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FDA approves Cook Medical’s endoscopic device to treat gastrointestinal bleeds

MDBR Staff Writer Published 08 May 2018

Cook Medical has secured approval from the US Food and Drug Administration (FDA) for Hemospray, an endoscopic hemostat to treat gastrointestinal (GI) bleeds.

The firm will market the new endoscopic device to clinicians across the US for the treatment of non-variceal GI bleeds.

Hemospray is a single-use device, which delivers hemostatic powder through the channel of an endoscope toward the source of a bleed.

Cook Medical endoscopy speciality vice president and Cook Winston-Salem president Barry Slowey 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.”

GI bleeding may occur in the upper GI tract such as esophagus, stomach or small intestine, as well as the lower GI tract such as colon and rectum. GI bleeding results in gastric ulcers, artery or vein (arteriovenous) malformations, diverticulosis, cancer or inflammatory bowel disease.

The device, which is applied during an endoscopic procedure, holds capacity to cover large areas such as large ulcers or tumors.

When the powder reaches blood, the device absorbs water and forms a gel, which acts cohesively and adhesively to form a stable mechanical barrier that covers the bleeding site.

According to the company, Hemospray is a nonthermal is a nonthermal and nontraumatic treatment modality for achieving hemostasis.

Since 2011, Cook Medical’s Hemospray has been using for the treatment of bleeding in the GI tract. It is used to treat thousands of patients in Europe, Canada and other countries acoss the globe.

FDA's Center for Devices and Radiological Health surgical devices division director Dr Binita Ashar 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.”

Image: Cook Medical’s Hemospray endoscopic hemostat. Photo: courtesy of Cook.