San Diego-based Obalon Therapeutics earned Food and Drug Administration approval for its Obalon Balloon System, a nonsurgical weight loss device for patients who failed to lose weight through diet and exercise.
The Obalon Balloon System works by having a patient swallow a balloon folded inside of a capsule. Once ingested, the balloon is inflated inside the stomach using a micro-catheter. Two additional balloons are swallowed and inflated in the patient's stomach over the next three months. After six months, all three balloons are removed via an outpatient endoscopy.
In a recent clinical trial involving 387 patients across 15 sites, participants either swallowed the Obalon Balloon System or three placebo devices that looked like balloons. At the end of the trial, about 65 percent of the patients treated with Obalon's system lost at least 5 percent of their body weight — twice as many people as in the control group.
The Obalon Balloon System will be available in early 2017 to physicians who complete a training program for the device.
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