{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,24]],"date-time":"2026-06-24T10:19:58Z","timestamp":1782296398850,"version":"3.54.5"},"reference-count":20,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2025,3,15]],"date-time":"2025-03-15T00:00:00Z","timestamp":1741996800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Prenatal Diagnosis"],"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>The use of the Balt Goldbal\u2010balloon and Baltacci\u2010catheter in Fetoscopic Endoluminal Tracheal Occlusion is affected by the 2017\u2010European Medical Device Regulation, which necessitates recertification even for devices long considered safe. This regulation has led the manufacturer to stop distributing these devices in Europe. We alert fetal surgery centers to these challenges and regulators to the broader impact on the availability of fetal therapy devices in Europe.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We surveyed 50 fetal surgery centers worldwide and communicated directly with the manufacturer. Additionally, we provide updates on a new device under evaluation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The response rate among 39 balloon users was 95% (<jats:italic>n<\/jats:italic>\u00a0=\u00a037). Currently, all balloons in Europe are expired. Supply issues exist in Australasia and South\u2010America, with some distributors reporting discontinuation despite the manufacturer's communications on its sustained availability. Some centers manage shortages by importing from other countries. Balt has agreed to supply devices to European centers that obtain derogation by the national competent authorities, for which we cannot provide a generic procedure. An alternative device is unlikely to be marketed before 2026.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This scenario highlights the unintended consequences of stringent medical device regulations, leading to their unavailability for beneficial procedures or complicated administrative processes, even as these devices remain available outside the EU.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pd.6763","type":"journal-article","created":{"date-parts":[[2025,3,15]],"date-time":"2025-03-15T12:21:36Z","timestamp":1742041296000},"page":"539-543","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["The Fall Out of the 2017 European <i>Medical Device Regulation<\/i> for Tracheal Occlusion"],"prefix":"10.1002","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5029-7899","authenticated-orcid":false,"given":"Francesca","family":"Russo","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynaecology University Hospitals Leuven  Leuven Belgium"},{"name":"Workstream Fetal Medicine European Reference Network \u201cERNICA\u201d  Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6045-0765","authenticated-orcid":false,"given":"Alexandra","family":"Benachi","sequence":"additional","affiliation":[{"name":"Workstream Fetal Medicine European Reference Network \u201cERNICA\u201d  Belgium"},{"name":"Department of Obstetrics and Gynaecology H\u00f4pital Antoine B\u00e9cl\u00e8re Assistance Public\u2010H\u00f4pitaux de Paris Paris Saclay University  Clamart France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3210-4405","authenticated-orcid":false,"given":"Frank","family":"Meijer","sequence":"additional","affiliation":[{"name":"Congenitale Diafragmatische Hernia Platform  Arnhem the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fanny","family":"Cauvet","sequence":"additional","affiliation":[{"name":"Center for Rare Disease: Congenital Diaphragmatic Hernia  Clamart France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H\u00e9l\u00e8ne","family":"Berru\u00e9\u2010Gaillard","sequence":"additional","affiliation":[{"name":"Alliance Maladies Rares  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4224-4826","authenticated-orcid":false,"given":"Beverley","family":"Power","sequence":"additional","affiliation":[{"name":"Workstream Fetal Medicine European Reference Network \u201cERNICA\u201d  Belgium"},{"name":"CDH\u2010UK: The Congenital Diaphragmatic Hernia Charity  King's Lynn UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4920-945X","authenticated-orcid":false,"given":"Jan","family":"Deprest","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology University Hospitals Leuven  Leuven Belgium"},{"name":"Workstream Fetal Medicine European Reference Network \u201cERNICA\u201d  Belgium"},{"name":"University College London Institute for Women's Health  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,3,15]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1740\u20109713.2012.00616.x"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1017\/S0266462321000258"},{"key":"e_1_2_12_4_1","unstructured":"Accessed December 2024 https:\/\/www.eapaediatrics.eu\/eap\u2010urges\u2010urgent\u2010action\u2010to\u2010protect\u2010access\u2010to\u2010essential\u2010medical\u2010devices\u2010for\u2010children\u2010and\u2010other\u2010patients\/."},{"key":"e_1_2_12_5_1","unstructured":"Accessed December 2024 https:\/\/sales.rocketmedical.com\/media\/attachment\/file\/f\/s\/fsn_w_customer_response_form_28_oct_20.pdf."},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa2027030"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa2026983"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2021.11.1351"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/uog.26164"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/s1074\u20103804(96)80165\u20104"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/(sici)1097\u20100223(199707)17:7<629::aid\u2010pd120>3.3.co;2\u2010d"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/uog.1711"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/s2352\u20104642(24)00109\u20103"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/pd.5445"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/uog.22132"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/uog.23135"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0273878"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/pd.6474"},{"key":"e_1_2_12_19_1","unstructured":"D.De Luca N.Modi P.Davis et\u00a0al. \u201cThe Lancet Child and Adolescent Health Commission on the Future of Neonatology \u201d (submitted to Lancet Child Adolesc Health)."},{"key":"e_1_2_12_20_1","unstructured":"Accessed December 2024 https:\/\/www.euronews.com\/my\u2010europe\/2024\/12\/03\/health\u2010commissioner\u2010touts\u2010swifter\u2010reform\u2010of\u2010eu\u2010medical\u2010devices\u2010rules\u2010than\u2010expected."},{"key":"e_1_2_12_21_1","unstructured":"Accessed December 2024 https:\/\/ec.europa.eu\/info\/law\/better\u2010regulation\/have\u2010your\u2010say\/initiatives\/14155\u2010EU\u2010rules\u2010on\u2010medical\u2010devices\u2010and\u2010in\u2010vitro\u2010diagnostics\u2010targeted\u2010evaluation_en."}],"container-title":["Prenatal Diagnosis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pd.6763","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,11]],"date-time":"2025-04-11T13:36:53Z","timestamp":1744378613000},"score":1,"resource":{"primary":{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/10.1002\/pd.6763"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3,15]]},"references-count":20,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2025,4]]}},"alternative-id":["10.1002\/pd.6763"],"URL":"https:\/\/doi.org\/10.1002\/pd.6763","archive":["Portico"],"relation":{},"ISSN":["0197-3851","1097-0223"],"issn-type":[{"value":"0197-3851","type":"print"},{"value":"1097-0223","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,3,15]]},"assertion":[{"value":"2024-12-26","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-02-09","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-03-15","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}