Safety and Effectiveness Study of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity

Surgical treatment of morbidly obese patients is considered a reasonable option for
achieving weight loss when more conservative measures, such as diet and exercise have
failed. Not only can weight loss be achieved, but also reduction / resolution of a patient's
co-morbidities associated with excess weight. Adjustable gastric banding provides a less
invasive, reversible bariatric surgery option. The SAGB has been commercially available
outside the United States for this indication since 1996. Commercial availability has led to
extensive literature supporting the safety and effectiveness of the SAGB. Given the
available literature, a prospective, single arm, multicenter, study in a heterogeneous
population of morbidly obese subjects in the U.S. is being conducted.

Inclusion Criteria:

- Able to comprehend, follow and give signed informed consent;

- 18 to 60 years of age (inclusive);

- Five year history of morbid obesity;

- Body Mass Index (BMI) >40 kg/m2 and <55 kg/m2, or BMI >35 kg/m2 and <40 kg/m2 with
one or more significant medical conditions related to obesity (co-morbid conditions
of type 2 diabetes, hyperlipidemia, obstructive sleep apnea, hypertension, metabolic
syndrome, or osteoarthritis of the hip or knee) for which the subject is being
treated, and which are generally expected to be improved, reversed, or resolved by
weight loss.

- 100 lbs. overweight or 1.5 times ideal weight;

- Documented failure of conservative, non-surgical means of weight reduction within one
year prior to the Screening Visit, including failure of supervised diet, exercise and
or behavior modification programs, and pharmacologic therapy;

- Willing to commit to significant lifestyle changes that include diet, eating, and
exercise habits for the duration of the clinical trial;

- Able to commit to long-term follow-up, including band adjustment visits:

- Living within the contiguous U.S. and is within a 100 mile radius of the study
center;

- Absence of significant psychopathology that could limit the subject's ability to
understand the procedure, comply with medical, surgical, and/or behavioral
recommendations, as documented during screening assessment;

- Agrees to refrain from any type of reconstructive surgery that would affect body
weight such as abdominal lipoplasty or liposuction, mammoplasty, or removal of excess
skin for the follow-up period following SAGB placement; and

- Candidate for surgical weight loss intervention (i.e., meets accepted health criteria
for major surgery).

Exclusion Criteria:

- Women of childbearing potential who are not practicing an effective method of birth
control or who are pregnant or lactating;

- Previous malabsorptive or restrictive procedures performed for the treatment of
obesity;

- Documented history of drug and/or alcohol abuse within two years of the Screening
Visit;

- History of impaired mental status including, but not limited to active substance
abuse, a history of schizophrenia, borderline personality disorder, uncontrolled
depression, suicidal attempts within the past two years or current suicidal
tendencies or ideations;

- Presence of any of the following medical conditions;

- Inflammatory diseases of the gastrointestinal tract, including severe
intractable esophagitis, gastric ulceration, duodenal ulceration, or specific
inflammation such as Crohn's disease that have been active within the past 10
years;

- Congenital or acquired anomalies of the GI tract, including atresias or
stenosis,

- Severe cardiopulmonary disease or other serious organic disease that makes the
subject a high-risk surgical candidate;

- Uncontrolled hypertension;

- Portal Hypertension;

- Uncontrolled Diabetes Mellitus;

- Chronic or acute upper gastrointestinal bleeding conditions, e.g. gastric or
esophageal varices;

- Cirrhosis;

- Congenital or acquired intestinal telangiectasia;

- Esophageal or gastric disorders including severe preoperative reflux,
dysmotility, or Barrett's Esophagus;

- Presence of hiatal hernia;

- Prior surgery of the foregut including hiatal hernia repair or prior gastric
surgery;

- Chronic pancreatitis;

- Immunocompromised such as that resulting from chronic oral steroid use,
chemotherapeutic agents, or immune deficiency disorders;

- Conditions that, in the opinion of the investigator, may jeopardize the
subject's well-being and/or the soundness of this clinical study;

- History or presence of pre-existing autoimmune connective tissue disease, i.e.,
systemic lupus erythematosus or scleroderma;

- Presence of terminal illness with life expectancy <5 years;

- Use of prescription or over the counter weight reduction medications or supplements
within one month of the Screening Visit and for the duration of study participation;

- Acute or chronic infection (localized or systemic);

- Known or suspected allergy to silicone or other materials contained in the Swedish
Adjustable Gastric Band;

- History of intolerance to implanted devices;

- Not ambulatory; and

- Participation in another clinical trial within 8 weeks of the Screening Visit and for
the duration of this trial.