Cook Medical said yesterday it won FDA de novo clearance for its Hemospray endoscopic hemostat designed for treating bleeding in the gastrointestinal tract.
The Hemospray product won indications from the FDA for treating non-variceal GI bleeds, the Bloomington, Ind.-based company said. Hemospray is a single-use device designed to deliver an aerosolized spray of a mineral blend to a bleeding site during endoscopic procedures, and can cover large areas including ulcers and tumors, according to an FDA release.
“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,” Cook Medical endoscopy VP Barry Slowey said in a prepared release.
“Hemospray gives clinicians another tool for the care of their patients. Patients have been our number one priority for over 50 years and we’ve worked hard to bring this innovation to the field of gastroenterology across the U.S.,” Cook Medical MedSurg VP DJ Sirota said in prepared remarks.
The Hemospray powder is intended to absorb the water in blood to form a gel which acts both cohesively and adhesively to create a barrier to the bleeding site, Cook Medical said.
In its approval, the FDA said it reviewed data from studies of 228 patients with upper and lower GI bleeding alongside real-world evidence from medical literature reports which included data on an additional 522 patients. The Hemospray device was found to have stopped GI bleeding in 95% of patietns within 5 minutes of device usage.
The FDA said that 20% of patients experienced rebleeding between 72 hours and 30 days, and bowel perforations were observed in 1% of patients.
“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,” FDA Center for Devices and Radiological Health surgical devices division director Dr. Binita Ashar said in a press release.
Early last month, Cook Medical said it re-launched its Beacon Tip Torcon NB advantage catheters in the US and Canada, after having recalled the devices due to complaints related to device tips on the items degrading and fracturing.