Lap-Band Post Approval Study Completed

Apollo Endosurgery says it has completed a post-approval study of its Lap-Band AP Adjustable Gastric Band called HERO (Helping Evaluate Reduction in Obesity). The study began in 2009 as part of CDRH’s approval conditions for the device, which is indicated for weight reduction in obese patients.

The multi-center, prospective, non-randomized study involved 652 patients and a primary endpoint involving the percentage of patients who experienced device removal within or at five years from the date of surgery (the explant rate). “The successful primary endpoint, as defined in this study, was a significantly lower explant rate than the 39.4% found in initial Lap-Band System clinical studies, which are cited in the Lap-Band System Directions for Use,” the company says. HERO had an explant rate of 8.74%, which met the success criteria for the primary endpoint, it says.