Allergan (Irvine, CA) received FDA approval to expand the labeled use of their Lap-Band device to “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.”
The approval to expand the use of the LAP-BAND® Adjustable Gastric Banding System is based on a review of full 12-month data and available 24-month data from a prospective, single-arm, non-randomized, multi-center five year-study and the more than 17-year safety and effectiveness record of the LAP-BAND® System. Following approval, the patients in the trial will continue to be followed for a total of five years. In addition, there will be an analysis of the outcomes of patients with BMI of 30 to 40 recorded in the Bariatric Outcomes Longitudinal DatabaseSM (BOLDSM). Established in 2007 by the Surgical Review Corporation, BOLD is now the world’s largest and most comprehensive repository of clinical bariatric surgery patient information. The database currently contains more than 300,000 patients and 12,000 new patients are added monthly. The BOLD analysis will consist of examining the explant rates, adverse events, weight loss, and changes in the status of obesity related comorbid conditions observed in LAP-BAND® System patients over the course of 10 years.
Product page: LAP-BAND…
Press release: FDA Approves Expanded Use of LAP-BAND® Adjustable Gastric Banding System for Obese Adults…
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