Apollo Endosurgery Successfully Completes LAP-BAND FDA Post-Approval Study

Apollo Endosurgery Inc., a developer of minimally invasive surgical products for bariatric and gastrointestinal procedures, announced the completion of the LAP-BAND AP Adjustable Gastric Band HERO (Helping Evaluate Reduction in Obesity) Post-Approval Study. This study was initiated in June 2009 as part of the FDA’s condition of approval for the LAP-BAND System in the United States.
 
The HERO Study was a multi-center, prospective, non-randomized study of 652 enrolled patients in the U.S. and Canada. Patients were required to have either a baseline body mass index (BMI) of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more severe co-morbid conditions, or be at least 100 pounds (45.4 kg) over their estimated ideal weight. Patients had an average age of 44.4 years (ranging from 18 to 76) with an average baseline weight of 280.7 lbs. (127.3 kg) and an average BMI of 45.4 kg/m2. Females represented 79.3% of the patients.
 
The primary endpoint, or measurement of the study, was the percentage of patients who experienced the removal of the LAP-BAND AP System 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 HERO Study had an explant rate of 8.74%, which met the success criteria for the primary endpoint.
 
The average percent total body weight loss (TBWL) for the enrolled patients increased progressively within the first year of LAP-BAND AP placement, increasing from an average of 10.3% at three months to 17% TBWL at the end of the first year. At the five-year visit, the average TBWL was 18%. Mean weight loss from baseline to five years was 51 lbs. (23.1 kg) and mean BMI reduction was 8.3 kg/m2.
 
One of the lead investigators, John Olsofka, M.D., stated, “This study demonstrates that continued patient interaction and adherence to good LAP-BAND aftercare principles by the surgeon’s practice will produce an effective, safe, and durable outcome for patients who suffer from obesity.” Vincent Lusco, M.D., another lead investigator commented, “As the HERO Study shows, the key to success with LAP-BAND is for it to be viewed as a therapy as much as a surgical procedure. When delivered by bariatric surgeons who have the required aftercare program, laparoscopic adjustable gastric banding with the LAP-BAND is an excellent alternative for patients looking to gain control over obesity.” Both Drs. Olsofka and Lusco operate at LAP-BAND of Louisville Surgical Associates in Louisville, Kentucky.
 
“The results demonstrated in the HERO Study are consistent with what we see at bariatric practices who have appropriately tailored and prescriptive follow-up programs for their patients,” said Todd Newton, CEO of Apollo Endosurgery. “We remain confident that the LAP-BAND System is a great option for patients seeking medically-relevant weight loss results at bariatric practices where these tailored follow-up programs are in place.”