An FDA advisory committee voted 8 to 2 that Allergan's Lap-Band device is safe enough to use in patients with a BMI as low as 30.
The stomach-shrinking device is currently approved for weight loss in people who are at least 100 pounds overweight or have a body mass index (BMI) of at least 40, or a BMI of at least 35 with other comorbidities such as heart disease.
Allergan is looking for approval to lower those BMI cutoffs to 35 and 30 respectively.
If the FDA follows the advice of its advisory committee the Lap-Band could be an option for another 27 million Americans.
The Lap-Band is an adjustable silicon band that is implanted through tiny incisions around the upper stomach. It works by reducing stomach capacity and thus the amount of food the stomach can hold. Its use involves a less invasive procedure than gastric bypass or stomach stapling, but it is also less effective, FDA reviewers noted in briefing documents released in advance of Friday's meeting.
The FDA's Gastroenterology and Urology Devices Panel spent Friday discussing Allergan's single-arm study of 143 patients with the lower BMI criteria.
All 143 had significant reductions in weight and BMI after one year, with only 37% still meeting the criteria for obesity.
After one year, eight out of 10 Lap-Band recipients lost at least 30% of their excess weight, and 66% lost at least half.
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