The FDA announced it has approved Hemospray, an endoscopic hemostat used to treat gastrointestinal bleeds.
The device stops GI bleeding without thermal, mechanical or contact methods that can lead to complications caused by other hemostasis treatments, according to a press release.
“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,” Binita Ashar, MD, director of the division of surgical devices in the FDA’s Center for Devices and Radiological Health, said in an FDA news release.
The single-use endoscopic device sprays an inorganic powder on the source of the bleed. When it touches blood, the powder absorbs water and creates a gel that forms a barrier over the bleeding site. This application method can be used without direct visualization of the bleeding site, according to Cook Medical.
The FDA reviewed data from clinical studies that included 228 patients with upper and lower GI bleeding, as well as real world evidence from medical literature reports that included an additional 522 patients. They found the Hemospray device stopped GI bleeding in 95% of patients within five minutes of using the spray. Re-bleeding occurred in 20% of patients, usually within 72 hours, according to the FDA’s release.
Hemospray has been available in Europe, Canada and elsewhere around the world since 2011.
“We are extremely pleased to receive this approval to market from FDA,” Barry Slowey, president of Cook Winston-Salem and vice president of Cook Medical’s endoscopy specialty, said in the press release. “We have worked diligently to bring a different approach to hemostasis for gastroenterology teams across the United States.”
Disclosures: Ashar is employed by the FDA. Slowey is employed by Cook Medical.