The US Food and Drug Administration (FDA) today permitted marketing of Hemospray, a new device that aims to control certain types of gastrointestinal (GI) bleeding, according to an FDA news release.
The proprietary aerosolized mineral-blend spray, applied during an endoscopic procedure, "absorbs water and forms a gel, which acts cohesively and adhesively to create a stable mechanical barrier that covers the bleeding site," according to a news release from the manufacturer, Wilson-Cook Medical. It is intended for most types of upper- or lower-GI bleeds and can cover large ulcers or tumors.
The spray gives physicians an added nonsurgical option "and may help reduce the risk of death from a GI bleed for many patients," Binita Ashar, MD, director of surgical devices in the FDA's Center for Devices and Radiological Health, said in the release. Older patients are at a higher risk for death from severe GI bleeding.
It is not intended for variceal bleeding, which can develop with certain conditions, such as alcoholic liver disease. It should not be used in patients who have a GI fistula or are at high risk for a GI perforation.
Permission to market was granted to Wilson-Cook Medical after the spray was reviewed through the de novo market pathway available to some low- to moderate-risk devices.
The FDA reviewed clinical studies with 228 patients who had upper and lower GI bleeding, as well as evidence from literature that included an additional 522 patients. Hemospray stopped GI bleeding in 95% of patients within 5 minutes. Investigators checked for rebleeding up to 30 days after use and it was found it in 20% of the patients, but usually within 72 hours. Bowel perforation was observed in 1% of patients studied.
According to information from Wilson-Cook Medical, Hemospray "contains no human or animal proteins or botanicals and has no known allergens. Hemospray is metabolically inert and deemed nontoxic, systemically or otherwise."
Similar materials have been used by the military for years for topical battlefield hemostasis, the company says.
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Cite this: FDA OKs Marketing of Endoscopic Hemospray for Most GI Bleeds - Medscape - May 07, 2018.