FDA
permits marketing of new endoscopic device for treating gastrointestinal
bleeding
Today(
“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 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 (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.
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