{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,8]],"date-time":"2026-08-08T08:46:36Z","timestamp":1786178796663,"version":"build-2736575974"},"reference-count":37,"publisher":"MDPI AG","issue":"13","license":[{"start":{"date-parts":[[2025,7,3]],"date-time":"2025-07-03T00:00:00Z","timestamp":1751500800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"VFlow Ltd., Modi\u2019in-Maccabim-Reot, Israel"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Venous sinus stenting is a promising treatment for intracranial venous disorders, such as idiopathic intracranial hypertension and pulsatile tinnitus, associated with transverse sinus stenosis. The VIVA Stent System (VSS) is a novel self-expanding braided venous stent designed to navigate tortuous cerebral venous anatomy. This preclinical study assessed the safety, thrombogenicity, and performance of the VSS in a swine model. Methods: Fifteen swine underwent bilateral internal mammary vein stenting with either the VSS (n = 9) or the PRECISE\u00ae PRO RX stent (n = 6, reference). Fluoroscopy and thrombogenicity assessments were conducted on the day of stenting, clinical pathology analysis was carried out throughout the in-life phase, and CT Venography was performed before sacrifice. Animals were sacrificed at 30 \u00b1 3 or 180 \u00b1 11 days post-stenting for necropsy and histological evaluation. Results: Fluoroscopic angiography confirmed the successful VSS deployment with complete venous wall apposition and no vessel damage. The VSS achieved the highest scores on a four-point Likert scale for most performance parameters. No thrombus formation was observed on either delivery system. CT Venography confirmed vessel patency, no stent migration, and complete stent integrity. Histopathology showed a mild, expected foreign body reaction at 30 days, which resolved by 180 days, indicating normal healing progression. Both stents showed increased luminal diameter and decreased wall thickness at 180 days, suggesting vessel recovery. No adverse reactions were observed in non-target organs. Conclusions: The VSS exhibited favorable safety, procedural performance, and thromboresistance in a swine model, supporting its potential clinical use for treating transverse sinus stenosis and related conditions.<\/jats:p>","DOI":"10.3390\/jcm14134721","type":"journal-article","created":{"date-parts":[[2025,7,3]],"date-time":"2025-07-03T09:57:39Z","timestamp":1751536659000},"page":"4721","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["VIVA Stent Preclinical Evaluation in Swine: A Novel Cerebral Venous Stent with a Unique Delivery System"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8606-8385","authenticated-orcid":false,"given":"Yuval","family":"Ramot","sequence":"first","affiliation":[{"name":"Department of Dermatology, Hadassah Medical Center, Jerusalem 9112001, Israel"},{"name":"Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem 7661041, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michal","family":"Steiner","sequence":"additional","affiliation":[{"name":"Independent Preclinical Consultant, Rehovot 7630511, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Udi","family":"Vazana","sequence":"additional","affiliation":[{"name":"LAHAV CRO, Kibbutz Lahav, D.N. Negev 85335, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7847-2513","authenticated-orcid":false,"given":"Abraham","family":"Nyska","sequence":"additional","affiliation":[{"name":"Independent Consultant in Toxicologic Pathology, Tel-Aviv University, Tel-Aviv 6997801, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7898-8272","authenticated-orcid":false,"given":"Anat","family":"Horev","sequence":"additional","affiliation":[{"name":"V-Flow 21 Ltd., Modi\u2019in-Maccabim-Re\u2019ut 7178594, Israel"},{"name":"Neurology Department, Soroka University Medical Center, Beer-Sheva 8410101, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,7,3]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1408","DOI":"10.3174\/ajnr.A2575","article-title":"Transverse sinus stenting for idiopathic intracranial hypertension: A review of 52 patients and of model predictions","volume":"32","author":"Ahmed","year":"2011","journal-title":"AJNR Am. 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