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Apollo completes Lap-Band post-approval HERO study
Apollo Endosurgery has 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 US.
The HERO Study was a multi-centre, prospective, non-randomised study of 652 enrolled patients in the US and Canada. Patients were required to have either a baseline body mass index (BMI) of at least 40, or a BMI of at least 35 with one or more severe co-morbid conditions, or be at least 100 pounds (45.4kg) 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 280.7lbs. (127.3kg) and an average BMI of 45.4. Females represented 79.3% of the patients.
The primary endpoint 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 (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.
“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,” said Dr John Olsofka, Louisville Surgical Associates, KY, and one of the lead investigators of the study.
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 51lbs (23.1kg) and mean BMI reduction was 8.3.
“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,” said Dr Vincent Lusco, another lead investigator, also from Louisville Surgical Associates. “When delivered by bariatric surgeons who have the required aftercare programme, laparoscopic adjustable gastric banding with the Lap-Band is an excellent alternative for patients looking to gain control over obesity.”
“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.”