The U.S. Food and Drug Administration (FDA) has authorized the marketing of a new device called Hemospray which is used for the treatment of certain types of gastrointestinal bleeding. The FDA permitted marketing of the Hemospray device to the medical device company Wilson-Cook Medical Inc.
Gastrointestinal bleeding is all types of bleeding that occurs in gastrointestinal (GI) tract including the esophagus, stomach or small intestine (upper GI tract) or colon and rectum (lower GI tract). Its causes include artery or vein (arteriovenous) malformations, gastric ulcers, cancer or inflammatory bowel disease, and diverticulosis. In older patients, there is a higher risk of death from GI bleeding.
The Hemospray device is intended to treat most types of upper or lower GI bleeding and can cover large ulcers or tumors. The device is an aerosolized spray that delivers a mineral blend to the bleeding site through an endoscopic procedure. When the mineral blend comes in contact with the blood, it absorbs water and forms a gel that covers the bleeding site. It is not intended for use in patients with variceal bleeding, bleeding that comes from enlarged veins that develop in certain medical conditions like alcoholic liver disease. It is a nonthermal, nontraumatic treatment modality for achieving hemostasis.
“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.
For the purpose, 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.
Based on the review the FDA made following inferences:
- the device stopped GI bleeding in 95 percent of patients within five minutes of its 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 are at high risk for experiencing a gastrointestinal perforation
The Hemospray device was reviewed by FDA through the De Novo premarket review pathway, a regulatory pathway for some low to moderate risk devices of a new type.
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.”