FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding

The U.S. Food and Drug Administration permitted marketing of Hemospray, a new device used to help control certain types of bleeding in the gastrointestinal (GI) tract.

“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,” said Binita Ashar, M.D., director, division of surgical devices, in the FDA’s Center for Devices and Radiological Health.

GI bleeding can occur in the upper GI tract (esophagus, stomach or small intestine) or the lower GI tract (colon and rectum). Causes of GI bleeding include gastric ulcers, artery or vein (arteriovenous) malformations, diverticulosis, cancer or inflammatory bowel disease. Older patients are at a higher risk of death from severe GI bleeding.  

The Hemospray device is intended to treat most types of upper or lower GI bleeding. The device is an aerosolized spray that delivers a mineral blend to the bleeding site. The device is applied during an endoscopic procedure and can cover large areas such as large ulcers or tumors. The device is not intended for use in patients with variceal bleeding, which is bleeding that comes from enlarged veins that develop in certain medical conditions like alcoholic liver disease.

The FDA reviewed data from clinical studies consisting of 228 patients with upper and lower GI bleeding, supplemented with real world evidence from medical literature reports including an additional 522 patients. The Hemospray device stopped GI bleeding in 95 percent of patients within five minutes of device usage. Re-bleeding, usually within 72 hours, but up to 30 days following device usage, was observed in 20 percent of these patients. One serious side effect, bowel perforation, was observed in approximately 1 percent of patients. Hemospray is contraindicated in patients who have a gastrointestinal fistula or are at high risk for experiencing a gastrointestinal perforation.
The FDA permitted marketing of the Hemospray device to Wilson-Cook Medical Inc.

Early Clinical Evidence Demonstrates Incisionless Procedure Stops Life-Threatening Bleeding From Stomach Ulcers

According to early clinical evidence from a safety study, a new endoscopic spray from Cook Medical may offer a new surgery-free procedure for treating potentially fatal acute bleeding of peptic ulcers. The early results, collected at the Chinese University of Hong Kong by lead investigators Dr. Joseph Sung of the Chinese University and Dr. Sam Giday of Johns Hopkins University, suggest an alternative to currently available endoscopic and surgical intervention for major gastrointestinal (GI) bleeds.

"Peptic ulcer bleeds are medical emergencies that require swift action and the most effective treatment possible," said Dr. Giday. "This hemostatic spray shows promise for a faster, easier and less invasive procedure than currently available treatment modalities, which requires expert precision and a certain degree of endoscopic expertise."

The hemospray, a proprietary powder with unique clotting abilities, can be sprayed directly onto a bleeding peptic ulcer through the channel of an endoscope, a hollow tube with a camera attached that is guided down a patient's throat and into the stomach. In the safety study to date, the spray has been delivered to ten patients with acute GI bleeding. Patient bleeding was controlled in nine of 10 patients observed in the study, and after 72 hours eight patients were released with no apparent signs of rebleeding. A total of 20 patients will be enrolled in this initial study, the results of which will be used to decide whether further clinical trials will be conducted. The investigators expect to release final results of the study at the 2010 Digestive Disease Week conference in New Orleans in May.

"These results suggest that this hemostatic spray could be an important innovation in helping to control this dangerous complication of peptic ulcers," said Barry Slowey, global business unit leader for Cook Medical's Endoscopy strategic business unit. "The safety study to-date has demonstrated that the spray has the potential to improve the care of patients suffering from peptic ulcers while greatly simplifying the treatment procedure."

Between 4 to 5 million1 people are treated annually around the globe for GI bleeds, with the most difficult to treat being peptic ulcers: open sores in the lining of the stomach, esophagus or duodenum. Peptic ulcer bleeding typically afflicts individuals over the age of 60 and causes death in approximately eight percent of cases. Current treatment involves using dual endoscopic modalities such as clips, injection and thermoelectric probes. If proven safe and effective in ongoing clinical studies, this will be the first hemostatic spray to offer a viable alternative to the current endoscopic and surgical treatment modalities.

In a previous controlled animal trial on induced arterial bleeds in heparinized animals, the spray stopped 100 percent of bleeding with no recurrent bleeds observed during a seven-day follow up [Giday et al. DDW 2009]. Digestive Disease Week ranked the summary of this animal model study as one of its top abstracts of 2009, signaling its importance to endoscopic physicians. Dr. Giday is a paid consultant of Cook Medical in the development of the hemospray project.