|ReShape Integrated Dual Balloon System--Courtesy of ReShape Medical|
ReShape Medical's Integrated Dual Balloon System just burst regulatory barriers, becoming the first device of its kind to earn the FDA's stringent PMA approval for novel, high-risk devices. The Fierce 15 company's device consists of two salt water-filled silicon balloons that reduce appetite by taking up space in the stomach "or by other mechanisms that are not yet fully understood," according to the FDA.
Indeed, the Dual Balloon is a new treatment paradigm in the fight against obesity, which includes just three other FDA-approved devices.
"For those with obesity, significant weight loss and maintenance of that weight loss often requires a combination of solutions including efforts to improve diet and exercise habits," said Dr. William Maisel, acting director of the Office of Device Evaluation at the FDA's device arm (CDRH), in a statement. "This new balloon device provides doctors and patients with a new non-surgical option that can be quickly implanted, is non-permanent, and can be easily removed."
Unlike invasive weight-loss surgery, which can involve risks like malnutrition following a duodenal switch, involving removal of most of the stomach, the Dual Balloon is inserted through the mouth via an endoscope in a minimally invasive manner. The FDA says the procedure takes less than half an hour and requires mild sedation.
The device is indicated for obese adults with a Body Mass Index of 30 to 40 kilograms per square meter. Patients must have high blood pressure, high cholesterol or diabetes, all obesity-related maladies. In addition, the Dual Balloon is for those who failed at weight loss via dieting and exercise alone. It's also contraindicated for patients with certain diseases and conditions.
ReShape says Dual Balloon patients are supposed to receive weight-loss counseling, including in-office coaching sessions.
In a clinical trial of 326 obese patients, those randomly selected for the Dual Balloon lost an average of 14.3 pounds after using the device for 6 months, while the control group lost an average of 7.2 pounds. And 6 months after the Dual Balloon was removed, the treatment group had lost nearly 10 pounds, meaning they kept off most of the weight that was lost while on the device.
Side effects for the procedure include headache, muscle pain and nausea from the sedation and procedure, the FDA says. Once inserted in the stomach, possible side effects include vomiting, nausea, abdominal pain, gastric ulcers and feelings of indigestion.
The device previously earned a CE mark in Europe, where it's been available since 2011, along with a few other weight-loss balloons. "While intragastric balloons have been used successfully outside of the U.S. for many years, there has been little design improvement or innovation of this treatment," said ReShape Medical CEO Rick Thompson in a statement. "We looked closely at previous balloons when designing our dual balloon and we feel confident that our unique, next-generation design will help to deliver sustained results and significant life changes for patients."
Features include the use of two balloons instead of one and the use of a flexible shaft on which to mount the balloons that increases comfort when the device is placed in the patient's stomach. ReShape says the Dual Balloon is the only one designed to mitigate the potential of a deflated a balloon entering the intestines. The device is filled with methylene blue dye that will appear in the patients' urine if it bursts.
|Orbera intragastric balloon--Courtesy of Apollo Endosurgery|
Competitor Apollo Endosurgery is also awaiting word from the FDA on the status of its PMA application for its weight-loss balloon. The company said during the Digestive Disease Week conference in Washington, DC, that in its pivotal clinical trial, the Orbera doubled weight loss compared to diet and exercise alone.
In June, Obalon Therapeutics announced the completion of enrollment of a pivotal trial for its weight-loss balloon and hopes to file for FDA approval by the end of the year. And Allurion Technologies claims its investigational device is procedureless because the balloon is inserted into the body via a swallowed capsule and excreted out of the body at the end of the treatment period.
The currently approved obesity devices include a nerve blocker made by EnteroMedics, and two adjustable gastric bands, including the Lap-Band. Apollo acquired that device from Allergan ($AGN) in 2010, with the intention of turning the struggling franchise around.
But in a prior interview Apollo President Dennis McWilliams said that while obesity has skyrocketed, the number of surgeries to treat it is staying fairly constant, and used on less than 1% of the eligible patient population. The upcoming class of intragastric weight-loss balloons is "opening up a whole new category in this space that's less invasive," he said, because they provide an incisionless, minimally invasive, procedural (rather than surgical) option.
The American Society for Metabolic and Bariatric Surgery touted the approval in a release. "We are at the dawn of a new age in obesity treatment with the addition of this safe and effective treatment option," said the society's president Dr. John Morton, the director of the Bariatric and Metabolic Inter-Disciplinary Clinic at Stanford Health in California, in a statement "Much like cardiac disease, we are seeing demonstration of the full continuum of care for obesity from primary prevention and FDA-approved medications to the endoscopic ReShape Dual Balloon to established, effective bariatric surgery procedures. The ReShape Dual Balloon offers a bridge between medications and surgery similar to a cardiac stent in cardiac disease."
- read the release from FDA
- here's the company release
- here's the American Society for Metabolic and Bariatric Surgery's take
Special Report: FierceMedicalDevices' 2014 Fierce 15 - ReShape Medical
Editor's Note: This story has been updated with a statement from the president of the American Society for Metabolic and Bariatric Surgery