The FDA granted Wilson-Cook Medical marketing clearance for its Hemospray device used to control bleeding in the gastrointestinal tract.
The agency reviewed the device through the De Novo premarket review pathway for low to moderate risk devices of a new type.
The device is an aerosolized spray that delivers a mineral blend to the bleeding site. It is used during an endoscopic procedure and can cover large areas such as large ulcers or tumors.
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. The Hemospray device stopped GI bleeding in 95 percent of patients within five minutes.