GI bleeding can occur in the upper GI tract (esophagus, stomach or small intestine) or the lower GI tract (colon and rectum). Causes of GI bleeding include gastric ulcers, artery or vein (arteriovenous) 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 is an aerosolized spray that delivers a mineral blend to the bleeding site. The device 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, which is bleeding that comes from enlarged veins that develop in certain medical conditions like 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 including an additional 522 patients. The Hemospray device stopped GI bleeding in 95 percent 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 percent of these patients. One serious side effect, bowel perforation, was observed in approximately 1 percent of patients. Hemospray is contraindicated in patients who have a gastrointestinal fistula or are at high risk for experiencing a gastrointestinal perforation.
The FDA reviewed the Hemospray device through the De Novo premarket review pathway, a regulatory pathway for some low to moderate risk devices of a new type.
The FDA permitted marketing of the Hemospray device to Wilson-Cook Medical Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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SOURCE U.S. Food and Drug Administration