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Lap-Band

Device type

Company

Released

Region: 
USA
Year: 
1993
Region: 
International
Year: 
2001
Year: 
2012
Year: 
2012

Description

The Lap-Band Adjustable Gastric Banding System is the first adjustable medical device approved by the U.S. Food and Drug Administration (FDA) in the United States for individualized weight loss for obese patients whose weight is affecting their health.

The Lap-Band System was originally approved by the FDA in 2001 for use in weight reduction for severely obese adults with a BMI of 40 or more, or for adults with a BMI of at least 35 plus at least one severe obesity-related health condition, such as Type 2 diabetes, hypertension and asthma. In February 2011, the FDA approved the expanded use of Lap-Band for adults with obesity who have failed more conservative weight reduction alternatives, such as diet and exercise and pharmacotherapy, and have a Body Mass Index (BMI) of 30-40 and at least one obesity related comorbid condition. In addition, the Lap-Band System has been approved internationally since 1993. The Lap-Band System is now the first and only FDA-approved device for weight-loss surgery in patients with a BMI of 30-35.