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# PMA Filed for Obesity Device
- URL: https://www.fdaweb.com/pma-filed-for-obesity-device/
- Published: 2018-07-17T12:00:00.000Z
- Updated: 2026-09-15T00:19:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141891

BAROnova has submitted a PMA for the TransPyloric Shuttle device intended for treating obesity. The device is trans-orally placed in the stomach during a standard endoscopic procedure and is intended to reside in the stomach for 12 months after which it is endoscopically removed. Its primary mechanism of action is delaying gastric emptying which is a known mechanism of weight loss, according to the company

  
The submission includes clinical data from the company’s pivotal trial, the ENDObesity II study. The randomized, double-blinded, sham-controlled study enrolled 302 patients from nine sites across the U.S., and it met its endpoints, BAROnova says. Results are expected to be presented at the Obesity Week conference in November.