LAP-BAND AP Early Experience Trial (APEX)

The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients.

The primary objective of this study was to collect additional information about the safety and effectiveness of the LAP-BAND AP System in a real-life clinical setting. Effectiveness was assessed through the collection of weight loss data, as well as other secondary effectiveness measurements. Safety was assessed by the incidence and severity of adverse events (AEs) related to treatment.

Inclusion Criteria:

• Patient is scheduled to receive the LAP-BAND AP System
• Willingness to follow protocol requirements, including: the Informed Consent Form (ICF), Health Insurance Portability and Accountability Act (HIPAA) forms, follow-up schedule, completion of patient questionnaires.

Exclusion Criteria:

• Per the LAP-BAND AP System Directions For Use (DFU)