Apollo Endosurgery nabbed an FDA approval for its Orbera Intragastric Balloon in August--which was the third obesity device approved by the agency this year. But Apollo isn't relinquishing its grip on long-standing obesity device Lap-Band, which has faced critiques both on safety and efficacy.
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| Lap-Band--Courtesy of Apollo |
The newly approved devices include two gastric balloons: Orbera and another from competitor ReShape Medical. The agency also signed off on a controversial neurostimulation implant from EnteroMedics ($ETRM) earlier this year.
In the latest Lap-band data in 149 Lab-Band patients with a BMI of 30 to 39.9 after 5 years, patients had maintained average weight loss of 15.9%--but that was hugely variable among individuals with a range of +/- 12.4%. And after 5 years, subjects were able to maintain an average of about 63% of the excess weight loss they had achieved.
Roughly three-quarters of these Lap-Band patients reported that they had sustained excess weight loss of at least 30% during the 5 years. The primary endpoint in the study had anticipated that at least 40% of them would do so. The study also found that after 5 years almost 15% of the study patients had already had their Lap-Bands removed.
On health outcomes, patients also further strengthened upon their previously disclosed demonstrated benefits of 86% with improved diabetes, 65% with improved dyslipidemia and 60% with improved hypertension.
"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," Dr. John Morton, director of bariatric surgery at Stanford University Hospital and Clinics, chief of bariatric surgery at Stanford University Medical Center and president of the American Society of Metabolic and Bariatric Surgery, said in a statement.
He added, "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."
The Lap-Band was first approved by the FDA in 2001 for use in severely obese patients with a BMI of at least 40; for those with a BMI of at least 35 in addition to severe related condition such as heart disease or diabetes; or for those who were at least 100 pounds overweight. In 2011, the agency expanded that approval to include patients with a BMI of 30 to 34 with an existing condition related to obesity.
- here is the announcement
- and here is the study