We are pleased to announce that today the FDA approved the expanded use of the LAP-BAND® Adjustable Gastric Banding System. Please see the attached press release for your information.
The new indication statement for LAP-BAND® now reads as follows:
The LAP-BAND® System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions. It is indicated for use in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.
The LAP-BAND® System is now the first and only FDA-approved device for bariatric surgery in patients with a BMI of 30-35 and one or more obesity related comordid conditions.
This is EXCITING news for our customers and potential patients. Patients with a BMI 30-35 represent more than 26 million1 NEW patients who previously did not qualify for surgery. This addition more than doubles the potential patient population for LAP-BAND® surgery.
If you are contacted by the media concerning the new approval, please direct them to: