A Newly-Developed Flow Diverter (FloWise) for Internal Carotid Artery Aneurysm: Results of a Pilot Clinical Study

Korean Journal of Radiology : Official Journal of the Korean Radiological Society
Byung Moon KimDong Ik Kim

Abstract

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. 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. 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 greate...Continue Reading

References

May 31, 2003·Stroke; a Journal of Cerebral Circulation·Jean RaymondDaniel Roy
Aug 9, 2008·AJNR. American Journal of Neuroradiology·B M KimB C Suh
Apr 17, 2009·AJNR. American Journal of Neuroradiology·D F KallmesH J Cloft
Sep 15, 2009·AJNR. American Journal of Neuroradiology·B M KimY S Won
Nov 30, 2011·Neurointervention·Byung Moon KimDong Ik Kim
Mar 14, 2013·Korean Journal of Radiology : Official Journal of the Korean Radiological Society·Yon-Kwon IhnDong Ik Kim
Sep 18, 2013·Korean Journal of Radiology : Official Journal of the Korean Radiological Society·Myung Ho RhoDong Ik Kim
Jan 23, 2016·Korean Journal of Radiology : Official Journal of the Korean Radiological Society·Byung Moon KimDong Ik Kim
Sep 2, 2017·Korean Journal of Radiology : Official Journal of the Korean Radiological Society·Yongxin ZhangJianmin Liu
Mar 13, 2018·Journal of Korean Neurosurgical Society·Tackeun KimSeung Pil Ban

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Citations

May 16, 2020·Stroke and Vascular Neurology·Jessica K CamposAlexander L Coon
Dec 20, 2019·Korean Journal of Radiology : Official Journal of the Korean Radiological Society·Yeon Hyeon Choe
Nov 26, 2020·Korean Journal of Radiology : Official Journal of the Korean Radiological Society·Yeon Hyeon Choe
May 1, 2021·Life·Antonis AdamouPanagiotis Papanagiotou

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Software Mentioned

FloWise
SPSS

Related Concepts

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Aneurysm

Aneurysms are outward distensions or bulges that occurs in a weakened wall of blood vessels. Discover the latest research on aneurysms here.

Carotid Artery Diseases

Carotid artery disease is a group of pathological conditions of the carotid artery. Discover the latest research on carotid artery disease here.

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