Medical devices maker Apollo Endosurgery has completed the LAP-BAND AP adjustable gastric band HERO (Helping Evaluate Reduction in Obesity) FDA post-approval study.
The company started the trial in June 2009, as part of the FDA’s condition of approval for the system in the US.
LAP-BAND AP adjustable gastric band will be placed laparoscopically in a minimally invasive procedure to help in gradual weight loss.
The system, which is fixed around the top of the stomach, works by applying a constant and gentle pressure in the stomach area.
The HERO trial was a multi-center, prospective and non-randomized study of 652 enrolled patients in the US and Canada.
Patients in the trial 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.
The primary endpoint or measurement of the study was the percentage of patients who underwent the removal of the LAP-BAND AP system within or at five years from the date of surgery (the explants study)
According to the company, the primary endpoint showed a lower explant rate than the 39.4% found in initial LAP-BAND system clinical studies.
The trail reached an explant rate of 8.74%, demonstrating the success criteria for the primary endpoint.
Apollo Endosurgery CEO Todd Newton said: “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.
“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.”