Post Implantation/Post Market Evaluation of the Swedish Adjustable Gastric Band

NCT00543140 (CI-06-0001) is the 2 year Safety and QOL subject follow-up study to NCT00166205 (CI-02-0006), completed on November 10, 2008. As a condition of approval, the FDA required additional subjects with long-term safety data. These subjects enrolled under protocol CI-07-0006 (NCT00813462)-5 Year Post-Approval Study With the REALIZE (TM) Adjustable Gastric Band. Protocol CI-06-0001 was amended to combine these study subjects with study subjects from CI-07-0006. NCT00543140 (CI-06-0001) will not be completed (analysis of results) until the additional subjects in NCT00813462 (CI-07-0006) complete this study since the original intent was to pool the data together from the above two studies to obtain the appropriate sample size for estimation of the re-operation rate at 4 and 5 years post implantation.

CI-06-0001 Inclusion Criteria:

Subjects eligible to participate in this study must fulfill all of the following criteria:

• Able to comprehend, follow and give signed informed consent;
• Consented to, and participated in EES Protocol CI-02-0006 titled "A Single-Arm, Multi-Center Study of the Safety and Effectiveness of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity";
• Currently have an SAGB implant in place;
• Able to commit to long-term follow-up; up to 5 years after SAGB implantation, including band adjustment visits; and
• Living within the contiguous U.S.

CI-07-0006 Inclusion Criteria:

Subjects eligible to participate in this study must fulfill all of the following criteria:

• Able to comprehend, follow and give informed consent;
• 18 to 60 years of age (inclusive);
• Body Mass Index (BMI) of > 40 kg/m2 and £ 55 kg/m2, or BMI ³ 35 kg/m2 and < 40 kg/m2 with one or more co-morbid conditions.
• Candidate for surgical weight loss intervention in accordance with the Instructions For Use (i.e., meets acceptable health criteria for major surgery).

CI-06-0001 Exclusion Criteria:

Subjects with the following are not eligible to participate in this clinical trial and must not be enrolled in this study:

a. Consented to, and participated in EES Protocol CI-02-0006 titled "A aSingle-Arm, Multi-Center Study of the Safety and Effectiveness of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity"; and have had the SAGB explanted.

CI-07-0006 Exclusion Criteria:

• Women who are currently pregnant.
• Previous malabsorptive or restrictive procedures performed for the treatment of morbid obesity.
• Documented history of drug and/or alcohol abuse within 2 years of the Screening Visit (1a).
• Presence of any of the following medical conditions;

• Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration or duodenal ulceration, or specific inflammation such as Crohn's disease;
• Severe cardiopulmonary disease or other serious organic disease;
• Upper gastrointestinal bleeding conditions such as esophageal or gastric varices or intestinal telangiectases;
• Portal hypertension;
• Anomalies of the gastrointestinal tract such as atresia or stenosis;
• Cirrhosis of the liver;
• Chronic pancreatitis;
• Patients on chronic, long-term steroid treatment or steroids within 15 days of surgery;
• Unable or unwilling to comply with dietary restrictions required by this procedure;
• Known allergy to materials contained within the band or its injection port (silicone elastomer containing 10% BaSO4, polyetheretherketone (PEEK), and cobalt chromium)
• Presence of terminal illness with life expectancy of £ 5 years.
• Inability to refrain from use of anticoagulants or aspirin within 15 days prior to surgery.
• Acute or chronic infection (localized or systemic).
• Participation in another clinical trial within 8 weeks of the Screening Visit (1a) and for the duration of this trial.
• Any medical condition or finding for which the Investigator utilizes their medical discretion to determine the subject should be excluded due to inability to understand or follow study procedures.