Apollo Endosurgery, a leader in minimally invasive endoscopic surgical products for bariatric and gastrointestinal procedures, announced the results from a multicenter pivotal study detailing five-year health outcomes for LAP-BAND patients with a BMI between 30-39.9.
The study showed sustained long term weight loss over the 5 year period. Average percent weight loss at five-years was 15.9 +/-12.4%, corresponding with 62.7% excess weight loss (EWL).
Patients showed significant improvement in their co-morbid conditions at the end of the 5 year period strengthening the previously released data of 85.7% improvement in diabetes, 64.4% improvement in dyslipidemia, and 59.6% improvement with hypertension.
No unanticipated adverse device events were reported.
The device explant rate was 14.8% which was substantially below the study’s safety objective of less than 32.5% at 5 years. Excluding patients who elected to exercise their option to have the band removed at no cost to them on completion of the study, the explant rate was 5.4% at 5 years.
"Surgical intervention like gastric banding in this study can provide durable weight loss and significant improvements in pre-existing co-morbid conditions and quality of life in the right patients, right hands and the right places," said John Morton, MD, Director of Bariatric Surgery at Stanford University Hospital and Clinics, Chief of Bariatric Surgery at Stanford University Medical Center and current President of the American Society of Metabolic and Bariatric Surgery.
Dennis McWilliams, President and Chief Commercial Officer of Apollo Endosurgery, added, "The LAP-BAND AP System is safe and effective for patients with a BMI of 30 or higher, that delivers sustained weight loss, improvements in quality of life, reduced cardiometabolic risk when combined with reasonable and proper physician follow-up with their patient."
The five-year pivotal study, published in the International Journal of Obesity, tracked the health outcomes for 149 LAP-BAND® patients from six U.S. states with a BMI of 30 to 39.9. Results showed that 76% of patients achieved and sustained at least 30% EWL lost during the study period which substantially exceeded the primary effectiveness endpoint of at least 40% of subjects losing at least 30% of their excess body weight.
Patients were followed up after surgery eight times the first year, four times in the second year and twice per year thereafter.
Traditionally, weight loss surgery is indicated for use in weight reduction for severely obese patients with a BMI of 35 or higher while the LAP-BAND® is approved for patients with a BMI as low as 30 with one or more severe co-morbid conditions.
The LAP-BAND® System is placed laparoscopically in a minimally invasive procedure to assist in gradual weight loss. The LAP-BAND® System is fastened around the top of the stomach, and works by applying a constant, gentle pressure to this area. This gives you a feeling of satiety (a feeling of fullness) on a smaller amount of food, therefore you eat less.