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
– Developing a Bariatrics Program in an ASC
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.