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Home > About the LAP-BAND AP® System > A Band-to-Band Comparison

About the LAP-BAND AP® System

A Band-to-Band Comparison

Feature

The LAP-BAND AP® System

The Realize™ Band-C
History of Use in the U.S.
  • LAP-BAND® System FDA approved in 2001 and LAP-BAND AP® System approved in 2006 — in market six years longer than Realize™ Band in the U.S
  • The first and only FDA-approved (2011) device for bariatric surgery in patients with a Body Mass Index (BMI) of ≥ 30 kg/m2 with one or more obesity related comorbid conditions
  • With three generations of improvements to the LAP-BAND® System, Allergan has the expertise in implantable silicone devices to bring ongoing innovation and advanced technology
  • Ten years of experience in the U.S.
  • FDA approved in 2007









  • Two generations of improvements





  • Four years of experience in the U.S.
Band Features
  • 360o OMNIFORM® technology — soft, precurved individual sections minimize potential for crease-fold failure and leaks
  • Concentric shape at any inflation volume
  • Wide balloon with minimal lateral exposure — limits the risk of puncture during surgery
  • Thickest shell available — reduces the risk of balloon fatigue and failure (.043 inch average shell thickness).
  • Balloon is 1 long silicone tube that creases at placement


  • Triangular shape when inflated

  • Wide balloon with broad lateral exposure

  • Thin shell (.022 inch average shell thickness)
Flexibility
  • The only system available in 2 sizes to address every patient’s needs*



  • Access Port available in 2 sizes — to meet the needs of different patients
  • Port placement with either manual sutures or mesh
  • Band-C available in only 1 size‡




  • Only 1 port — can be difficult to palpate in heavier patients
  • Port placement with mechanical applier — manual suture if appropriate fixation cannot be accomplished by integrated fastening hooks
Results

New LAP-BAND AP® Experience (APEX) Study:*†1

  • Significant excess weight loss (EWL) with the LAP-BAND AP® System
    • 47.5% EWL at 12 months (n=276)
    • 53.3% EWL at 24 months (n=100)

For those with a Body Mass Index (BMI) between 30 and 40, a new study (N=149) shows that the LAP-BAND® System provides significant results.2,3

In the first 12 months (N=143):

  • The mean Excess Weight Loss (EWL) was 64.5%2
  • The mean reduction in Body Mass Index (BMI) was 6.5 points2
  • The mean reduction in waist circumference (in inches) for men was 6.1 inches; women 5.9 inches3
  • Weight loss results were maintained at year 23

*The LAP-BAND® System was approved in the United States on the basis of nonrandomized, single-arm study (N=299). Significant improvement in percent of excess weight loss vs baseline was achieved at 12 months (34.5%), 24 months (37.8%), and 36 months (36.2%).

† Data based on interim analysis of ongoing LAP-BAND AP® trial.

*The LAP-BAND AP® System family of products consists of 5 bands. LAP-BAND® Access Port I and II are not shown at actual size.

‡The Realize™ family of products consists of 2 bands. Realize™ Band-C port is not shown at actual size.

  1. Data on file, Allergan, Inc. November, 2010.
  2. Directions For Use (DFU). LAP-BAND AP® Adjustable Gastric Banding System with OMNIFORM® Design. Allergan, Inc. Irvine, CA. 02/11. The LAP-BAND® System was approved in the United States on the basis of a nonrandomized, single-arm study (N=299). Significant improvement in percent of excess weight loss vs. baseline was achieved at 12 months (34.5%), 24 months (37.8%), and 36 months (36.2%).
  3. LAP-BAND® Adjustable Gastric Banding System P000008/S017. Gastroenterology and Urology Devices Panel, Food and Drug Administration. Accessed March 25, 2011 at: http://www.fda.gov/downloads/AdvisoryCommittees /CommitteesMeetingMaterials
    /MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM237422.ppt    .
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