Comparison of structural and hemostatic properties of the poly-N-acetyl glucosamine Syvek Patch with products containing chitosan.

Polysaccharides are becoming increasingly developed as therapeutics and medical products, as the new field of Glycomics expands. Glycosaminoglycans that contain N-acetyl glucosamine constituents have been the focus of research leading to medical devices. A new hemostatic bandage, the Syvek Patch, has been introduced in the recent past for the control of bleeding at vascular access sites in interventional cardiology and radiology procedures. This product consists of poly-N-acetyl glucosamine (pGlcNAc) isolated in a unique fiber crystalline structural form from the large-scale culture and processing of a marine diatom. The Syvek pGlcNAc fiber material has chemical, physical, and biological properties that result in its favorable performance as a hemostat. Two new products, the Clo-Sur PAD and ChitoSeal, have recently become available also as patch hemostats. These two products both use chitosan, another N-acetyl glucosamine containing glycosaminoglycan, as their active ingredient. Structural, chemical, and biological comparisons of Syvek pGlcNAc and chitosan reveal a number of important differences. Syvek pGlcNAc fibers contain approximately 50 fully acetylated, high molecular weight pGlcNAc molecules in a crystalline, three-dimensional beta structure array, and are insoluble. Chitosan is a low molecular weight mixed amorphous cationic polymer with no regular structure as a solid, and is water-soluble taking on a random coil configuration when in solution. These structural dissimilarities result in differences in the hemostatic properties of the two materials. Syvek pGlcNAc is able to significantly reduce the in vitro fibrin clot formation time of platelet-rich plasma samples and has the ability to cause aggregation of red blood cells in vitro. Chitosan is no better than gauze or other controls in these in vitro assays. The Syvek Patch is able to control the bleeding and cause hemostasis in a coagulopathic swine spleen-bleeding animal model 100% of the time, whereas Clo-Sur PAD was completely unsuccessful (0%) and ChitoSeal (25%) was worse than a gauze pad control (50%) in the same model. Syvek pGlcNAc fibers have structural and chemical properties that provide a unique basis for their ability to interact with blood components to cause hemostasis. Chitosan does not have the same properties and capabilities.