The FDA has permitted marketing of the Hemospray device to treat most types of upper or lower GI bleeding, the agency announced on May 7. The aerosolized spray, which delivers a mineral blend to the bleeding site, is applied during an endoscopic procedure and can cover large areas, such as ulcers or tumors.
In clinical studies of 228 patients and medical literature reports that included 522 patients, the device stopped GI bleeding in 95% of patients within five minutes of use. About 20% of patients experienced re-bleeding, usually within 72 hours but up to 30 days after device usage.
About 1% of patients had one serious side effect, bowel perforation. The device is contraindicated in patients with gastrointestinal fistulas and those at high risk for experiencing a gastrointestinal perforation. It is not intended to be used in patients with variceal bleeding.