{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T07:07:00Z","timestamp":1784531220656,"version":"3.55.0"},"reference-count":25,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2026,2,6]],"date-time":"2026-02-06T00:00:00Z","timestamp":1770336000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Vasc Access"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Conventional intraosseous (IO) access is typically reserved for emergency situations and limited to short-term use (\u2a7d48\u2009h). We introduce a novel, fully subcutaneous IO device designed to provide stable, longer-term vascular access in non-emergent settings. This device may benefit patients requiring intravenous therapies with challenging venous access or chronic kidney disease (CKD) who need to preserve peripheral and central veins for future arteriovenous fistula creation for hemodialysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim and methods:<\/jats:title>\n                    <jats:p>This prospective, single-arm, first-in-human study evaluated the feasibility and safety of the fully subcutaneous IO device over a 7-day implant with daily infusions in patients with challenging venous access or CKD. Patency was assessed radiographically after placement, clinically during infusion visits, and either radiographically or clinically before explant. Usability and tolerability were evaluated through clinician and patient surveys. Safety was assessed by monitoring device-related adverse events for 30\u2009days after explant.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Ten patients were successfully implanted with the device, and patency was maintained for a full 7-day duration without routine maintenance. Clinicians reported easy device implant, use, and explant. Three patients experienced pain during the first medullary infusion; one had additional pain during the second and third infusions. No patient discomfort was reported after day three. No adverse device effects (ADEs) occurred during the study or follow-up.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>This novel, fully subcutaneous IO device appears to be a feasible, usable, and safe option for short-term infusion therapy in patients with CKD or challenging venous access. These findings support further investigation into its use as a long-term intraosseous vascular access option.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/11297298261415957","type":"journal-article","created":{"date-parts":[[2026,2,6]],"date-time":"2026-02-06T10:52:56Z","timestamp":1770375176000},"page":"1669-1677","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["First-in-human evaluation of a novel subcutaneous intraosseous vascular access device for outpatient infusions"],"prefix":"10.1177","volume":"27","author":[{"given":"Jorge H","family":"Ulloa","sequence":"first","affiliation":[{"name":"Clinica de Venas, Faculty of Medicine, Universidad de los Andes, Bogot\u00e1, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David J","family":"Sabbag","sequence":"additional","affiliation":[{"name":"Department of Radiology, Sabbag Radiologos, Barranquilla, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier E","family":"del Castillo","sequence":"additional","affiliation":[{"name":"Department of Radiology, Sabbag Radiologos, Barranquilla, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-1059-1154","authenticated-orcid":false,"given":"Alexa","family":"Rueda","sequence":"additional","affiliation":[{"name":"PAVmed Inc., New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-7128-2919","authenticated-orcid":false,"given":"Victoria T","family":"Lee","sequence":"additional","affiliation":[{"name":"PAVmed Inc., New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lishan","family":"Aklog","sequence":"additional","affiliation":[{"name":"PAVmed Inc., New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian J","family":"deGuzman","sequence":"additional","affiliation":[{"name":"PAVmed Inc., New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,2,6]]},"reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1177\/1129729818804994"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2013070759"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.5527\/wjn.v1.i3.69"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-139X.2008.00421.x"},{"issue":"10","key":"e_1_3_2_6_2","article-title":"Rescue access made easy","volume":"30","author":"Miller L","year":"2005","unstructured":"Miller L, Kramer GC, Bolleter S. Rescue access made easy. JEMS 2005; 30(10): suppl 8\u201318; quiz suppl 9.","journal-title":"JEMS"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1186\/s13054-016-1277-6"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.annemergmed.2011.07.020"},{"key":"e_1_3_2_9_2","volume":"112","author":"2005 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care","year":"2005","unstructured":"2005 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. 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Bent metal in a bone: a rare complication of an emergent procedure or a deficiency in skill set? Case Rep Crit Care 2016; 2016: 4382481.","journal-title":"Case Rep Crit Care"},{"key":"e_1_3_2_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.resuscitation.2011.08.017"},{"key":"e_1_3_2_19_2","doi-asserted-by":"publisher","DOI":"10.1080\/10903127.2016.1247201"},{"key":"e_1_3_2_20_2","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1K168"},{"key":"e_1_3_2_21_2","doi-asserted-by":"publisher","DOI":"10.1111\/jocn.13750"},{"key":"e_1_3_2_22_2","doi-asserted-by":"publisher","DOI":"10.1017\/ice.2016.276"},{"key":"e_1_3_2_23_2","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-031-61201-5_10"},{"key":"e_1_3_2_24_2","volume-title":"StatPearls","author":"Dornhofer P","year":"2025","unstructured":"Dornhofer P, McMahon K, Kellar JZ. Intraosseous vascular access. In: StatPearls. 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