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FDA approves Hemospray device to treat GI bleeding
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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.
Perspective
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John R. Saltzman, MD, FACP, FACG, FASGE, AGAF
Although hemostatic sprays have been available since 2011 in Canada, Europe and other areas of the world, endoscopists in the United States have not had this therapeutic option available until approved by the FDA this week. Hemostatic sprays contain an inorganic powder that coats the surface leading to desiccation of fluid and a procoagulant effect. When delivered by a catheter through the endoscope, the application of this hemostatic spray stops active bleeding with immediate cessation of spurting and oozing bleeding in 95% of patients. This is an extremely important addition to our armamentarium of methods to endoscopically control GI bleeding.
Hemostatic sprays have the advantage of being able to be quickly applied to a bleeding site without special endoscopic expertise or training. The spray can quickly stop massive bleeding from major vessels including the gastroduodenal artery, the left gastric artery, Dieulafoy lesions and peptic ulcers. It also can stop bleeding in difficult locations and challenging conditions including from malignancies. Hemostatic sprays are only effective at stopping actively bleeding lesions and will not be effective at preventing bleeding with visible vessels.
In the United States, hemostatic spray will be utilized in a variety of conditions and situations. In patients with failed hemostasis utilizing current therapies, hemostatic sprays can be employed. In vessels that are too large for conventional endoscopic methods, hemostatic spray can be effective. In bleeding malignancies involving the GI tract, where currently there are no effective therapies, there is emerging evidence that hemostatic sprays can be effective. In rural areas or areas of the country without high level endoscopic expertise available, hemostatic sprays can be employed by physicians with basic endoscopy skills allowing stabilization of the patient and transfer to a more expert center. There is emerging data on the efficacy of hemostatic sprays in patients with variceal bleeding as well as lower GI bleeding.
Physicians need to be aware that there are some caveats to the use of hemostatic sprays. After hemostatic spray application, there is a coating of the GI tract from the powder that obscures endoscopic visualization and additional immediate therapy. In addition, although highly effective at stopping bleeding, hemostatic sprays do not provide durable control of bleeding from a high-risk lesion. Thus, a second endoscopy must be performed to provide therapy to prevent further bleeding, such as with hemoclips.
The availability of endoscopically delivered hemostatic sprays represents a major advance to physicians caring for patients with GI bleeding in the United States and certainly will lead to better outcomes including a lower mortality.
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