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Product expansion

FDA expands Lap-Band approval

Approval based on a review of full 12-month data and available 24-month data

The FDA has approved the expanded use of the Lap-Band System (Allergan) gastric band for adults with obesity who have failed more conservative weight reduction alternatives like diet and exercise and pharmacotherapy and have a BMI of 30-40, and have 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-randomised, multi-centre 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 Database (Bold). 

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 every month. 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 ten years. 

LBMI-001 clinical study 

The Lap-Band System study, initiated by Allergan and conducted under an FDA-approved Investigational Device Exemption, was conducted to determine the safety and effectiveness of the Lap-Band System as a treatment for obesity in adult patients with a BMI of ≥30 and <40, with and without comorbid conditions. The study was initiated in 2007, and included 149 patients, who had a mean excess weight of 62.8lbs, had been obese on average for 17 years and had undergone the Lap-Band System procedure. 

The criterion for success was at least 40% of patients achieving clinically meaningful weight loss at the 12-month period, where clinically meaningful weight loss was defined as at least 30% excess weight loss. Results from the 12-month dataset demonstrate clinically significant weight loss in this patient group with a low risk of serious complications. Specifically, 83.9% of the patients lost at least 30% of their excess weight at the one-year period, more than twice the percentage required for success. More than 65% of the patients in the trial were no longer obese after one year. Weight loss was maintained in the second year of the study. 

The secondary endpoints for the trial were improvement in obesity related comorbid conditions of dyslipidemia, Type 2 diabetes, and hypertension and improvement in quality of life. 85% of subjects in the trial had at least one comorbid condition. In terms of improvement in comorbid conditions of dyslipidemia, type 2 diabetes, and hypertension, 22-33% of patients with those conditions saw their conditions resolved after one year. In addition, approximately 60% of patients, who had a comorbidity at baseline, had improvement of at least one comorbid condition by month 12. Also, there was a statistically significant improvement in quality of life at months six and 12. 

During the 12-month study period, the types of adverse events reported by patients were as expected for the surgical procedure, such as vomiting, dysphagia, and gastroesophageal reflux disease, the investigators reported. Most adverse events were mild to moderate in severity and resolved in less than four weeks. 

The Lap-Band System was originally approved by the FDA in 2001 for use in severely obese adults, individuals with a BMI of 35 with at least one severe comorbid condition or a BMI of 40, or those who are at least 100lbs or more overweight. The Lap-Band System has been approved internationally since 1993. 
The Lap-Band System is not recommended for non-adult patients, patients with conditions that may make them poor surgical candidates or increase the risk of poor results (e.g., inflammatory or cardiopulmonary diseases, GI conditions, symptoms or family history of autoimmune disease, cirrhosis), those who are unwilling or unable to comply with the required dietary restrictions, those who have alcohol or drug addictions or those who currently are or may be pregnant. 

"Given the proven and significant health ramifications of obesity, we are pleased with the FDA's decision to expand the use of the Lap-Band System," said Dr Frederick Beddingfield, Allergan's Vice President of Clinical Research and Development. "Although this label expansion represents a significant advancement in obesity treatment, the Lap-Band System is not intended for everyone. The Lap-Band System does represent a potential treatment option for those patients with obesity and a related health condition, who have failed more conservative weight-loss therapies, such as diet and exercise and pharmacotherapy, and under consultation with their physician, have determined that weight-loss surgery is the next best treatment option." 

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