Apollo Endosurgery Receives MFDS Approval for ORBERA Intragastric Balloon System in South Korea

Apollo Endosurgery Inc., a global developer of less invasive medical devices for bariatric and gastrointestinal procedures, has received South Korean Ministry of Food and Drug Safety (MFDS) approval for the ORBERA Intragastric Balloon System to help adult patients who are overweight (with a body mass index greater than 27) lose and maintain weight.
 
The ORBERA balloon is part of a comprehensive, non-surgical two-part program. The ORBERA System includes a silicone balloon that is filled with saline after endoscopic placement into a patient’s stomach. Once in the patient’s stomach, the balloon serves to reduce stomach capacity, causing patients to consume less food following the procedure, and delay gastric emptying, the primary mechanisms of action in assisting the patient in losing weight.
 
Studies have shown that Asians are more vulnerable to obesity complications including type 2 diabetes, dyslipidemia and hypertension. As a result, the Asia Pacific regional guidelines of the World Health Organization and International Obesity Task Force define obesity as BMI ≥ 25.0 [kg/m2]. Data published in 2017 from the National Health Insurance System of South Korea (NHIS) reported that more than 30 percent of adults in South Korea were considered moderately obese or severely obese (BMI ≥ 25.0 kg/m2). NHIS insures approximately 97 percent of the population in South Korea.
 
Shin Han Systek Co. Ltd. is the exclusive distributor for ORBERA in South Korea.
 
ORBERA is an incision-less, non-surgical weight loss solution designed for adult patients who are overweight or obese, who are not appropriate for or considering invasive surgery, but for whom diet and exercise or pharmaceutical interventions have not worked.

Learn more about ORBERA by watching the video below:

 

In a non-surgical (endoscopic) procedure, the thin and deflated ORBERA balloon is placed into the stomach. It is then filled with saline until it’s about the size of a grapefruit. The procedure typically takes about 20 minutes and the patient can generally go home the same day. At six months, through another non-surgical procedure, the ORBERA balloon is deflated and then removed.
 
Once the balloon is in place, the patient works with their physician and their staff in a formal lifestyle modification program to meet their long-term weight loss goals. Coaching takes place over 12 months, even though the balloon is removed after six months. The program is designed to help the patient develop sustainable, healthy habits that will help keep weight off over time.
 
For more than 20 years, the global medical community has been using intragastric balloons from the makers of ORBERA to help thousands of people lose weight. More than 277,000 ORBERA balloons have been distributed worldwide in over 70 countries.

Apollo Endosurgery Inc. is a medical device company focused on less invasive therapies for the treatment of obesity, a condition facing over 600 million people globally, as well as other gastrointestinal disorders. Apollo’s device based therapies are an alternative to invasive surgical procedures, thus lowering complication rates and reducing total healthcare costs. Apollo’s products are offered in over 70 countries today.