Summary of Clinical Data:
Clinical data summary information that was, in part, the basis for granting the de novo can be found on the Cook Medical website at CookMedical.com/HemosprayData
Alzoubaidi D, Hussein M, Rusu R, et al. Outcomes from an international multicenter registry of patients with acute gastrointestinal bleeding undergoing endoscopic treatment with Hemospray. Digestive Endoscopy. E-Published 2019.
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Mourad FH, Leong RW. Role of hemostatic powders in the management of lower gastrointestinal bleeding: A review. Journal of Gastroenterology and Hepatology. E-published 22 March 2018.
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Haddara S, Jacques J, Lecleire S, et al. A Novel Hemostatic Powder for Upper Gastrointestinal Bleeding: A Multicenter Study (the “GRAPHE” registry). 2016 Dec; 48(12): 1084-1095.
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Chen Y, Barkun A. Hemostatic Powders in Gastrointestinal Bleeding: A Systematic Review. Gastrointestinal Endoscopy Clinics of North America. 2015 July; 25(3): 535-552.
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Changela K, Papfragkakis H, Ofori E, et al. Hemostatic powder spray: a new method for managing gastrointestinal bleeding. Therapeutic Advances in Gastroenterology. 2015 May;8(3):125-35.
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Szalai M, Kullmann T, Durcsán H, et al. Hemospray: a novel therapeutic option in the management of acute upper gastrointestinal bleeding. Orvosi Hetilap. 2015 Mar;156(13):528-31.
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Appleby VJ, Hutchinson JM, Beckett CJ, Moreea S. Use of the haemostatic agent TC-325 in the treatment of bleeding secondary to endoscopic retrograde cholangiopancreatography sphincterotomy. QJM. 2015 Jan;108(1):79-80.
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Parsi MA, Jang S. Hemospray for diffuse anastomotic bleeding. Gastrointestinal Endoscopy. 2014 Dec; 80(6):1170.
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Selvapatt N., Hoare J. A novel method of achieving haemostasis in transfusion-dependent small bowel malignancy-related bleeding. BMJ Case Reports. E-published 16 December 2014.
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Zimmer, V., Lammert F. Retrograde transpyloric hemostatic powder intervention of a concealed prepyloric antral ulcer. Gastrointestinal Endoscopy, 2014 Dec; 80(6): 1207.
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Masci E, Arena M, Morandi E, et al. Upper gastrointestinal active bleeding ulcers: review of literature on the results of endoscopic techniques and our experience with Hemospray. Scandinavian Journal of Gastroenterology. 2014 Nov;49(11):1290-5.
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Bustamante-Balén M, Plumé G.World J. Role of hemostatic powders in the endoscopic management of gastrointestinal bleeding. Gastrointest Pathophysiol. 2014 Aug 15;5(3):284-92.
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Sulz MC, Frei R, Meyenberger C, Bauerfeind P, Semadeni GM, Gubler C. Routine use of Hemospray for gastrointestinal bleeding: prospective two-center experience in Switzerland. Endoscopy. 2014 Jul;46(7):619-24.
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Iacucci M. Hemostatic spray- a welcome addition to the armamentarium against gastrointestinal bleeding. Canadian Journal of Gastroenterology and Hepatology. 2014 Feb; 28(2): 71.
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Yau A, Ou G, Galoport C, et al. Safety and efficacy of Hemospray in upper gastrointestinal bleeding. Canadian Journal of Gastroenterology and Hepatology. 2014 Feb; 28(2): 72-76.
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Holster IL, Brullet E, Kuipers EJ, et al. Hemospray treatment is effective for lower gastrointestinal bleeding. Endoscopy. 2014 Jan; 46(1): 75-78.
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Dietrich, C., Hochdӧrffer, R., et al. Successful use of Hemospray to control refractory duodenal diverticular bleeding. Endoscopy. 2014. 46(S01): E605-E606.
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Kratt T, LangeJ, Königsrainer A, et al. Successful Hemospray treatment for recurrent diclofenac-induced severe diffuse lower gastrointestinal bleeding avoiding the need for colectomy. Endoscopy 2014; 46(S 01): E173-E174.
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Tarantino, Barresi, Granata, et al. Hemospray for arterial hemorrhage following endoscopic ultrasound -guided pseudocyst drainage. Endoscopy. 2014;46(S 01):E71.
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Morris AJ, Smith LA, Stanley A, et al. Hemospray for non-variceal upper gastrointestinal bleeding: Results of the Seal Dataset (survey to evaluate the application of Hemospray in the luminal tract). Journal of Clinical Gastroenterology. E-published December 2013.
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Granata, Curcio, Azzopardi, Barresi, Tarantino, Traina. Hemostatic powder as rescue therapy in a patient with H1N1 influenza with uncontrolled colon bleeding. Gastrointestinal Endoscopy. 2013 Sept: 78(3): 451.
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Leblanc S, Vienne A, Dhooge M, et al. Early experience with a novel hemostatic powder used to treat upper GI bleeding related to malignancies or after therapeutic interventions. Gastrointestinal Endoscopy. 2013 July; 78(1):169-74.
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Babiuc RD, Purcarea M, Sadagurschi R, Negreanu L. Use of Hemospray in the treatment of patients with acute UGIB – short review. Journal of Medicine and Life. 2013 Jun; 6(2):117-119.
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Moosavi S, Chen YI, Barkun AN. Topical hemostatic agents: a systematic review with particular emphasis on endoscopic application in GI bleeding. Gastrointestinal Endoscopy. 2013 May; 77(5):692-700.
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Soulellis CA, Carpentier S, Chen YA, et al. Lower GI hemorrhage controlled with endoscopically applied TC-325. Gastrointestinal Endoscopy. 2013 Mar;77(3):504-507.
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Holster IL, Kuipers EJ, Tjwa ET. Hemospray in the treatment of upper gastrointestinal hemorrhage in patients on antithrombotic therapy. Endoscopy. 2013 Jan;45(1):63-6.
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Chen YI, Barkun AN, Soulellis C, et al. Use of the endoscopically applied hemostatic powder TC-325 in cancer-related upper GI hemorrhage: preliminary experience. Gastrointestinal Endoscopy. 2012 Jun;75(6):1278-81.
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Sung JJ, Luo D, Wu JC, et al. Early clinical experience of the safety and effectiveness in achieving hemostasis in patients with acute peptic ulcer bleeding. Endoscopy. 2011 Apr; 43(4):291-5.
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Barkun AN, Adam V, Lu Y, et al. Using Hemospray Improves the Cost-effectiveness Ratio in the Management of Upper Gastrointestinal Nonvariceal Bleeding. Journal of Clinical Gastroenterology. Journal of Clinical Gastroenterology. 2018 Jan; 52(1):36-44.
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Beye B, Barret M, Alatawi A, et al. Topical hemostatic powder promotes reepithelialization and reduces scar formation after extensive esophageal mucosal resection. Diseases of the Esophagus. E-published 5 June 2015.
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Giday SA, Van Alstine WG, Van Vleet JF, et al. Safety analysis of a hemostatic powder in a porcine model of acute severe gastric bleeding. Digestive Disease Sci. 2013 Dec; 58(12):3422-8.
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Giday SA, Kim Y, Krishnamurty DM, et al. Long-term randomized controlled trial of a novel nanopowder hemostatic agent (TC-325) for control of severe arterial upper gastrointestinal bleeding in a porcine model. Endoscopy. 2011 Apr;43(4):296-9.
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