Study Findings Revealed As US Gastric Band Market Expands
by Pharmacy Life - Published on 12 October 2015
Apollo Endosurgery has reacted to doubts over the safety and efficacy of its obesity device, Lap-Band, by announcing the results of a multicentre pivotal study, which detailed five-year health outcomes for Lap-Band patients with a BMI between 30-39.9.
Apollo recently gained approval by the Food and Drug Administration (FDA) for its Orbera Intragastric Balloon – which was the third obesity device to be approved by the agency this year. (FDA had also approved another gastric balloon by ReShape Medical and a controversial neurostimulation implant from EnteroMedics.) Apollo had, however, been stung by criticism in 2011 by FDA of its advertising claims for Lap-Band.
‘FDA’s concern is that these ads glamorize the Lap-Band without communicating any of the risks,’ Steven Silverman, director of the Office of Compliance in FDA’s Center for Devices and Radiological Health said at the time. ‘Consumers, who may be influenced by misleading advertising, need to be fully aware of the risks of any surgical procedure.’
As a result, Apollo launched the study of 149 Lap-Band patients, which showed sustained long-term weight loss over the five-year period. Average per cent weight loss at five years was 15.9 per cent, but the figures were hugely variable with a range of +/- 12.4 per cent. After five years, patients were able, on average, to maintain about 63 per cent of their weight loss.
Patients showed significant improvement in their co-morbid conditions at the end of the five- year period strengthening the previously released data of 85.7 per cent improvement in diabetes, 64.4 per cent improvement in dyslipidemia, and 59.6 per cent improvement with hypertension. The study also showed that no unanticipated adverse device events were reported.
‘Surgical intervention like gastric banding in this study can provide durable weight loss and significant improvements in pre-existing co-morbid conditions and quality of life in the right patients, right hands and the right places,’ said John Morton, MD, Director of Bariatric Surgery at Stanford University Hospital and Clinics, Chief of Bariatric Surgery at Stanford University Medical Center and current President of the American Society of Metabolic and Bariatric Surgery. ‘This study indicates that surgical therapy like gastric banding should be considered a treatment option for patients with a BMI as low as 30 to stop or slow the progression of obesity and associated co-morbidities.’