{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T22:07:26Z","timestamp":1792534046907,"version":"4.5.0"},"reference-count":36,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2026,1,29]],"date-time":"2026-01-29T00:00:00Z","timestamp":1769644800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100002543","name":"Pusan National University","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100002543","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Bioengineering"],"abstract":"<jats:p>Polyurethane-based implantable devices (PUIDs) delivered via catheter are increasingly used in structural heart interventions; however, limited in vivo data exist regarding their long-term biostability and biological safety. This study evaluated a balloon-shaped implant made of Pellethane\u00ae, a polyether-based polyurethane, designed as a three-dimensional intracardiac spacer and deployed via percutaneous femoral vein access. The device was chronically positioned adjacent to the tricuspid valve annulus in seven pigs for 24 weeks. Explanted devices and surrounding tissues were evaluated through material characterization (SEM, GPC, FT-IR, and 1H-NMR) and histological analysis. SEM and FT-IR confirmed preserved surface morphology and chemical bonds, GPC showed stable molecular weight, and 1H-NMR revealed intact urethane and ether linkages. Materials characterization revealed no evidence of hydrolytic or oxidative degradation, indicating structural stability of the devices. Histological analysis showed stable device positioning with minimal thrombosis or inflammatory response. Biocompatibility was confirmed via ISO 10993-1:2018 Standard (International Organization for Standardization (ISO): Geneva, Switzerland, 2018), and extractable substances were evaluated under exhaustive extraction conditions specified by ISO 10993-18:2020 (International Organization for Standardization (ISO): Geneva, Switzerland, 2020), with no toxicologically significant findings. These findings support the long-term biostability and biological safety of the PUIDs in dynamic cardiac environments, informing future design criteria for catheter-delivered cardiovascular devices.<\/jats:p>","DOI":"10.3390\/bioengineering13020168","type":"journal-article","created":{"date-parts":[[2026,1,29]],"date-time":"2026-01-29T10:08:57Z","timestamp":1769681337000},"page":"168","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Chronic In Vivo Biostability and Biocompatibility Evaluation of Polyether-Urethane-Based Balloon Implants for Cardiac Application in a Porcine Model"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-0899-4495","authenticated-orcid":false,"given":"Min-Gi","family":"Kim","sequence":"first","affiliation":[{"name":"Department of Polymer Science and Engineering, Pusan National University, Busan 46241, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-7665-0631","authenticated-orcid":false,"given":"Jae-Young","family":"Seo","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, School of Medicine, Pusan National University, Busan 49241, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0653-0929","authenticated-orcid":false,"given":"June-hong","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Cardiology, Cardiovascular Center, Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan 50612, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-6089-5895","authenticated-orcid":false,"given":"Jin-Chang","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Clinical Bio-Convergence, Pusan National University, Busan 46241, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun-Yong","family":"Park","sequence":"additional","affiliation":[{"name":"Department of R&D Center, Tau Medical Inc., Busan 50612, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hyun-A","family":"Song","sequence":"additional","affiliation":[{"name":"Department of R&D Center, Tau Medical Inc., Busan 50612, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyeong-Deok","family":"Song","sequence":"additional","affiliation":[{"name":"Department of R&D Center, Tau Medical Inc., Busan 50612, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0183-6996","authenticated-orcid":false,"given":"Min-Ku","family":"Chon","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Cardiology, Cardiovascular Center, Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan 50612, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,1,29]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"729","DOI":"10.1163\/156856299X00612","article-title":"Commercial polyurethanes: The potential influence of auxiliary chemicals on the biodegradation process","volume":"10","author":"Vermette","year":"1999","journal-title":"J. Biomater. Sci. Polym. Ed."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"245","DOI":"10.1016\/S0964-8305(02)00051-3","article-title":"Biodegradation of polyurethane: A review","volume":"49","author":"Howard","year":"2002","journal-title":"Int. Biodeterior. Biodegrad."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"113","DOI":"10.1081\/PDT-120003494","article-title":"Hydrolysis in pharmaceutical formulations","volume":"7","author":"Waterman","year":"2002","journal-title":"Pharm. Dev. Technol."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"11149","DOI":"10.1021\/acs.chemrev.1c00071","article-title":"Structurally dynamic hydrogels for biomedical applications: Pursuing a fine balance between macroscopic stability and microscopic dynamics","volume":"121","author":"Zhang","year":"2021","journal-title":"Chem. Rev."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"1334","DOI":"10.1016\/j.hrthm.2024.02.062","article-title":"Evaluation of the in vivo chemical reactivity of a novel copolymer insulation on cardiac leads in a single-center study","volume":"21","author":"Ibrahim","year":"2024","journal-title":"Heart Rhythm"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"225","DOI":"10.1016\/0142-9612(82)90024-2","article-title":"Polyether polyurethanes for implantable pacemaker leads","volume":"3","author":"Stokes","year":"1982","journal-title":"Biomaterials"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"9110","DOI":"10.1021\/ma301965y","article-title":"Influence of water on the structure and properties of PDMS-containing multiblock polyurethanes","volume":"45","author":"Chaffin","year":"2012","journal-title":"Macromolecules"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"1793","DOI":"10.1021\/acsmacrolett.0c00685","article-title":"Longevity expectations for polymers in medical devices demand new approaches to evaluating their biostability","volume":"9","author":"Chaffin","year":"2020","journal-title":"ACS Macro Lett."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"4033","DOI":"10.3390\/ijms10094033","article-title":"Degradability of polymers for implantable biomedical devices","volume":"10","author":"Lyu","year":"2009","journal-title":"Int. J. Mol. Sci."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"321","DOI":"10.1177\/088532829500900402","article-title":"Polyurethane elastomer biostability","volume":"9","author":"Stokes","year":"1995","journal-title":"J. Biomater. Appl."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"034004","DOI":"10.1088\/0022-3727\/44\/3\/034004","article-title":"Adhesion\u2013delamination phenomena at the surfaces and interfaces in microelectronics and MEMS structures and packaged devices","volume":"44","author":"Khanna","year":"2010","journal-title":"J. Phys. D Appl. Phys."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"3418","DOI":"10.1021\/acs.chemrev.8b00336","article-title":"Understanding degradation mechanisms and improving stability of perovskite photovoltaics","volume":"119","author":"Boyd","year":"2018","journal-title":"Chem. Rev."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"6224","DOI":"10.1039\/C9CS00822E","article-title":"Degradation-by-design: How chemical functionalization enhances the biodegradability and safety of 2D materials","volume":"49","author":"Ma","year":"2020","journal-title":"Chem. Soc. Rev."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"4291","DOI":"10.1039\/C8TA10306B","article-title":"Recent advances in oxidation and degradation mechanisms of ultrathin 2D materials under ambient conditions and their passivation strategies","volume":"7","author":"Li","year":"2019","journal-title":"J. Mater. Chem. A"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"214052","DOI":"10.1016\/j.bioadv.2024.214052","article-title":"Bismuth-infused perivascular wrap facilitates delivery of mesenchymal stem cells and attenuation of neointimal hyperplasia in rat arteriovenous fistulas","volume":"166","author":"Barcena","year":"2025","journal-title":"Biomater. Adv."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"33159","DOI":"10.1021\/acsami.4c06042","article-title":"Controlled delivery of rosuvastatin or rapamycin through electrospun bismuth nanoparticle-infused perivascular wraps promotes arteriovenous fistula maturation","volume":"16","author":"Barcena","year":"2024","journal-title":"ACS Appl. Mater. Interfaces"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"1211","DOI":"10.1016\/j.jcin.2018.02.041","article-title":"Management of Coronary Artery Aneurysms","volume":"11","author":"Kawsara","year":"2018","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"5220","DOI":"10.1021\/ma500904d","article-title":"Polyether urethane hydrolytic stability after exposure to deoxygenated water","volume":"47","author":"Chaffin","year":"2014","journal-title":"Macromolecules"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"109454","DOI":"10.1016\/j.polymdegradstab.2020.109454","article-title":"Combination of in vitro thermally-accelerated ageing and Fourier-Transform Infrared spectroscopy to predict scaffold lifetime","volume":"183","author":"Langueh","year":"2021","journal-title":"Polym. Degrad. Stab."},{"key":"ref_20","doi-asserted-by":"crossref","unstructured":"Adams, J.A., Uryash, A., and Lopez, J.R. (2022). Non-invasive pulsatile shear stress modifies endothelial activation; a narrative review. Biomedicines, 10.","DOI":"10.3390\/biomedicines10123050"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"167","DOI":"10.1586\/17434440.5.2.167","article-title":"Biological effects of dynamic shear stress in cardiovascular pathologies and devices","volume":"5","author":"Girdhar","year":"2008","journal-title":"Expert Rev. Med. Devices"},{"key":"ref_22","first-page":"1249","article-title":"A novel device for tricuspid regurgitation reduction featuring 3-dimensional leaflet and atraumatic anchor: Pivot-TR system","volume":"7","author":"Chon","year":"2022","journal-title":"Basic Transl. Sci."},{"key":"ref_23","doi-asserted-by":"crossref","unstructured":"Chon, M.-K., Jung, S.-J., Seo, J.-Y., Shin, D.-H., Park, J.-H., Kim, H.-S., Hahn, J.-Y., Kim, E.-K., Lee, S.-W., and Park, Y.-H. (2023). The Development of a Permanent Implantable Spacer with the Function of Size Adjustability for Customizing Treat Regurgitant Heart Valve Disease. Bioengineering, 10.","DOI":"10.3390\/bioengineering10091016"},{"key":"ref_24","unstructured":"(2024). Cardiovascular Implants and Extracorporeal Systems\u2014Cardiac Valve Repair Devices (Standard No. ISO 5910:2024)."},{"key":"ref_25","doi-asserted-by":"crossref","unstructured":"Funk, K.A., Hampshire, V.A., and Schuh, J.C. (2018). Nonclinical safety evaluation of medical devices. Toxicologic Pathology, CRC Press.","DOI":"10.1201\/9780429504624-4"},{"key":"ref_26","doi-asserted-by":"crossref","unstructured":"Fadilah, N.I.M., Ahmat, N., Hao, L.Q., Maarof, M., Rajab, N.F., Idrus, R.B.H., and Fauzi, M.B. (2023). Biological safety assessments of high-purified ovine collagen type I biomatrix for future therapeutic product: International Organisation for Standardisation (ISO) and Good Laboratory Practice (GLP) settings. Polymers, 15.","DOI":"10.3390\/polym15112436"},{"key":"ref_27","unstructured":"(2023). Biological Evaluation of Medical Devices\u2014Part 17: Toxicological Risk Assessment of Medical Device Constituents (Standard No. ISO 10993-17:2023)."},{"key":"ref_28","unstructured":"(2020). Biological Evaluation of Medical Devices\u2014Part 18: Chemical Characterization of Medical Device Materials within a Risk Management Process (Standard No. ISO 10993-18:2020)."},{"key":"ref_29","doi-asserted-by":"crossref","unstructured":"Albert, D. (2012). Material and chemical characterization for the biological evaluation of medical device biocompatibility. Biocompatibility and Performance of Medical Devices, Elsevier.","DOI":"10.1533\/9780857096456.2.63"},{"key":"ref_30","doi-asserted-by":"crossref","unstructured":"Wang, H.-M.D., Thakur, P., and Thakur, A. (2023). Biocompatibility, bio-clearance, and toxicology. Integrated Nanomaterials and Their Applications, Springer.","DOI":"10.1007\/978-981-99-6105-4_10"},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"939","DOI":"10.1021\/acsbiomaterials.1c01119","article-title":"Chemical characterization and non-targeted analysis of medical device extracts: A review of current approaches, gaps, and emerging practices","volume":"8","author":"Sussman","year":"2022","journal-title":"ACS Biomater. Sci. Eng."},{"key":"ref_32","unstructured":"Food and Drug Administration (FDA) (2026, January 13). ICH Q3E Guideline for Extractables and Leachables: Supporting Documentation\u2014Class 3 Leachable Monographs, Available online: https:\/\/www.fda.gov\/media\/189891\/download."},{"key":"ref_33","unstructured":"National Center for Biotechnology Information (NCBI) (2026, January 13). PubChem Compound Summary for CID 5365371. Bethesda (MD): National Library of Medicine (US), Available online: https:\/\/pubchem.ncbi.nlm.nih.gov\/compound\/5365371."},{"key":"ref_34","unstructured":"National Center for Biotechnology Information (NCBI) (2026, January 13). PubChem Compound Summary for Irganox 1076. Bethesda (MD): National Library of Medicine (US), Available online: https:\/\/pubchem.ncbi.nlm.nih.gov\/compound\/Irganox-1076."},{"key":"ref_35","doi-asserted-by":"crossref","unstructured":"Goetjes, V., Zarges, J.-C., and Heim, H.-P. (2024). Differentiation between hydrolytic and thermo-oxidative degradation of poly (lactic acid) and poly (lactic acid)\/starch composites in warm and humid environments. Materials, 17.","DOI":"10.3390\/ma17153683"},{"key":"ref_36","doi-asserted-by":"crossref","unstructured":"Liu, Y., Li, S., Wang, X., and Zhang, L. (2024). Review of the use of metals in biomedical applications: Biocompatibility, additive manufacturing technologies, and standards and regulations. Metals, 14.","DOI":"10.3390\/met14091039"}],"container-title":["Bioengineering"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2306-5354\/13\/2\/168\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,31]],"date-time":"2026-01-31T05:16:37Z","timestamp":1769836597000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2306-5354\/13\/2\/168"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,1,29]]},"references-count":36,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2026,2]]}},"alternative-id":["bioengineering13020168"],"URL":"https:\/\/doi.org\/10.3390\/bioengineering13020168","relation":{},"ISSN":["2306-5354"],"issn-type":[{"value":"2306-5354","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1,29]]}}}