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# Vibrant Gastro Colon Vibrator Gets Authorization
- URL: https://www.fdaweb.com/vibrant-gastro-colon-vibrator-gets-authorization/
- Published: 2022-09-02T12:00:00.000Z
- Updated: 2026-09-14T17:58:15.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152663

FDA has granted Vibrant Gastro de novo marketing authorization for its Vibrant, an orally administered drug-free capsule for treating adults with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month. Vibrant is believed to work through mechanical stimulation of the colon, the company says. The stimulation is intended to resynchronize the body’s biological clock to improve daily bowel movement biorhythm.

The marketing authorization was based on pivotal clinical trial results from 312 chronic idiopathic constipation patients, the company says. “The pivotal trial’s outcomes demonstrated superiority with respect to both the proportion of patients with at least one additional complete spontaneous bowel movement per week compared to baseline — 40.51% in the treatment arm compared to 22.92% in the control arm…”, it says, adding that it also showed two additional complete bowel movements per week for 23.42% of patients in the treatment arm compared to 11.81% of those in the control arm.