Apollo Endosurgery (NSDQ:APEN) has won approval in South Korea for its Orbera intragastric weight-loss balloon system.
The Orbera system includes a silicone balloon that is placed into a patient’s stomach endoscopically and filled with saline. The balloon is designed to lessen the patient’s stomach capacity and thereby reduce the amount of food that the patient can consume.
In South Korea, Apollo Endosurgery has an exclusive distribution deal with Shin Han Systek Co. for the Orbera balloon.
After Apollo’s balloon is placed in a patient’s stomach, the patient works with their doctor as part of a lifestyle modification program to meet long-term goals. Although the Orbera device is removed after six months, the coaching program continues for 12 months to help patients create sustainable weight-loss habits.
After six months has passed, the Orbera balloon is deflated and removed through a non-surgical procedure, according to Apollo.
In August last year, the company won an expanded CE Mark approval in the European Union for its system, extending the indwell period of the balloon from 6 months to 12 months.
