FDA approves Allergan Lap-Band System expanded use

The US Food and Drug Administration (FDA) has approved the expanded use of Allergan's Lap-Band System, a device for the treatment of obesity.

With the new approval, the Lap-Band System procedure is now indicated for obese adults with a Body Mass Index (BMI) of 30-40 with at least one obesity related comorbid condition, who have failed more conservative weight reduction alternatives.

The approval to expand the use of Lap-Band was based on a review of data from prospective, single-arm, non-randomised, multi-centre five year-study as well as 17-year safety and effectiveness data.

The Lap-Band System was originally approved by the FDA in 2001 for obese adults with a BMI of 35 with at least one severe comorbid condition or a BMI of 40, or those who are at least 100 pounds or more overweight.