FDA Approval of Apollo Endosurgery ORBERA™ Intragastric Balloon

A specialist company in minimally invasive endoscopic surgical products for bariatric and gastrointestinal procedures, Apollo Endosurgery, Inc., has gained U.S. FDA approval for its ORBERA™ Intragastric Balloon to assist adult patients suffering from obesity to lose and maintain weight.


The ORBERA™ balloon is part of Apollo Endosurgery’s Managed Weight Loss System of the same name. This takes the form of a comprehensive, non-surgical two-part program that includes a balloon filling space in a patient’s stomach to reinforce proper portion control.

ORBERA™ is an incision-less, non-surgical weight loss solution designed for adult patients suffering from obesity, who are not appropriate for or considering invasive surgery, but for whom diet and exercise or pharmaceutical interventions have not worked.

In an endoscopic procedure done under a mild sedative, the thin and deflated ORBERA™ balloon is placed into the stomach, then filled with saline until it’s about the size of a grapefruit. The procedure typically takes about 20 to 30 minutes and the patient can generally go home the same day. At six months, through another non-surgical procedure done under a mild sedative, the ORBERA™ balloon is deflated and then removed.

Data on ORBERA™ collected in the U.S. clinical trial has shown that the average person lost 3.1 times the weight as compared with diet and exercise alone within six months.

Company comments

“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. “ORBERA™ 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 of ORBERA™, Apollo can now offer this safe and effective solution to patients and their physicians in the United States.”

Physician comments

“For many, the weight loss journey leaves patients with little support or options other than diet and exercise and traditional surgery. The approval of ORBERA™ fills this gap in available treatments and is an exciting development for healthcare professionals who are committed to providing patients with less invasive options that can assist them in reaching their long-term weight loss goals,” said Christine Ren-Fielding, M.D., a New York-based bariatric surgeon.

“ORBERA™ gives us a new weight loss option to help address what has become a critical health issue in the United States.”

Source: Business Wire


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