Gastrointestinal Bleeding Spray Gets FDA Marketing Go-Ahead

The US Food and Drug Administration has permitted the marketing of Hemospray, a device designed to control forms of bleeding in the gastrointestinal (GI) tract.

The device, an aerosolized spray that administers a mineral blend to the site of bleeding via an endoscopic procedure, is capable of covering large ulcers or even tumors.

Hemospray, from Wilson-Cook Medical, was reviewed by the FDA through the De Novo premarket review pathway, a regulatory practice for new devices with low to moderate clinical risk.

GI bleeding can occur from the upper tract of the esophagus, stomach or small intestine, to the lower tract of the colon or rectum. It is brought on by gastric ulcers, arteriovenous malformations, diverticulosis, cancer, or inflammatory bowel disease. According to Wilson-Cook, Hemospray represents a different approach to treat GI bleeds by reaching hemostasis in patients without the precision or direct visualization required by competing treatments. This makes the device a treatment option for bleeding from damaged tissue where the bleeding source cannot be easily identified.

Hemospray is intended to treat most forms of upper or lower GI bleeding, and is backed by clinical evidence in more than 700 patients.

Its approval was supported by data from clinical studies that consisted of 228 patients with upper and lower GI bleeding, and real-world evidence from medical literature reports that featured another 522 similar patients. According to FDA review, the device stopped GI bleeding in 95% of patients with 5 minutes of its administration. Re-bleeding, as defined by a recurring event from 3-30 days after the use of Hemospray, occurred in 20% of all patients.

Bowel perforation was the lone serious side effect reported in clinical analysis, having been observed in approximately 1% of patients. Hemospray is contraindicated in patients with GI fistula or at significant risk of experiencing GI perforation.

Hemospray is contraindicated in patients who have a gastrointestinal fistula or are at high risk for experiencing a gastrointestinal perforation. It’s not intended for use in patients with variceal bleeding, which develops from medical conditions such as alcoholic liver disease.

Barry Slowey, president of Cook Winston-Salem and vice president of Cook Medical’s Endoscopy specialty, expressed satisfaction for the marketing approval.

“We have worked diligently to bring a different approach to hemostasis for gastroenterology teams across the United States,” Slowey said in a statement.