Compliance with Therapeutics Goods Act (Australia)
GI Dynamics Appoints Chief Compliance Officer
GI Dynamics Releases Safety and Efficacy Data for EndoBarrier Therapy
The GI Dynamics’ EndoBarrier® Gastrointestinal Liner System is used for the treatment of obese type 2 diabetes with BMI ≥ 30 kg/m2, or obese patients with BMI ≥ 30 kg/m2 with ≥ 1 comorbidities, or obese patients with BMI >35 kg/m2.
The liner is indicated for maximum implant duration of 12 months.
EndoBarrier is not approved for sale in the U.S. and is limited by federal law to investigational use only in the United States.
CAUTION: INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (UNITED STATES) LAW TO INVESTIGATIONAL USE