A Newly-Developed Flow Diverter (FloWise) for Internal Carotid Artery Aneurysm: Results of a Pilot Clinical Study
OBJECTIVE: We report the results of a pilot clinical study that evaluated the safety and efficacy of a newly-developed, retrievable flow diverter (FloWise; Taewoong Medical) for the treatment of internal carotid artery (ICA) aneurysm. MATERIALS AND METHODS: A total of 10 patients were enrolled. Incl...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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The Korean Society of Radiology
2019
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6389806/ https://www.ncbi.nlm.nih.gov/pubmed/30799582 http://dx.doi.org/10.3348/kjr.2018.0421 |
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author | Kim, Byung Moon Park, Keun Young Lee, Jae Whan Chung, Joonho Kim, Dong Joon Kim, Dong Ik |
author_facet | Kim, Byung Moon Park, Keun Young Lee, Jae Whan Chung, Joonho Kim, Dong Joon Kim, Dong Ik |
author_sort | Kim, Byung Moon |
collection | PubMed |
description | OBJECTIVE: We report the results of a pilot clinical study that evaluated the safety and efficacy of a newly-developed, retrievable flow diverter (FloWise; Taewoong Medical) for the treatment of internal carotid artery (ICA) aneurysm. MATERIALS AND METHODS: A total of 10 patients were enrolled. Inclusion criteria were 1) unruptured aneurysm with a dome size of ≥ 8 mm and a neck size of ≥ 4 mm at the ICA, or 2) two or more unruptured aneurysms of any size able to be spanned by a single FloWise at the ICA. Co-primary effectiveness end points were technical success of FloWise placement, and a 50% or greater decrease in aneurysm volume at the 6-month follow-up angiogram. The primary safety end point was the new development of neurological deficits persisting for more than 1-month post-treatment. RESULTS: Ten patients harboring 14 ICA aneurysms (median diameter, 9.4 mm; range, 2.3–31.0 mm) were enrolled between January 2016 and July 2017. FloWise placement was successful in all patients. There were no newly-developed neurological deficits during the 6-month clinical follow-up period. One patient did not receive follow-up imaging due to pregnancy. Nine patients with 12 aneurysms received a 6-month angiographic follow-up. Ten aneurysms (83.3%) showed decreases in volume greater than 50% (mean volume decrease, 82.8 ± 32.9%), of which 8 (66.7%, 95% confidence interval, 35.4–98.0%) showed complete occlusion. One patient was retreated due to mass symptom aggravation. CONCLUSIONS: In this pilot study, FloWise appeared to be safe and effective for ICA aneurysm treatment. A prospective multicenter study to validate the effectiveness and safety of FloWise would be worthwhile. |
format | Online Article Text |
id | pubmed-6389806 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | The Korean Society of Radiology |
record_format | MEDLINE/PubMed |
spelling | pubmed-63898062019-03-05 A Newly-Developed Flow Diverter (FloWise) for Internal Carotid Artery Aneurysm: Results of a Pilot Clinical Study Kim, Byung Moon Park, Keun Young Lee, Jae Whan Chung, Joonho Kim, Dong Joon Kim, Dong Ik Korean J Radiol Neurointervention OBJECTIVE: We report the results of a pilot clinical study that evaluated the safety and efficacy of a newly-developed, retrievable flow diverter (FloWise; Taewoong Medical) for the treatment of internal carotid artery (ICA) aneurysm. MATERIALS AND METHODS: A total of 10 patients were enrolled. Inclusion criteria were 1) unruptured aneurysm with a dome size of ≥ 8 mm and a neck size of ≥ 4 mm at the ICA, or 2) two or more unruptured aneurysms of any size able to be spanned by a single FloWise at the ICA. Co-primary effectiveness end points were technical success of FloWise placement, and a 50% or greater decrease in aneurysm volume at the 6-month follow-up angiogram. The primary safety end point was the new development of neurological deficits persisting for more than 1-month post-treatment. RESULTS: Ten patients harboring 14 ICA aneurysms (median diameter, 9.4 mm; range, 2.3–31.0 mm) were enrolled between January 2016 and July 2017. FloWise placement was successful in all patients. There were no newly-developed neurological deficits during the 6-month clinical follow-up period. One patient did not receive follow-up imaging due to pregnancy. Nine patients with 12 aneurysms received a 6-month angiographic follow-up. Ten aneurysms (83.3%) showed decreases in volume greater than 50% (mean volume decrease, 82.8 ± 32.9%), of which 8 (66.7%, 95% confidence interval, 35.4–98.0%) showed complete occlusion. One patient was retreated due to mass symptom aggravation. CONCLUSIONS: In this pilot study, FloWise appeared to be safe and effective for ICA aneurysm treatment. A prospective multicenter study to validate the effectiveness and safety of FloWise would be worthwhile. The Korean Society of Radiology 2019-03 2019-01-21 /pmc/articles/PMC6389806/ /pubmed/30799582 http://dx.doi.org/10.3348/kjr.2018.0421 Text en Copyright © 2019 The Korean Society of Radiology http://creativecommons.org/licenses/by-nc/3.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Neurointervention Kim, Byung Moon Park, Keun Young Lee, Jae Whan Chung, Joonho Kim, Dong Joon Kim, Dong Ik A Newly-Developed Flow Diverter (FloWise) for Internal Carotid Artery Aneurysm: Results of a Pilot Clinical Study |
title | A Newly-Developed Flow Diverter (FloWise) for Internal Carotid Artery Aneurysm: Results of a Pilot Clinical Study |
title_full | A Newly-Developed Flow Diverter (FloWise) for Internal Carotid Artery Aneurysm: Results of a Pilot Clinical Study |
title_fullStr | A Newly-Developed Flow Diverter (FloWise) for Internal Carotid Artery Aneurysm: Results of a Pilot Clinical Study |
title_full_unstemmed | A Newly-Developed Flow Diverter (FloWise) for Internal Carotid Artery Aneurysm: Results of a Pilot Clinical Study |
title_short | A Newly-Developed Flow Diverter (FloWise) for Internal Carotid Artery Aneurysm: Results of a Pilot Clinical Study |
title_sort | newly-developed flow diverter (flowise) for internal carotid artery aneurysm: results of a pilot clinical study |
topic | Neurointervention |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6389806/ https://www.ncbi.nlm.nih.gov/pubmed/30799582 http://dx.doi.org/10.3348/kjr.2018.0421 |
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