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The Hemospray device delivers an aerosolized spray that delivers a mineral blend to the bleeding site.
Marketing of the Hemospray, a new Wilson-Cook Medical device used to help control certain types of bleeding in the gastrointestinal (GI) tract, has been permitted by the FDA, according to an announcement made by the agency.
“The device provides an additional, nonsurgical option for treating upper and lower GI bleeding in certain patients, and may help reduce the risk of death from a GI bleed for many patients,” said Binita Ashar, MD, and director, division of surgical devices in the FDA’s Center for Devices and Radiological Health, in a press release.
Bleeding can occur in the upper or lower GI tracts. Causes of GI bleeding include gastric ulcers, artery or vein malformations, diverticulosis, cancer, or inflammatory bowel disease. Older patients are at a higher risk of death from severe GI bleeding.
The Hemospray device is intended to treat most types of upper or lower GI bleeding. The device delivers an aerosolized spray that applies a mineral blend to the bleeding site. It is utilized during an endoscopic procedure, and can cover large areas, such as ulcers or tumors. The device is not intended for use in patients with variceal bleeding, which is bleeding that comes from enlarged veins that develop in certain medical conditions, such as alcoholic liver disease.
The FDA reviewed data from clinical studies consisting of 228 patients with upper and lower GI bleeding, supplemented with real world evidence from medical literature reports that included an additional 522 patients. The Hemospray device stopped GI bleeding in 95% of patients within 5 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.
One serious adverse 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.
FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding [news release]. FDA website: Silver Spring, MD; May 7, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm606799.htm. Accessed May 7, 2018.