Apollo Endosurgery Reports Trial Results for Lap-Band

Austin, Texas-based Apollo Endosurgery Inc., which makes endoscopic surgical products for bariatric and gastrointestinal procedures, has received results from a multicenter pivotal study detailing five-year health outcomes for Lap-Band patients with a body mass index (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 percent, corresponding with 62.7 percent 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 percent improvement in diabetes, 64.4 percent improvement in dyslipidemia, and 59.6 percent improvement with hypertension.

The device explant rate was 14.8 percent, which was substantially below the study’s safety objective of less than 32.5 percent 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 percent at 5 years.

No unanticipated adverse device events were reported.

“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, M.D., 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. “This study indicates that surgical therapy like gastric banding should be considered a treatment option for patients with a BMI as low as 30 to stop or slow the progression of obesity and associated co-morbidities.”

“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,” added Dennis McWilliams, president and chief commercial officer of Apollo Endosurgery.

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 percent of patients achieved and sustained at least 30 percent EWL lost during the study period which substantially exceeded the primary effectiveness endpoint of at least 40 percent of subjects losing at least 30 percent 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.