WASHINGTON, May 7 (Xinhua) -- The U.S. Food and Drug Administration (FDA) permitted Monday the marketing of a new device used to help control certain types of bleeding in the gastrointestinal (GI) tract.
"The device provides an additional, non-surgical 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, director of division of surgical devices in the FDA's Center for Devices and Radiological Health.
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 malformations, diverticulosis, cancer or inflammatory bowel disease. Older patients are at a higher risk of death from severe GI bleeding.
The device called Hemospray, an aerosolized spray that delivers a mineral blend to the bleeding site, is intended to treat most types of upper or lower GI bleeding.
The device is applied during an endoscopic procedure and can cover large areas such as large ulcers or tumors, according to FDA.
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. The 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.
Hemospray is contraindicated in patients who have a gastrointestinal fistula or are at high risk for experiencing a gastrointestinal perforation.
