{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T09:06:19Z","timestamp":1784711179816,"version":"3.55.0"},"reference-count":45,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T00:00:00Z","timestamp":1775088000000},"content-version":"vor","delay-in-days":1,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T00:00:00Z","timestamp":1775001600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Biomedical Materials Res"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Poly(ether)urethanes (PEUs) are widely used in long term implanted medical devices. Their susceptibility to oxidative degradation has raised concerns regarding compatibility with vaporized hydrogen peroxide (VH\n                    <jats:sub>2<\/jats:sub>\n                    O\n                    <jats:sub>2<\/jats:sub>\n                    ) sterilization. This study investigates the chemical and mechanical stability of PEU80A, a Shore 80A durometer PEU, following exposure to VH\n                    <jats:sub>2<\/jats:sub>\n                    O\n                    <jats:sub>2<\/jats:sub>\n                    sterilization. Two VH\n                    <jats:sub>2<\/jats:sub>\n                    O\n                    <jats:sub>2<\/jats:sub>\n                    sterilization conditions were characterized, three times (nominal) and 10 times (extreme) the cycle required for cardiac pacemaker sterilization and compared to two solution\u2010based hydrogen peroxide exposures, with and without cobalt chloride catalyst. Compared to the extreme VH\n                    <jats:sub>2<\/jats:sub>\n                    O\n                    <jats:sub>2<\/jats:sub>\n                    condition, the solution exposure conditions were four orders of magnitude higher in concentration and 40\u2010fold longer in duration. Comprehensive characterization of PEU80A included molar mass analysis, antioxidant quantification, mechanical testing, free radical profiling, soft segment loss assessment, exhaustive chemical extraction, and evaluations of hemocompatibility and cytotoxicity. The results demonstrated that VH\n                    <jats:sub>2<\/jats:sub>\n                    O\n                    <jats:sub>2<\/jats:sub>\n                    sterilization did not induce any detectable degradation in PEU80A, even after 3\u2009years of real\u2010time aging post VH\n                    <jats:sub>2<\/jats:sub>\n                    O\n                    <jats:sub>2<\/jats:sub>\n                    exposure. Only the catalyzed solution exposure resulted in measurable oxidative degradation, evidenced by antioxidant depletion, molar mass reduction, soft segment depletion, and mechanical weakening. Despite these changes, the comprehensive testing for chemical extractables, hemocompatibility, and cytotoxicity, used to evaluate biocompatibility, remained unaffected. These findings demonstrated the continued oxidative stability and biocompatibility of PEU80A after VH\n                    <jats:sub>2<\/jats:sub>\n                    O\n                    <jats:sub>2<\/jats:sub>\n                    sterilization, supporting its use as a terminal sterilization method for implantable devices comprised of this material. Furthermore, these data suggest that the biostability of a material is impacted long before any changes in biocompatibility can be resolved.\n                  <\/jats:p>","DOI":"10.1002\/jbm.a.70067","type":"journal-article","created":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T08:25:33Z","timestamp":1775118333000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Material Compatibility of Poly(Ether)urethane\n                    <scp>80A<\/scp>\n                    With Vaporized Hydrogen Peroxide Sterilization: A Comprehensive Evaluation of Oxidative Stability and Biocompatibility"],"prefix":"10.1002","volume":"114","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7812-3121","authenticated-orcid":false,"given":"Kimberly A.","family":"Chaffin","sequence":"first","affiliation":[{"name":"Global Technology and Innovation, Medtronic Inc  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric K.","family":"Long","sequence":"additional","affiliation":[{"name":"Global Technology and Innovation, Medtronic Inc  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela L.","family":"Hendrickx","sequence":"additional","affiliation":[{"name":"Global Technology and Innovation, Medtronic Inc  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Augie","family":"Witkowski","sequence":"additional","affiliation":[{"name":"Global Technology and Innovation, Medtronic Inc  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie A.","family":"Alkatout","sequence":"additional","affiliation":[{"name":"Global Technology and Innovation, Medtronic Inc  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ioan P. I.","family":"Gitsov","sequence":"additional","affiliation":[{"name":"Global Technology and Innovation, Medtronic Inc  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maruti N.","family":"Sinha","sequence":"additional","affiliation":[{"name":"Global Technology and Innovation, Medtronic Inc  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael F.","family":"Wolf","sequence":"additional","affiliation":[{"name":"Global Technology and Innovation, Medtronic Inc  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah","family":"Jeffers","sequence":"additional","affiliation":[{"name":"Global Technology and Innovation, Medtronic Inc  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matt","family":"Jolly","sequence":"additional","affiliation":[{"name":"Global Technology and Innovation, Medtronic Inc  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nameera","family":"Wegner","sequence":"additional","affiliation":[{"name":"Center for Devices and Radiological Health, FDA  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Eppihimer","sequence":"additional","affiliation":[{"name":"Center for Devices and Radiological Health, FDA  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,4,2]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"U.S. Food and Drug Administration \u201cFDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization \u201dhttps:\/\/www.fda.gov\/news\u2010events\/press\u2010announcements\/fda\u2010facilitates\u2010broader\u2010adoption\u2010vaporized\u2010hydrogen\u2010peroxide\u2010medical\u2010device\u2010sterilization."},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.2345\/0899\u20108205\u201054.s3.74"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.3109\/08941939809032183"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1177\/13548565211014464"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1149\/1.2754073"},{"key":"e_1_2_10_7_1","unstructured":"J. M.Van DineandJ. R.McCormick \u201cSterilization of Articles Using Vaporized Hydrogen Peroxide. US Patent 5 628 774. Issued May 13 1997 \u201d (2025) https:\/\/patents.google.com\/patent\/US5628774A\/en."},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540\u20108159.1986.tb06688.x"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2024.02.062"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1177\/088532829500900402"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/jbm.a.30800"},{"key":"e_1_2_10_12_1","unstructured":"U.S. Food and Drug Administration \u201cSubmission of Research and Marketing Applications for Permanent Pacemaker Leads and Pacemaker Lead Adaptor \u201d (2025) https:\/\/www.fda.gov\/medical\u2010devices\/guidance\u2010documents\u2010medical\u2010devices\u2010and\u2010radiation\u2010emitting\u2010products\/submission\u2010research\u2010and\u2010marketing\u2010applications\u2010permanent\u2010pacemaker\u2010leads\u2010and\u2010pacemaker\u2010lead\u2010adaptor."},{"key":"e_1_2_10_13_1","first-page":"109","volume-title":"Polyurethanes in Biomedical Engineering II","author":"Stokes K.","year":"1987"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1163\/156856290X00062"},{"key":"e_1_2_10_15_1","unstructured":"International Organization for Standardization (ISO) \u201cISO 10993\u201013:2010. Biological Evaluation of Medical Devices \u2013 Part 13: Identification and Quantification of Degradation Products From Polymeric Medical Devices. Geneva Switzerland: ISO \u201d (2010) https:\/\/nhiso.com\/wp\u2010content\/uploads\/2018\/05\/ISO\u201010993\u201013\u20102010.pdf."},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.actbio.2017.06.030"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijerph17186841"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1021\/ed076p1517"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1177\/088532820001400402"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/jbm.a.30555"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/0032\u20103861(92)90280\u2010A"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097\u20104636(19970315)34:4<519::AID\u2010JBM12>3.0.CO;2\u20107"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0142\u20109612(97)00083\u20105"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/app.1992.070460202"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/jbm.a.30067"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biomaterials.2008.04.007"},{"key":"e_1_2_10_27_1","unstructured":"International Organization for Standardization (ISO) \u201cISO 22441:2022. Sterilization of Health Care Products\u2014Low Temperature Vaporized Hydrogen Peroxide\u2014Requirements for the Development Validation and Routine Control of a Sterilization Process for Medical Devices Geneva Switzerland ISO \u201d (2022)."},{"key":"e_1_2_10_28_1","unstructured":"International Organization for Standardization (ISO) \u201cISO 10993\u20104:2017. Biological Evaluation of Medical Devices\u2014Part 4: Selection of Tests for Interactions With Blood Geneva Switzerland ISO \u201d (2017)."},{"key":"e_1_2_10_29_1","unstructured":"International Organization for Standardization (ISO) \u201cISO 10993\u20105:2009. Biological Evaluation of Medical Devices\u2014Part 5: Tests for In\u00a0Vitro Cytotoxicity Geneva Switzerland ISO \u201d (2009)."},{"key":"e_1_2_10_30_1","unstructured":"D. N.Robinson J. M.Warakomski J. N.Argyropoulos andC. L.Weckle \u201cPolyurethane polymer. 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