
pGlcNAc Fibers Demonstrate Effectiveness in a Variety of Clinical Trials and Applications
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A Poly-N-Acetyl Glucosamine Dressing for Bleeding at Femoral Artery Access Site
SyvekExcel® safely controlled bleeding at arterial access sites and early ambulation, even with nearly immediate sheath removal and systematic anticoagulation using bivalirudin.
Mego D, Thomas M, Stewart J, et al. J Invas Cardiol. 2010; 22:35-39 -
Efficacy and Safety of a Topical, Vascular-Access Hemostasis System in Anticoagulated Patients Undergoing Interventional Cardiac Catheterization
Femoral artery hemostasis and 2-hr ambulation after interventional cardiac catheterization were consistently achieved with the SyvekExcel topical, vascular-access, hemostasis system in anticoagulated patients.
Ghitis A, Cusnir H, Salajka H, et al. Cardiovasc Revasc Med. 2008;9 (2):128. -
Hemostatic Properties of Glucosamine-Based Materials
Different glucosamine polymers can have very different abilities to activate hemostatic systems. Microalgal-derived pGlcNAc was found to be the most effective polymeric material for accelerating fibrin polymerization.
Fischer T, Bode A, Demcheva M, et al. J Biomed Mater Res. 2007; 80A: 167-174. -
Synergistic Platelet Integrin Signaling and Factor XII Activation in Poly-N-acetyl Glucosamine Fiber-Mediated Control of Bleeding
A catalytic surface for thrombin generation and accelerated fibrin clot formation results from the interaction of platelets with pGlcNAc.
Fischer TH, Thatte HS, Nichols TC, et al. Biomaterials. 2005;26: 5433-5443 -
In Vitro Effects of Poly-N-Acetyl Glucosamine on the Activation of Platelets in Platelet-Rich Plasma with and without Red Blood Cells
Poly-N-acetyl glucosamine fiber material affects the clotting of blood by activation of platelets.
Valeri C, Srey R, Tilahun D, et al. J Trauma. 2004; 57:S22-S25 -
Effectiveness and Safety of the Syvek Patch with One Hour of Bedrest After Coronary Angiography Using Six-French Catheters
After 1 hour of supine bedrest, none of the 200 patients experienced a major adverse event with ambulation.
Palmer B, Gantt D, Lawrence M, et al. Am J Cardiol. 2004; 93:96-97 -
Isolation, Purification, and Characterization of Poly-N-Acetyl Glucosamine Used as a Hemostatic Agent
Poly-N-acetyl glucosamine fiber is capable of activating platelets by specific receptor-based interactions leading to rapid expression of vasoconstrictor substances and also resulting in the surface exposure of phosphatidylserine.
Vournakis JN, Demcheva M, Whitson AB, et al. J Trauma. 2004; 57:S2-S6 -
Mechanisms of Poly-N-Acetyl Glucosamine Polymer Mediated Hemostasis: Platelet Interactions
Poly-N-acetyl glucosamine fiber material promotes hemostasis by the activation of platelets.
Thatte H, Zagarins S, Khuri S,et al. J Trauma. 2004;57:S13-S21 -
Evaluation of Poly-N-Acetyl Glucosamine in Patients Undergoing Cardiac Catheterization: A Double-Blind, Randomized Study
The time to effective control of bleeding at the femoral insertion site was decreased in the pGlcNAc group by 37% versus patients receiving the placebo group.
Najjar SF, Healey N, Healey CM, et al. J Trauma. 2004;57:S38-S41 -
Controlling Bleeding in the Era of the Chronic Anticoagulated Patient
Poly-N-acetyl glucosamine (pGlcNAc) helps to control bleeding through mechanisms that involve vasoconstriction, red blood cell agglutination and platelet activation for fibrin clot formation.
Weiner B, Fischer T, Waxman S. J Invas Cardiol. 2003; 15 (11):669-673 -
Harvard Symposium on the Clinical Efficacy and Mechanism of Action of Poly-N-Acetyl Glucosamine
The mechanism of action of the pGlcNAc polymer activates several aspects of the physiological and biochemical cascades, resulting in control of bleeding.
Hirsch JA. Cath Lab Digest. 2003:6:92-95 -
Non-Invasive Closure Devices: "Patches and Pads"
Syvek leads to rapid cessation of bleeding without leaving foreign material at the arterial puncture site or in the tissue tract, thereby reducing the potential for infection and for localized inflammatory tissue responses.
Hirsch JA, Reddy SA, Capasso WE,et al. Tech Vasc Interv Radiol. 2003;6:92-95 -
Modified Rapid Deployment Hemostat Bandage Reduces Blood Loss and Mortality in Coagulopathic Pigs with Severe Liver Injury
Fully acetylated pGlcNAc reduced mortality, total blood loss, and total intravenous fluid requirements, and increased survival time when used as an adjunct to standard abdominal packing after severe liver injury.
Jewelewicz D, Cohn S, Crookes B, et al. J Trauma. 2003;55:275-281 -
Clinical Evaluation of the SyvekPatch® in Consecutive Patients Undergoing Interventional, EPS and Diagnostic Cardiac Catheterization
The use of the SyvekPatch® on a total of 1,000 consecutive patients resulted in the rapid control of bleeding.
Nader R, Garcia J, Drushal K, et al. J Invas Cardiol. 2002; 14:305-307 -
Early Sheath Removal with Angiomax and SyvekPatch
The Miami Heart cath lab completed a study using Angiomax® (bivalirudin) and the SyvekPatch®, testing early sheath removal. Results were excellent, and this protocol has become standard for some clinicians in the cath lab.
Drushal K, Pesek T. Cath Lab Digest. 2002; 10:16-18 -
Vascular Effects of Poly-N-Acetyl Glucosamine in Isolated Rat Aortic Rings
pGlcNAc produced a concentration-dependent vasoconstriction via an endothelium-dependent mechanism, partly via enhancement of endothelin-1 release from endothelial cells.
Ikeda Y, Young L, Vournakis J, et al. J Surg Res. 2002; 102:215-220 -
A Pilot Study Evaluating the Efficacy of a Fully Acetylated Poly-N-acetyl Glucosamine Membrane Formulation as a Topical Hemostatic Agent
The p-GlcNAc membrane required fewer cycles of compression in the swine splenic incision model to control bleeding than either absorbable collagen or oxidized cellulose.
Cole D, Connolly J, Chan M, et al. Surgery. 1999;126: 510-517 -
Control of Post-Dialysis Bleeding in Patients on Chronic Oral Anticoagulation Therapy
Extensive compression following dialysis can result in costly operational inefficiencies, expose patients and staff to bloodborne pathogens, and contribute to vascular access damage. Syvek was found to be a safe and effective method to rapidly control bleeding in hemodialysis patients versus manual compression with gauze or using clamps (n = 50). There were no cases of re-bleeding when using Syvek, and it significantly reduced compression time for hypertensive patients and patients taking concomitant anticoagulation.
Meyer K, Jenuleson C, Vital A, et al. Amer Soc Nephrol. 1999. Meeting Abstract
- Successful treatment of two refractory venous stasis ulcers treated with a novel poly-N-acetyl glucosamine-derived membrane Maus, EA. BMJ Case Reports 2012; doi:10.1136/bcr.03.2012.6091
- Clinical and cost efficacy of advanced wound care matrices for venous ulcers Hankin CS, Knispel J, Lopes M, Bronstone A, Maus E. J Manag Care Pharm. 2012 Jun;18(5):375-84
- A Randomized, Investigator-Blinded, Controlled Pilot Study to Evaluate the Safety and Efficacy of a Poly-N-Acetyl Glucosamine–Derived Membrane Material in Patients with Venous Leg Ulcers Kelechi T, Mueller M, Hankin C, et al. J Am Acad Dermatol, 2011 May 25
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mrdh Bandage for Surgery and Trauma: Data Summary and Comparative Review
The mrdh bandage stops both venous and arterial bleeding, even in the presence of a coagulopathy.
Valeri C, Vournakis J. J Trauma. 2011;71:S162–S166 -
A Modified Rapid Deployment Hemostat Bandage: Surgeon Experience at Level 1 Trauma Centers
A prospective study of trauma patients suffering serious hemorrhage at 10 Level 1 trauma centers in the United States and at one U.S. Combat Support Hospital in Iraq.
King D, Cohn S, Schreiber M, et al. Gen Surg News. 2010 Feb; 37:02 -
Control of Troublesome Bleeding During Repair of Acute Type A Dissection with Use of Modified Rapid Deployment Hemostat (MRDH)
In an ascending aorta graft, being performed on a patient with acute type A dissection, attempts at suturing and other maneuvers failed to control hemorrhage. Modified rapid deployment hemostat (MRDH) was successful in controlling hemorrhage. It is a novel hemostatic agent with invaluable use in troublesome bleeding occurring during heart surgery.
Salerno T, Gaughan C, Suarez M, et al. J Card Surg. 2009; 24:722-724 -
Hemostatic Properties of Glucosamine-Based Materials
Comparison of the properties of the poly-N-acetyl glucosamine fiber-derived materials with chitin, chitosan, and commercial chitosan-based products are presented. The results demonstrate that hemostatic responses to the glucosamine-based materials studied are highly dependent on their chemical nature and tertiary/quaternary structure. The unique natural microalgal fibers were found to have strongly prohemostatic activity compared to the other materials studied.
Fischer T, Bode A, Demcheva M, et al. J Biomed Mater Res. 2007; 80A: 167–174 -
Synergistic Platelet Integrin Signaling and Factor XII Activation in Poly-N-acetyl Glucosamine Fiber-Mediated Control of Bleeding
A catalytic surface for thrombin generation and accelerated fibrin clot formation results from the interaction of platelets with pGlcNAc.
Fischer TH, Thatte HS, Nichols TC, et al. Biomaterials. 2005;26: 5433-5443 -
Modified Rapid Deployment Hemostat Bandage Terminates Bleeding in Coagulopathic Patients with Severe Visceral Injuries.
More than 80% of all early civilian trauma deaths are due to uncontrolled hemorrhage, and half of these are from severe liver injuries.1 Blunt high-grade hepatic injuries requiring operative intervention have a mortality rate from 50 to 100%.2–4 Several hemostatic devices and dressings are being developed to aid in controlling bleeding from these deadly injuries.5
King D, Cohn S, Proctor K, et al. J Trauma. 2004 Oct; 57:756-759 -
Modified Rapid Deployment Hemostat Bandage Reduces Blood Loss and Mortality in Coagulopathic Pigs with Severe Liver Injury
Hemostasis can be difficult to achieve after blunt abdominal trauma, particularly if the patient is coagulopathic. The U.S. Food and Drug Administration has recently approved the Rapid Deployment Hemostat (RDH) bandage (Marine Polymer Technologies, Cambridge, MA) as a treatment for external bleeding after extremity trauma.
Jewelewicz D, Cohn S, Crookes B, et al. J Trauma. 2003;55:275–281 -
The RDH Bandage: Survival in a Lethal Aortotomy Hemorrhage Model
Eighty percent of the animals treated with the RDH Bandage survived the study through the entire protocol, whereas only 40% of those treated with the Army First Aid Field Bandage survived the removal of manual compression step.
Vournakis J, Demcheva M, Whitson AB, et al. J Surg Res. 2003; 113:1-5
* Data on file, based on total US sales