The FDA has approved a non-surgical weight loss device for adults with obesity and have a body mass index of 30 kg/m2 to 40 kg/m2, according to a press release.
“Those of us who participated in the pivotal trial have the firsthand experience with the TPS device and were pleased with its patient outcomes,” Richard Rothstein, MD, chair of the department of medicine at the Geisel School of Medicine at Dartmouth, said in the release. “In addition to the clinically meaningful weight loss seen in the study group who received the device, we also observed cardio-metabolic improvements in that cohort. We are excited to see that the device is approved by the FDA and look forward to using it in our clinical practice.”
The approval of the TransPyloric Shuttle (TPS) Device (BARONova), according to the release, is a result of data from the ENDObesity II trial. The randomized, double-blind and sham-controlled trial comprised 302 patients treated with the TPS device. These patients lost on average 3.4 times more weight than the individuals in the sham-control group (P < .0001) at 12-month follow-up, according to the release.
Additionally, approximately 67% of patients treated with the device lost at least 5% or more of their body weight, which exceeded the study’s primary endpoint target of 50% (P < .0001).
Gastrointestinal side effects such as stomach pain, nausea, vomiting and dyspepsia were the most common side effects that patients reported.
The approval is for up to 12 months of treatment, at which time patients should receive lifestyle modification counseling to help develop and maintain healthier habits, according to the release.
Delivered and retrieved endoscopically from the stomach, the device is 85% to 90% smaller than fluid-filled balloons and is designed to slow the passage of food so patients feel full sooner and stay full longer.
“The vast majority of patients with obesity are left untreated today,” Wayne J. English, MD, clinical trial research director at the Vanderbilt University Weight Loss Center, said in the release. “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. The TPS device design addresses some of the limitations with the first-generation intragastric devices and offers longer treatment duration which is clinically attractive.”