About the LAP-BAND AP® System

The LAP-BAND AP® System is placed laparoscopically, and is intended for use by surgeons with advanced laparoscopic skills. Learn more about LAP-BAND AP® System certification here.

 

Rollover the highlighted areas to learn more about the features of the LAP-BAND AP® System.


Features and Benefits of the LAP-BAND AP® System:

Proven Performance

  • Effectiveness
    • comparable weight loss to gastric bypass at 3 years and beyond1
  • New LAP-BAND AP® Experience (APEX) Study*† 2
    Study Design
    • Multicenter (44 sites), prospective, open-label, 5-year evaluation of 500 severely obese patients undergoing LAP-BAND AP® surgery
    • Interim analysis evaluated patients (n=303) who have completed 24 weeks of follow-up
      • Includes subset of patients (n=139 ) who have completed 48 weeks of follow-up
    Study Results
    • 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)

*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.

New FDA-Approval

The LAP-BAND® System is the first and only FDA-approved device for bariatric surgery in patients with a BMI of ≥ 30 kg/m2 with one or more obesity related comorbid conditions.

  • A new study (N=149) shows that the LAP-BAND® System provides significant results.3,4
    In the first 12 months (N=143):
    • The mean Excess Weight Loss (EWL) was 64.5%3
    • The mean reduction in Body Mass Index (BMI) was 6.5 points3
    • The mean reduction in waist circumference (in inches) for men was -6.1 inches; women -5.9 inches4
  • Weight loss results were maintained at year 24

Established Safety

  • Various studies of the LAP-BAND® System have demonstrated:
    • Up to 61% fewer total complications than gastric bypass5
    • As low as one-tenth the short-term mortality rate of gastric bypass6
    • As low as 10% of the major complications observed with gastric bypass5

Advanced Technology


360o OMNIFORM® technology

soft, precurved individual sections designed to minimize the potential for crease-fold-failure and associated leaks

Wide balloon with minimal lateral exposure

  • Provides broad area of stomach contact
  • Limits the risk of puncture during surgery

Thickest shell available

Reduces the risk of balloon fatigue and failure
  • .043 inch average shell thickness

Customized restriction for optimal fit

The only system available in 2 sizes to address every patient's needs

Access Port available in 2 sizes (standard and low profile)§

  • Better patient adaptability

The LAP-BAND® System family of products consists of 5 bands. The Realize™ family of products consists of 2 bands. Realize™ Band-C port is not shown at actual size.
§ LAP-BAND® Access Port I and Port II are not shown at actual size.

References:

  1. O'Brien PE, McPhail T, Chaston TB, et al. Systemiatic review of medium-term weight loss after bariatric operations. Obes Surg. 2006;16:1032-1040.
  2. Data on file, Allergan, Inc. November, 2010.
  3. 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%).
  4. 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
    .
  5. Parikh MS, Laker S, Weiner M, Hajiseyedjavadi O, Ren CJ. Objective comparison of complications resulting from laparoscopic bariatric procedures. J Am Coll Surg 2006;202:252-261
  6. O'Brien PE, Dixon JB. Lap-Band: Outcomes and Results. J Laparoendosc Adv Surg Tech 2003;13:265-270.
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