A Medical Device Daily

Allergan (Irvine, California) said the FDA Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee has recommended with an 8-2 vote that the FDA extend the currently approved use of the Lap-Band System, Allergan's gastric band, on the basis of a favorable benefit-risk profile for weight reduction in obese adults who have failed more conservative weight reduction alternatives and have a Body Mass Index (BMI) of at least 35 or a BMI =30 and at least one comorbid condition.

“We are pleased with the committee's decision, which reflects consensus that there is a need for additional, effective treatment options for patients who are currently obese, given the known significant health ramifications of obesity,“ said Frederick Beddingfield, MD, VP of clinical R&D for Allergan. “Given the health risks of even moderate levels of obesity, it is important to have other treatment options for patients when other attempts at weight loss have proven unsuccessful.“

The committee's decision followed a review of the currently unmet clinical needs among the obese patient population, as well as 12-month data from a prospective, single-arm, non-randomized, multi-center five-year study involving 149 obese patients, who on average had been obese for 17 years, treated with the Lap-Band System, numerous publications, and the more than 17-year safety and effectiveness record of the Lap-Band System.

The Lap-Band system study, initiated by Allergan, is a prospective, single-arm, non-randomized, multi-center five-year study. The study was initiated in 2007, and included 149 patients who underwent the Lap-Band system procedure. The 12-month primary endpoint data was presented at committee, along with relevant two-year data requested by the Agency.