WASHINGTON -- An endoscopically delivered is now approved for marketing, the FDA said Monday.
Called and to be sold by Cook Medical, the product is an aerosolized mineral blend that can cover large areas, according to the FDA's announcement.
Data submitted to the agency, from clinical trials and "real-world" evidence in published journal reports, indicated that the product stopped bleeding in 95% of patients within 5 minutes. Recurrent bleeding was seen in 20%, mostly within the first 72 hours, the FDA said. Hemospray has been available in Canada and a number of other markets worldwide for several years.
Bowel perforation -- a risk with any lower GI endoscopic procedure -- was seen in 1%. The FDA noted that the product is not indicated for variceal bleeding, and is contraindicated in patients with GI fistulas or at high risk for GI perforations.