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# De Novo Marketing of Device Spray for GI Bleeding
- URL: https://www.fdaweb.com/de-novo-marketing-of-device-spray-for-gi-bleeding/
- Published: 2018-05-07T12:00:00.000Z
- Updated: 2026-09-15T00:03:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141379

FDA has permitted the de novo marketing of Wilson-Cook Medical’s Hemospray, a new device used to help control certain types of bleeding in the gastrointestinal (GI) tract. The device is an aerosolized spray that delivers a mineral blend to the bleeding site. It is applied during an endoscopic procedure and can cover large areas such as large ulcers or tumors. The device is not intended for use in patients with variceal bleeding, an [FDA notice](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm606799.htm?ref=fdaweb.com) says.

The marketing decision was based on data from clinical studies involving 228 patients with upper and lower GI bleeding, supplemented with real world evidence from medical literature reports including an additional 522 patients, the agency says. “The Hemospray device stopped GI bleeding in 95% of patients within five minutes of device usage. Re-bleeding, usually within 72 hours, but up to 30 days following device usage, was observed in 20% of these patients,” it says. One serious side effect, bowel perforation, was observed in approximately 1% of patients. Hemospray is contraindicated in patients who have a gastrointestinal fistula or are at high risk for experiencing a gastrointestinal perforation.”