The FDA has approved the termination of the LAP-BAND® Lower Body Mass Index (BMI) Post-approval study (“LBMI Study”) announced today by Apollo Endosurgery, Inc.
In 2011, the U.S. FDA granted approval for an expanded indication for the LAP-BAND System to include patients with a BMI in the range of 30 to 35 and with one or more comorbid conditions. As part of this indication expansion, the manufacturer of LAP-BAND was required to conduct the LBMI Study, a prospective, multicenter, open-label, post-approval study intended to evaluate the safety and effectiveness of the LAP-BAND System in patients with BMI in the range of 30 to 39.9, with one or more obesity-related comorbidities and follow the patients up to 10 years after implantation. The LBMI Study design was to enroll up to 325 patients from up to 20 clinical study sites. As of the end of 2017, the study had enrolled 181 subjects from a total of 13 clinical study sites. The early termination of LBMI Study is expected to result in a cost savings of approximately $5.1 million dollars over its remaining term.
The FDA approved the early termination of the LBMI Study based upon the availability of long-term safety and effectiveness data of LAP-BAND in the lower BMI indication in existing published evidence. Apollo’s final study report to FDA included an analysis of published clinical data referencing 25 published studies, including the HERO-002 study which Apollo concluded in September of 2017 and reported LAP-BAND patients in the study had experienced:
- sustained long term weight loss over the five year period with the average percent TBWL at five-years of 18.0% plus or minus 12.7%, corresponding to 51.7% excess weight loss; and
- a device explant rate of 8.74% which was substantially below the study’s safety objective of less than 39.4% at five years.
HERO-002 was a prospective, five-year, single-arm, multi-center post-approval study of patients having a BMI ≥40 kg/m2, a BMI ≥ 35 with one or more severe co-morbid conditions, or were 100 pounds or more over their estimated ideal weight who decided to undergo implantation with the LAP-BAND® AP Adjustable Gastric Banding System. A total of 671 subjects were enrolled in the HERO-002 study at 17 sites across the United States and Canada. No unanticipated adverse device effects were reported in the HERO-002 study. The majority of adverse events were mild (70.3%) or moderate (23.7%) in severity. The most common device related adverse events were vomiting (33.0%), gastroesophageal reflux disease (20.6%) and dysphagia (22.3%). All device-related serious adverse events were resolved without sequelae.
About LAP-BAND®: The LAP-BAND® AP Adjustable Gastric Banding 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 a patient a feeling of satiety (a feeling of fullness) on a smaller amount of food, therefore, you eat less.
LAP-BAND can deliver sustained weight loss, improvements in quality of life, and reduced cardiometabolic risk when combined with reasonable and proper physician follow-up with their patient.