Here are five things to know.
1. The FDA permitted Wilson-Cook Medical to market the device.
2. The Hemospray device is an aerosolized spray that delivers a mineral blend to the bleeding site. It is used during an endoscopic procedure and is designed to cover large areas such as ulcers or tumors.
3. The device is intended to treat most types of upper or lower GI bleeding. It is not intended for use in patients with variceal bleeding.
4. The device is contraindicated in patients who have a gastrointestinal fistula or are at a high risk of gastrointestinal perforation.
5. The FDA reviewed the Hemospray device through the de novo premarket review pathway for novel low-to-moderate risk devices.
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