDA-approved obesity device since 2007, is approved to treat patients aged 18 and older who have not been able to lose weight with a weight loss program, and who have a body mass index of 35 to 45 with at least one other obesity-related condition, such as type 2 diabetes.

EnteroMedics anticipates that the device will be available, on a limited basis, at select Bariatric Centers of Excellence in the U.S. this year. The Maestro System has received CE Mark and is listed on the Australian Register of Therapeutic Goods.

The Maestro System is a pacemaker-like device that is implanted, usually in an outpatient procedure, to control both hunger and fullness by intermittently blocking the primary nerve which regulates the digestive system, the vagus nerve. VBLOC Therapy does not surgically alter or restrict the digestive system, does not create barriers to prevent absorption of nutrients and is completely reversible, allowing patients to lose weight without lifestyle compromises.

ETRM closed Wednesday's regular trading at $1.40, up $0.22 or 18.64%. In after-hours, the share further gained $0.06 or 4.29%.