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.

The Access Port is where your adjustments are made - easily accessible, comfortable and discreet. It is securely attached beneath your skin, in the best position for adjustments and comfort.

The LAP-BAND AP^® System silicone tubing and band are stable and well-tolerated by your body. It's soft yet durable, and will be placed securely yet comfortably for you.

The OMNI FORM^™ technology offers you a larger inflation range (360^o) through individual 'pillows' around the inside. As saline is added or taken out, the pillows 'adjust' your LAP-BAND^®.

Your surgeon will make adjustments by adding or removing saline from these little 'pillows' in the LAP-BAND^®, through the Access Port and tubing. It's easy, quick and with minimal pain.

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

360^o 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.