FDA uses patient preference data to approve obesity device

FDA considered agency-sponsored survey data on patients' risk tolerance and preferences of obesity devices prior to approving a PMA from EnteroMedics Inc. (NASDAQ:ETRM) for its implantable Maestro Rechargeable (RC) System to treat obesity in adults. EnteroMedics plans to sell the electrical pulse-based vagal-blocking therapy as VBLOC Therapy.

VBLOC Therapy is approved to treat adults with a BMI of at least 40-45 kg/m2, or a BMI of at least 35-39.9 kg/m2 with an obesity-related condition, and who have not been able to lose weight in a supervised weight management program within the past five years. ...