Health Problem: Gastrointestinal (GI) bleeding is a serious, often life-threatening, condition. There are many potential sources of GI bleeding, including an underlying condition with ulcerative and nonulcerative lesions, malignancy, or as a result of medical interventions. Vascular malformations may underlie GI bleeding as well. Estimates of acute upper GI bleeding range from 15 to 570 per 100,000 people, with wide variability depending on bleeding etiology and age. Bleeding incidence increases dramatically with age. Mortality due to upper GI hemorrhage is roughly 2%.
Technology Description: Hemospray is an inorganic mineral-based powder that is deployed near a bleeding site using pressurized carbon dioxide. Hemospray becomes cohesive when it makes contact with moisture or blood, creating a tamponade over the bleeding site and rapidly achieving hemostasis. Since it generally does not attach to nonbleeding surfaces, Hemospray only impacts areas of active bleeding and is neither taken up nor broken down by the mucosa.
Controversy: Patients that present with symptoms of upper GI bleeding require immediate effective intervention. Hemospray may provide an additional treatment option for these patients. Hemospray shows a good safety profile and is eliminated from the GI tract after 70 hours. There is a theoretical risk of intestinal perforation, embolization, and intestinal obstruction, but these have not been definitively linked to the use of hemostatic agents. Additionally, devices that use pressurized gas for delivery of hemostatic agents may interfere with endoscopic visualization.
Key Questions:
- Does Hemospray effectively establish hemostasis and reduce rates of rebleeding for upper GI bleeding?
- How does Hemospray compare with conventional hemostasis interventions?
- Is Hemospray safe?
- Have definitive patient selection criteria been identified for Hemospray?
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