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The Food and Drug Administration announced May 7 that it has permitted marketing of .
Hemospray is an aerosolized spray device that delivers a mineral blend to the bleeding site in the GI tract and is applied during endoscopic procedures and can cover large ulcers or tumors.
The FDA evaluated data from clinical studies consisting of 228 patients with upper and lower GI bleeding, supplemented with evidence from medical literature, including an additional 522 patients. The studies found that Hemospray stopped GI bleeding in 95% of patients within 5 minutes of device usage. Results also found that bleeding recurred, usually within 72 hours, and up to 30 days following device usage, in 20% of patients. Bowel perforation was observed as a serious side effect in approximately 1% of patients.
“The device provides an additional, nonsurgical 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, MD, director, division of surgical devices, in the FDA’s Center for Devices and Radiological Health in a press release.
Hemospray is not intended for patients who have a gastrointestinal fistula or are at high risk for GI perforation. The device is not intended for use in patients with variceal bleeding. The FDA permitted the marketing of the Hemospray device to Wilson-Cook Medical.*
Read the full press release here.
Correction, 5/10/18: An earlier version of this article incorrectly described the patient population that should not be treated with Hemospray.
The Food and Drug Administration announced May 7 that it has permitted marketing of .
Hemospray is an aerosolized spray device that delivers a mineral blend to the bleeding site in the GI tract and is applied during endoscopic procedures and can cover large ulcers or tumors.
The FDA evaluated data from clinical studies consisting of 228 patients with upper and lower GI bleeding, supplemented with evidence from medical literature, including an additional 522 patients. The studies found that Hemospray stopped GI bleeding in 95% of patients within 5 minutes of device usage. Results also found that bleeding recurred, usually within 72 hours, and up to 30 days following device usage, in 20% of patients. Bowel perforation was observed as a serious side effect in approximately 1% of patients.
“The device provides an additional, nonsurgical 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, MD, director, division of surgical devices, in the FDA’s Center for Devices and Radiological Health in a press release.
Hemospray is not intended for patients who have a gastrointestinal fistula or are at high risk for GI perforation. The device is not intended for use in patients with variceal bleeding. The FDA permitted the marketing of the Hemospray device to Wilson-Cook Medical.*
Read the full press release here.
Correction, 5/10/18: An earlier version of this article incorrectly described the patient population that should not be treated with Hemospray.
The Food and Drug Administration announced May 7 that it has permitted marketing of .
Hemospray is an aerosolized spray device that delivers a mineral blend to the bleeding site in the GI tract and is applied during endoscopic procedures and can cover large ulcers or tumors.
The FDA evaluated data from clinical studies consisting of 228 patients with upper and lower GI bleeding, supplemented with evidence from medical literature, including an additional 522 patients. The studies found that Hemospray stopped GI bleeding in 95% of patients within 5 minutes of device usage. Results also found that bleeding recurred, usually within 72 hours, and up to 30 days following device usage, in 20% of patients. Bowel perforation was observed as a serious side effect in approximately 1% of patients.
“The device provides an additional, nonsurgical 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, MD, director, division of surgical devices, in the FDA’s Center for Devices and Radiological Health in a press release.
Hemospray is not intended for patients who have a gastrointestinal fistula or are at high risk for GI perforation. The device is not intended for use in patients with variceal bleeding. The FDA permitted the marketing of the Hemospray device to Wilson-Cook Medical.*
Read the full press release here.
Correction, 5/10/18: An earlier version of this article incorrectly described the patient population that should not be treated with Hemospray.