Stomach Balloons Promote Rapid Weight Loss

The ReShape Duo dual-intragastric balloon is endoscopically placed down the esophagus and into the stomach where they take up much of the stomach’s volume, causing patients to eat smaller portions and to feel full sooner. The device does not change or alter the patient’s anatomy and is fully reversible. During the 24-week treatment period, patients work with dieticians, doctors, and nurses to learn healthy diet and exercise habits to help them during and beyond the treatment period.

The procedure involves placement under deep conscious sedation, using an endoscope inserted through the mouth. The uninflated balloons are advanced over a guide wire and are precisely placed in the stomach, and each balloon is inflated independently with saline. The device is release and remains in the stomach for six months, serving as built-in portion control. Once done, an endoscope is again used to stabilize the balloons and fit a proprietary suction cap to completely drain the balloons in a controlled manner. A snare then securely lassos the deflated dual balloon around the flower tip, and the device is removed through the mouth.

The clinical REDUCE Trial for the device has met its primary efficacy endpoints in a randomized, sham-controlled pivotal trial for weight loss. Study endpoints assessed weight loss and responder rates. The trial, which reached full enrollment in less than six months, involved eight US sites and studied 326 patients, and the device is slated for premarket approval application by the US Food and Drug Administration (FDA) in the second quarter of 2014. The ReShape Duo dual-intragastric balloon is under development by ReShape Medical (San Clemente, CA, USA).

“Being the first device company to meet its primary efficacy endpoints in a randomized obesity trial is an important step forward on the path to FDA approval,” said Richard Thompson, president and CEO of ReShape Medical. “ReShape Duo has the potential to help patients lose significantly more weight than diet and exercise programs alone.”

“Meeting the primary endpoints is an important accomplishment, as it convincingly demonstrates the superiority of the ReShape procedure over diet and exercise,” said Jaime Ponce, MD, principal investigator in the REDUCE trial. “The ReShape procedure offers a new alternative to help patients kick-start weight loss and learn new behaviors. We are excited about what this new treatment option may do for millions of people needing to lose excess weight.”

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