FDA approves TransPyloric Shuttle device for obesity

BAROnova announced that the FDA has approved the TransPyloric Shuttle (TPS) Device, a non-surgical weight loss solution for adult individuals suffering from obesity with a body mass index (BMI) of 30 to 40 kg/m2. The device is approved for up to 12 months of treatment, during which time patients undergo lifestyle modification counseling to help develop and maintain healthier habits.

The approval of the TPS is based on data from its pivotal trial (ENDObesity II study), a randomized, double-blind, and sham-controlled study that enrolled 302 patients from nine investigational centers across the United States. Patients treated with the TPS device on average lost 3.4x more weight when compared to the sham-control group (9.5% for the TPS group and 2.8% for the Control, p<0.0001) at the 12-month follow up. Approximately 67% of people treated with TPS lost 5% or more of their body weight, exceeding the study endpoint target of 50% (p<0.0001). Forty percent (40%) of people treated with TPS lost 10% or more weight (vs. 14% in sham-treated controls).

A weight loss of 5% or more is considered clinically meaningful for achieving important health benefits. Improvements in blood pressure and other cardiometabolic risk factors as well as quality of life were also observed with TPS treatment. The most common adverse events among people treated with the TPS device were gastrointestinal events, such as stomach pain, nausea, vomiting, and dyspepsia, as expected with an intragastric device designed to treat obesity through delayed gastric emptying.