FDA Approves TransPyloric Shuttle Intragastric Device for Obesity

Marlene Busko

Disclosures

April 24, 2019

The US Food and Drug Administration (FDA) has approved the TransPyloric Shuttle (TPS) intragastric device to help eligible obese patients lose weight, the manufacturer, BAROnova, has announced.

Clearance of the shuttle (and TPS delivery device used to implant/explant it) is based on the safety and efficacy findings from the pivotal phase 3 ENDObesity II study presented at Obesity Week 2018 in November, as previously reported by Medscape Medical News.

The intragastric device is endoscopically implanted into the stomach to help patients feel full sooner and then endoscopically explanted after a year.

It differs from first-generation inflatable intragastric balloons in that it is made of silicone (so is purported to keep its shape better) and is 85% to 90% smaller (the size of a peach).

It is also left in place twice as long (12 months), which gives patients, who also receive lifestyle counseling, longer to adopt new healthier eating habits — as they feel discomfort if they eat too much when the device is in place.

"Those of us who participated in the pivotal trial have the firsthand experience with the TPS device and were pleased with its patient outcomes...and look forward to using it in our clinical practice," said the lead investigator of the ENDObesity II study, Richard I. Rothstein, MD, Dartmouth Geisel School of Medicine, Lebanon, New Hampshire, in a statement from the company.

"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," added principal study investigator Wayne J. English, MD, Vanderbilt University Weight Loss Center, Nashville, Tennessee, noting that most patients with obesity are not treated.

The design of the TPS device, he said, "addresses some of the limitations with the first-generation intragastric devices and offers longer treatment duration, which is clinically attractive."

This is a first-in-class, nonsurgical solution that offers patients potentially more durable weight loss and health benefits, according to the company.

Postmarketing studies may provide "further validation of potential comorbidity benefits, like cardiometabolic improvement observed in the pivotal study, [which] may translate to important advantages in achieving healthcare coverage for the TPS device in the future," according to Lian Cunningham, MD, PhD, senior vice president of Clinical Affairs and Regulatory Affairs, BAROnova.

Phase 3 Trial of Safety, Efficacy Included 302 Patients

The ENDObesity II study randomized 270 mainly women in their mid-40s with a mean body mass index (BMI) of 36 kg/m2 at nine US sites to receive TPS or a sham device. An additional 32 patients then received a tweaked device for further safety data.  

At the study end at 12 months, the 181 patients who had received the TPS device had lost 9.5% of their initial weight, whereas the 89 patients who received a sham device lost 2.8% of their initial weight (P < .001).

Of patients who underwent the TPS procedure, 67% lost at least 5% of their initial weight (compared to 59.5% with sham; P < .001).

And 39.5% of people treated with TPS lost at least 10% or more weight (compared to 14% with sham; P = .0001).

Patients in the TPS group had improved blood pressure and other cardiometabolic risk factors, as well as quality of life.

The most common adverse events with the TPS device were gastrointestinal, such as stomach pain, nausea, vomiting, and dyspepsia, "as expected with an intragastric device designed to treat obesity through delayed gastric emptying," according to the company statement.

Only 2.8% of patients experienced serious adverse events (one patient each with esophageal rupture, upper abdominal pain, gastric ulcer, vomiting, and gastric obstruction), which all resolved.

The FDA approval states that "the TransPyloric Shuttle/TransPyloric Shuttle delivery device is used in obese adult patients with a BMI of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with an associated medical condition (for example, diabetes) who have been unable to lose weight [with a] diet and behavior modification program, and exercise. It is intended to be used while a patient participates in a diet and exercise plan supervised by a healthcare provider."

The study was funded by BAROnova.

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