FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding

The U.S. Food and Drug Administration permitted marketing of Hemospray, 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, M.D., director, division of surgical devices, in the FDA’s Center for Devices and R adiological 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 (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 a...
Source: Medical Hemostat - Category: Medical Devices Authors: Source Type: blogs