The Food and Drug Administration has given the green light to Cook Medical to market Hemospray, an aerosolized spray intended to control certain types of bleeding in the gastrointestinal (GI) tract.
Hemospray is applied during endoscopic procedures; the product is a single-use device that delivers hemostatic powder through the channel of an endoscope. Once the powder comes in contact with blood, it forms a gel which creates a mechanical barrier that covers the bleeding site.
The approval was based on the FDA’s review of clinical studies involving 228 patients with upper and lower GI bleeding; this was supplemented with real world evidence from medical literature which included an additional 522 patients.
The studies showed that the device stopped GI bleeding in 95% of individuals within 5 minutes of the spray being used; rebleeding was noted in 20% of patients, usually within 72 hours but up to 30 days after the device was used. Bowel perforation, a potentially serious adverse event, was observed in approximately 1% of patients.
The spray is intended to treat non-variceal GI bleeds but is contraindicated in patients who have a gastrointestinal fistula or are at high risk for experiencing a perforation.
“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, MD, of the FDA’s Center for Devices and Radiological Health.
For more information visit cookmedical.com.