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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Autores principales: Kim, Byung Moon, Park, Keun Young, Lee, Jae Whan, Chung, Joonho, Kim, Dong Joon, Kim, Dong Ik
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Korean Society of Radiology 2019
Materias:
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.
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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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