The FDA Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee recommended, with an 8-2 vote, that the FDA extend the currently approved use of the Lap-Band System, in people who have a body mass index (BMI) of at least 35 or patients with a BMI greater than or equal to 30 who also has at least one comorbid condition.
The panel’s recommendation is non-binding, but the FDA typically acts on its suggestions.
The LAP-BAND System was originally approved by the FDA in 2001; it received international approval in 1993. Over the past 17 years, more than 600,000 procedures have been performed, according to the news release.
Read the Allergan news release about the lap-band system.
Read more about bariatrics:
– 3 Big Opportunities for ASC Growth Now
– Most Profitable Specialties for ASCs With Brian Mathis of Surgical Care Affiliates
