The FDA granted premarket approval to Cook Medical’s Hemospray, an aerosol to help control most types of bleeding within the upper and lower gastrointestinal tract, including those caused by gastric ulcers, cancer, malformed blood vessels, diverticulosis or inflammatory bowel disease.
The mineral spray can be delivered to a wide area through an endoscope, covering large ulcers, tumors or diffuse and hard-to-visualize bleeds. An inorganic powder then absorbs water in the blood and adheres to the site, forming a gel barrier to stop the bleeding.
The agency said the single-use device achieved hemostasis in 95% of patients within five minutes in clinical studies, with subsequent rebleeding—usually within 72 hours, but up to 30 days after use—seen in 20% of patients.
Compared to thermal or mechanical hemostats requiring physical contact, which can also risk further tissue damage, nonsurgical Hemospray does not require precise or direct visualization of the bleed, Cook Medical said.
GI bleeds are a leading cause of death in the U.S., responsible for an estimated 20,000 per year. Hemospray has been available in Europe, Canada and other countries since 2011, and the company plans to make it available to U.S. clinicians soon.
The FDA analyzed data from 228 patients with upper and lower GI bleeding through its de novo review process—and incorporated real-world evidence from medical literature covering an additional 522 patients, including summary data from at least 19 studies.
Hemospray is contraindicated in patients at high risk for gastrointestinal perforations or with a fistula. In clinical studies, bowel perforations were observed in approximately 1% of patients. The spray is also not intended for use in patients with variceal bleeding, such as from the enlarged veins related to alcoholic liver disease.