The FDA has granted pre-market approval to a new device used used to help control certain types of bleeding in the gastrointestinal (GI) tract.
FDA Approval
Developed by Cook Medical, the Hemospray device is am aerosolised spray that delivers a mineral blend to help treat most types of upper and lower GI bleeding. The device is applied during an endoscopic procedure and can cover large areas such as large ulcers or tumours.
The FDA reviewed data from clinical studies consisting of 228 patients with upper and lower GI bleeding, supported by real world evidence from medical reports including an additional 522 patients. The device was found to stop bleeding in 95% of patients within five minutes. Re-bleeding occurred in 20% of patients within 30 days, and a serious side effect of bowel perforation was observed in 1% of patients.
Barry Slowey, president of Cook Winston-Salem and vice president of Cook Medical’s Endoscopy speciality, said: “We are extremely pleased to receive this approval to market from FDA. We have worked diligently to bring a different approach to hemostasis for gastroenterology teams across the United States.”
The Hemospray device is a single-use device that delivers hemostatic powder through the channel of an endoscope toward the source of a bleed. When the powder comes in contact with blood, it absorbs water and forms an gel, which creates a barrier that covers the bleeding site.
Current endoscopic hemostasis treatments can carry further risk of tissue damage and require precise placement directly onto the bleeding vessel.
Binita Ashar, director, division of surgical devices, in the FDA’s Center for Devices and Radiological Health, said: “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.”