1. Evaluation of a biocompatible sealant for on-demand repair of vascular defects-a chronic study in a large animal model.
- Author
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Wussler D, Kiefer S, Naumann S, Hackner D, Nadjiri J, Meckel S, Haberstroh J, Kubicki R, Seifert A, Siepe M, Ewert P, Stiller B, and Lang N
- Subjects
- Animals, Disease Models, Animal, Swine, Biocompatible Materials, Carotid Arteries surgery, Jugular Veins surgery, Proteins pharmacology, Tissue Adhesives pharmacology, Vascular Diseases surgery
- Abstract
Objectives: Existing surgical sealants fail to combine design requirements, such as sealing performance, on-demand activation and biocompatibility. The aim of this study was to compare the effectiveness and safety of the SETALIUM™ Vascular Sealant (SVS), a novel, on-demand activatable sealant, with the commercial sealant, BioGlue®, for the repair of vascular defects., Methods: In an in vivo porcine model, the use of SVS was compared with BioGlue, for sealing 2-mm defects of the carotid artery and jugular vein. Animals were followed for 7 days and 5 weeks (each time point and per experimental group, n = 4), respectively. The degree of stenosis and flow velocity was determined, and the local tissue response was evaluated., Results: In vivo incision closure succeeded in all cases, and SVS was superior in clinical usability, enabled by its on-demand activation. Unlike BioGlue, SVS use did not induce stenosis and was associated with physiological blood flow in all cases. Moreover, closure with SVS was associated with a low inflammatory reaction and no thrombus formation or intima proliferation, in contrast to BioGlue., Conclusions: SVS demonstrated effective and rapid sealing of 2-mm vascular defects, with favourable biocompatibility compared to BioGlue. Thus, SVS seems to be an effective and safe vascular sealant., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)
- Published
- 2020
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