The U.S. Food and Drug Administration (FDA) has approved the Apollo Endosurgery's ORBERA Intragastric Balloon to assist adult patients suffering from obesity.
The company, a leader in minimally invasive endoscopic surgical products for bariatric and gastrointestinal procedures, in a press release, said that the balloon helps people with a body mass index (BMI) of 30 to 40 - in losing and maintaining weight.
The balloon is part of the ORBERATM Managed Weight Loss System, a non-surgical two-part program that includes a balloon filling space in a patient's stomach to reinforce proper portion control.
According to the company, in the clinical trial of the system has shown that the average person can lose 3.1 times the weight as compared with diet and exercise alone within six months.
"While new to the United States, ORBERA is a weight loss device with more than 220,000 balloons distributed in over 80 countries and approximately 230 published papers documenting its clinical results," said Todd Newton, Chief Executive Officer of Apollo Endosurgery.
Newton also said that the balloon is a proven, innovative and non-surgical solution to help fight the obesity epidemic and treat patients before their disease progresses and requires more invasive treatments.
"With the FDA approval, Apollo can now offer this safe and effective solution to patients and their physicians in the United States," Newton added.