{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T18:50:59Z","timestamp":1789671059215,"version":"4.0.1"},"reference-count":113,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"4","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Quality and Outcomes"],"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:sec>\n            <jats:title>BACKGROUND:<\/jats:title>\n            <jats:p>The authorization process and coverage\/reimbursement mechanisms for medical devices play critical roles in device adoption and usage. However, international variation in these processes remains poorly characterized, especially with regard to data transparency and the effects of reimbursement on usage.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>METHODS:<\/jats:title>\n            <jats:p>This study examined publicly available databases, governmental agency recommendations and policies, and press releases from the United States, Canada, the United Kingdom, and the Netherlands to compare the regulatory approval processes and coverage\/reimbursement mechanisms for 2 novel cardiovascular devices introduced in the early and late 2000\u2019s: the Watchman left atrial appendage occlusion device and the Impella percutaneous ventricular assist device. In addition to qualitative comparisons for each country, this study compared the date of the first regulatory review, time from submission to review completion, device approval date, agency approval requirements, number of review cycles, and necessity of postapproval studies as determined by the regulator, date of funding decision, final funding decision, and requirements for device reimbursement by relevant government payors.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS:<\/jats:title>\n            <jats:p>Authorization data were easily accessible for the United States and Canada but extremely limited for the United Kingdom and the Netherlands. Chronologically, authorization occurred \u224810 years earlier in Europe (United Kingdom and the Netherlands) than in North America (United States and Canada) for both devices. The United States was the only country where the principal public payor (Medicare) explicitly reimbursed both procedures. The United States was similarly notable for more rapid adoption and higher utilization of both devices than the other countries, with the Watchman implanted at 3.4 devices per 100\u2005000 adults annually and Impella used in 7 to 8 procedures per 100\u2005000 people annually. In contrast, uptake was far lower in Canada and Europe.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSIONS:<\/jats:title>\n            <jats:p>This research provides insights into how differences among countries in authorization and reimbursement mechanisms may impact the adoption and usage of medical devices, and may inform future policies on these processes.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/circoutcomes.124.011636","type":"journal-article","created":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T10:01:03Z","timestamp":1740132063000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"title":["Variations in the Medical Device Authorization and Reimbursement Landscape: A Case Study of 2 Cardiovascular Devices Across 4 Countries"],"prefix":"10.1161","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-9065-7398","authenticated-orcid":true,"given":"Marta M.","family":"Williams","sequence":"first","affiliation":[{"name":"Department of Health Care Policy, Harvard Medical School, Boston, MA (M.A.W., B.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4765-9975","authenticated-orcid":true,"given":"Nathan R.","family":"Smith","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Baylor College of Medicine, Houston, TX (N.R.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5808-302X","authenticated-orcid":true,"given":"Carin A.","family":"Uyl-de Groot","sequence":"additional","affiliation":[{"name":"Department of Health Care Policy and Management, Erasmus University Rotterdam, The Netherlands (C.A.U.-d.G., C.A.d.U.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0635-2843","authenticated-orcid":true,"given":"Corstiaan A.","family":"den Uil","sequence":"additional","affiliation":[{"name":"Department of Health Care Policy and Management, Erasmus University Rotterdam, The Netherlands (C.A.U.-d.G., C.A.d.U.)."},{"name":"Department of Cardiology and the Department of Intensive Care Medicine, Maasstad Hospital, Rotterdam, The Netherlands (C.A.d.U.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9218-3320","authenticated-orcid":true,"given":"Joseph S.","family":"Ross","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and the Department of Healthy Policy and Management and the Institution for Social and Policy Studies, Yale School of Medicine, New Haven, CT (J.S.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9678-5222","authenticated-orcid":true,"given":"Mohamed O.","family":"Mohamed","sequence":"additional","affiliation":[{"name":"Institute of Health Informatics, University College London, United Kingdom (M.O.M., A.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9241-8890","authenticated-orcid":true,"given":"Mamas A.","family":"Mamas","sequence":"additional","affiliation":[{"name":"Keele Cardiovascular Research Group, Keele University, Staffordshire, United Kingdom (M.A.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8741-3411","authenticated-orcid":true,"given":"Amitava","family":"Banerjee","sequence":"additional","affiliation":[{"name":"Institute of Health Informatics, University College London, United Kingdom (M.O.M., A.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6840-8051","authenticated-orcid":true,"given":"Dennis T.","family":"Ko","sequence":"additional","affiliation":[{"name":"Schulich Heart Center, Sunnybrook Health Sciences Centre, Toronto, ON, Canada (D.T.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4912-0647","authenticated-orcid":true,"given":"Bruce","family":"Landon","sequence":"additional","affiliation":[{"name":"Department of Health Care Policy, Harvard Medical School, Boston, MA (M.A.W., B.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1910-346X","authenticated-orcid":true,"given":"Peter","family":"Cram","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Maryland, Baltimore (P.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsa054744"},{"key":"e_1_3_3_3_2","unstructured":"U.S. Food and Drug Administration. 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Cited April 8 2024. https:\/\/projects.iq.harvard.edu\/ihsrc\/home"},{"key":"e_1_3_3_18_2","unstructured":"World Heart Report 2023: full report - World Heart Federation. Cited July 7 2024. https:\/\/world-heart-federation.org\/resource\/world-heart-report-2023\/"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCOUTCOMES.123.010144"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.1699"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2021-069164"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMhle1113918"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2023.3961"},{"key":"e_1_3_3_24_2","unstructured":"GOV.UK. Regulating medical devices in the UK. 2023; Cited June 19 2023. https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-in-the-uk"},{"key":"e_1_3_3_25_2","unstructured":"National Institute for Healthcare Excellence. Technology appraisal guidance. NICE; Cited July 13 2024. https:\/\/www.nice.org.uk\/about\/what-we-do\/our-programmes\/nice-guidance\/nice-technology-appraisal-guidance"},{"key":"e_1_3_3_26_2","unstructured":"REGULATION (EU) 2017\/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices amending Directive 2001\/83\/EC Regulation (EC) No 178\/2002 and Regulation (EC) No 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EEC. Official Journal of the European Union; 2017. Cited June 23 2024. https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/HTML\/?uri=CELEX%3A32017R0745"},{"key":"e_1_3_3_27_2","unstructured":"Devices@FDA. WATCHMAN Left Atrial Appendage (LAA) closure technology. Cited April 21 2023. https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/devicesatfda\/index.cfm?db=pma&id=320552"},{"key":"e_1_3_3_28_2","unstructured":"Government of Canada HC. 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Ontario percutaneous left atrial appendage closure patient eligibility criteria guidelines & facility quality criteria. 2019; Cited August 4 2024. https:\/\/www.corhealthontario.ca\/Ontario-Percutaneous-LAAC-Patient-Eligibility-Criteria-Guidelines-and-Facility-Quality-Criteria.pdf"},{"key":"e_1_3_3_38_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cjco.2023.07.006"},{"key":"e_1_3_3_39_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cjco.2023.03.016"},{"key":"e_1_3_3_40_2","unstructured":"NHS England. Clinical Commissioning Policy: Left Atrial Appendage Occlusion for patients with atrial fibrillation and relative or absolute contraindications to anticoagulation (adults). Cited June 29 2023. https:\/\/www.england.nhs.uk\/publication\/clinical-commissioning-policy-left-atrial-appendage-occlusion-for-patients-with-atrial-fibrillation-and-relative-or-absolute-contraindications-to-anticoagulation-adults\/"},{"key":"e_1_3_3_41_2","unstructured":"Ministerie van Volksgezondheid W en S. 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Cited October 21 2023. https:\/\/digital.nhs.uk\/services\/data-registers-service"},{"key":"e_1_3_3_63_2","doi-asserted-by":"publisher","DOI":"10.15420\/aer.2020.03"},{"key":"e_1_3_3_64_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2022.05.001"},{"key":"e_1_3_3_65_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.119.044007"},{"key":"e_1_3_3_66_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2020.37748"},{"key":"e_1_3_3_67_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.121.011778"},{"key":"e_1_3_3_68_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2020.07.037"},{"key":"e_1_3_3_69_2","unstructured":"Boston Scientific. Fiscal Year (FY) 2019 Hospital inpatient proposed rule interventional cardiology peripheral interventions & rhythm management. 2018; Cited March 7 2024. https:\/\/www.bostonscientific.com\/content\/dam\/bostonscientific\/Reimbursement\/RhythmManagement\/2018\/CRV-547314-AA%20PR2019%20IPPS%20Customer%20Communication_PSST.pdf"},{"key":"e_1_3_3_70_2","unstructured":"Began M; United States Securities and Exchange Commission. United States Securities and Exchange Commission Form 8-K for Abiomed Inc. 2019; Cited April 21 2023. https:\/\/www.sec.gov\/Archives\/edgar\/data\/815094\/000156459019012599\/abmd-8k_20190423.htm"},{"key":"e_1_3_3_71_2","unstructured":"Abiomed. Protected PCI with Impella\u00ae. Cited June 24 2024. https:\/\/www.heartrecovery.com\/conditions\/protected-pci"},{"key":"e_1_3_3_72_2","doi-asserted-by":"publisher","DOI":"10.1016\/s0828-282x(08)70199-5"},{"key":"e_1_3_3_73_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12630-020-01755-9"},{"key":"e_1_3_3_74_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cjco.2020.05.001"},{"key":"e_1_3_3_75_2","unstructured":"National Institute for Healthcare Excellence. Impella 2.5 for haemodynamic support during high-risk percutaneous coronary interventions. NICE; 2016; Cited June 20 2023. https:\/\/www.nice.org.uk\/advice\/mib89"},{"key":"e_1_3_3_76_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaccas.2019.11.024"},{"key":"e_1_3_3_77_2","unstructured":"NICOR. National Percutaneous coronary interventions (NAPCI). 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Guidance on clinical evidence requirements for medical devices: submitting clinical evidence. 2021; Cited May 30 2023. https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/application-information\/guidance-documents\/clinical-evidence-requirements-medical-devices\/submitting-clinical-evidence.html"},{"key":"e_1_3_3_84_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2024.4682"},{"key":"e_1_3_3_85_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp2305280"},{"key":"e_1_3_3_86_2","doi-asserted-by":"publisher","DOI":"10.3390\/healthcare11030447"},{"key":"e_1_3_3_87_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10198-006-0028-z"},{"key":"e_1_3_3_88_2","doi-asserted-by":"publisher","DOI":"10.2165\/00148365-200605030-00004"},{"key":"e_1_3_3_89_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciab612"},{"key":"e_1_3_3_90_2","doi-asserted-by":"publisher","DOI":"10.1055\/s-2003-42863"},{"key":"e_1_3_3_91_2","doi-asserted-by":"crossref","unstructured":"Current use of implantable electrical devices in Sweden: data from the Swedish pacemaker and implantable cardioverter-defibrillator registry. 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Medicare\u2019s \u201cCoverage with evidence development\u201d: a barrier to patient access and innovation. Health Affairs Forefront. Cited October 21 2023. https:\/\/www.healthaffairs.org\/do\/10.1377\/forefront.20230428.275268\/full\/"},{"key":"e_1_3_3_99_2","unstructured":"Health Canada. Canada\u2019s Health Care System. 2011; Cited May 24 2023. https:\/\/www.canada.ca\/en\/health-canada\/services\/health-care-system\/reports-publications\/health-care-system\/canada.html"},{"key":"e_1_3_3_100_2","unstructured":"Ontario Ministry of Health. Ontario Schedule of Benefits Physician Services Under the Health Insurance Act. 2023 . https:\/\/www.ontario.ca\/page\/ohip-schedule-benefits-and-fees."},{"key":"e_1_3_3_101_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cjca.2019.10.018"},{"key":"e_1_3_3_102_2","unstructured":"Health Canada. Medical devices active licences search. Cited May 24 2023. https:\/\/health-products.canada.ca\/mdall-limh\/prepareSearch?type=active"},{"key":"e_1_3_3_103_2","unstructured":"Government of Canada HC. Drug and Health Product Register. 2014; Cited May 24 2023. https:\/\/hpr-rps.hres.ca\/reg-content\/summary-basis-decision.php"},{"key":"e_1_3_3_104_2","unstructured":"Ontario Government. Data catalogue. Ontario Case Costing Initiative (OCCI). Cited September 30 2023. https:\/\/data.ontario.ca\/dataset\/ontario-case-costing-initiative-occi"},{"key":"e_1_3_3_105_2","unstructured":"About BSI. Business Standards Company. Cited September 5 2023. https:\/\/www.bsigroup.com\/en-US\/about-bsi\/"},{"key":"e_1_3_3_106_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i3323"},{"key":"e_1_3_3_107_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12913-021-06229-2"},{"key":"e_1_3_3_108_2","unstructured":"Ministerie van Volksgezondheid W en S. English - Nederlandse Zorgautoriteit. Ministerie van Volksgezondheid Welzijn en Sport; 2017. 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