FDA Approves Non-Surgical Obesity Treatment Device

The US Food and Drug Administration (FDA) has approved the TransPyloric Shuttle Device, a non-surgical tool for adults with obesity who have a body mass index (BMI) of 30 to 40 kg/m². The device may be used for up to 12 months alongside lifestyle modification counseling.

The TransPyloric Shuttle device (TPS) is placed and removed from the stomach endoscopically. Once in place, it is about 5.6 cm in diameter, 85% to 90% smaller than fluid-filled intragastric balloons.

"The vast majority of patients with obesity are left untreated today. Endoscopically delivered intragastric devices can help close the obesity treatment gap and offer alternative options for qualified patients who are not eligible, or unwilling, to undergo metabolic and bariatric surgery," said Wayne English, MD, Associate Professor of Surgery, Clinical Trial Research Director at Vanderbilt University Weight Loss Center, and a principal investigator for the ENDObesity II study.

English added that the TPS device is an improvement over certain limitations of previous intragastric devices, including offering longer treatment duration. The TPS device is approved for 12 months of use, twice as long as intragastric balloons that are approved in the US.

The FDA’s decision to approve the TPS device was supported by results from the ENDObesity II trial.

The ENDObesity II study included 302 participants who were randomized to either receive the TransPyloric Shuttle or a sham procedure. Both groups also received lifestyle counseling to encourage a reduced calorie diet and increased physical activity. Participants had a BMI of 30 to 40 kg/m² and those with BMI of 30 to 34.9 kg/m² had at least one obesity-related comorbidity.

Patients who received the TPS device lost on average 3.4 times more weight than those in the sham group at 12 months. The TPS group lost 9.5% of their body weight compared to 2.8% for the sham group (P <.0001). Additionally, 67% of those treated with TPS lost ≥5% body weight, and 40% lost ≥10% of their body weight compared to 14% of the sham group.

In addition to weight loss, participants treated with the study device experienced improvements in blood pressure, other cardiometabolic risk factors, and quality of life measurements.

The most common adverse events noted in the study among the TPS-treated group were gastrointestinal events, such as stomach pain, nausea, vomiting, and dyspepsia.

"Those of us who participated in the pivotal trial have the firsthand experience with the TPS device and were pleased with its patient outcomes," said Richard Rothstein, MD, the Joseph M. Huber Professor and Chair of Medicine for the Dartmouth Geisel School of Medicine, and the lead investigator for the ENDObesity II study.