The FDA has approved Apollo Endosurgery’s latest product: a minimally invasive gastrointestinal balloon to combat obesity.
The Orbera device is inserted through a patient’s mouth into the stomach where it is inflated and filled with saline. Dennis McWilliams, Apollo’s founder, president and chief commercial officer, says the device is a sort of mid-point therapy to combat obesity, in between diet and exercise, and more invasive procedures such as gastric bypass surgery.
“This helps us build a suite of products for the treatment of obesity,” he says. “Less than 1 percent of total population with obesity that is eligible for surgical intervention is getting treatment. This is like for cardiovascular patients waiting until a heart attack to get treated for heart disease.”
Founded in 2006, Apollo specializes in translumenal surgery, therapeutic endoscopy, and minimally invasive devices for GI procedures. The Austin, TX-based company last year acquired for $110 million the Lap-Band business from Allergan, a pharmaceutical company based in California best known for its Botox product line. Orbera, which is used in about 80 countries in more than 200,000 procedures around the world, was part of that product line.
This week, Apollo received the nod from the FDA allowing the device to be marketed to patients. The regulatory agency wants the company to do additional post-marketing studies and submit additional reports back to the FDA.
The Orbera balloon is inserted deflated through a patient’s throat using a catheter. Once inside, it is inflated to the size of a grapefruit. Apollo says the procedure takes about 30 minutes and that patients, who are under a mild sedative, normally can go home the same day. Six months later, the balloon is deflated and removed in a similar procedure to its insertion.
“The stomach is designed to expel things; it’s working really hard to push this object out,” McWilliams says. “That’s what leads to the time limit of these devices.”
Moreover, he adds that, clinical studies show diminishing returns in terms of weight loss after six months due to the presence of such balloons. “It’s really about diet and exercise at that point,” McWilliams says.
To help patients do that, Orbera includes a treatment regimen of a year’s counseling from a dietician, psychologist, and exercise physiologist—depending on the patient’s needs. The idea is to help patients stay motivated, work through any weight-loss barriers they have, and create healthy habits that will last well beyond the device’s lifetime.
“Obesity is a complex disease,” McWilliams says. “A mechanical aid like a balloon can retrain them how to eat effectively.”