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Safety and Functionality of a Guidewire Fixator: Clinical Investigation of a New Endovascular Tool

OBJECTIVE: A new endovascular tool, the Liungman Guidewire Fixator, has been developed to simplify endovascular treatment in complex aortic aneurysms. The device has been extensively tested in bench models and animal trials. To verify the safety and functionality demonstrated in the porcine model, t...

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Autores principales: Liungman, Krister, Mani, Kevin, Wanhainen, Anders, Bosaeus, Linus, Lachat, Mario
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5865490/
https://www.ncbi.nlm.nih.gov/pubmed/29465630
http://dx.doi.org/10.1097/IMI.0000000000000468
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author Liungman, Krister
Mani, Kevin
Wanhainen, Anders
Bosaeus, Linus
Lachat, Mario
author_facet Liungman, Krister
Mani, Kevin
Wanhainen, Anders
Bosaeus, Linus
Lachat, Mario
author_sort Liungman, Krister
collection PubMed
description OBJECTIVE: A new endovascular tool, the Liungman Guidewire Fixator, has been developed to simplify endovascular treatment in complex aortic aneurysms. The device has been extensively tested in bench models and animal trials. To verify the safety and functionality demonstrated in the porcine model, the device was tested in ten patients undergoing endovascular aortic repair (EVAR) or fenestrated endovascular aortic repair (f-EVAR) treatment for abdominal aortic aneurysm. METHODS: The Liungman Guidewire Fixator consists of a braided stent-like, cylindrical structure with conical ends and a central channel for a 0.035″ guidewire. When in use, it is slid along the guidewire and positioned in the target artery, where the Liungman Guidewire Fixator interacts with the arterial wall by anchoring the guidewire to the wall through a radial force. The Liungman Guidewire Fixator allows for uninterrupted blood flow passed the point of fixation. In this study, the Liungman Guidewire Fixator was tested in ten patients undergoing EVAR or f-EVAR treatment for abdominal aortic aneurysm. The device was deployed and retrieved crossover into the hypogastric artery, and the occurrence of thrombotic occlusion, arterial dissection, and vascular rupture or trauma was studied using angiography, as well as device ability to withstand guidewire tension. RESULTS: There were no instances of occlusion, dissection, or vascular trauma detected using angiography. In all cases, deployment and retrieval were successful, and the devices could withstand an applied tension of 3 N. In one instance, retrieval was challenging because of significant tortuosity, which was resolved by a coaxial catheterization. CONCLUSIONS: Deployment was uneventful in all ten patients. Retrieval according to the intended instruction for use was performed in nine of the patients. In one patient, a coaxial catheterization was necessary. All devices withstood a retention force of 3 N.
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spelling pubmed-58654902018-04-04 Safety and Functionality of a Guidewire Fixator: Clinical Investigation of a New Endovascular Tool Liungman, Krister Mani, Kevin Wanhainen, Anders Bosaeus, Linus Lachat, Mario Innovations (Phila) Original Articles OBJECTIVE: A new endovascular tool, the Liungman Guidewire Fixator, has been developed to simplify endovascular treatment in complex aortic aneurysms. The device has been extensively tested in bench models and animal trials. To verify the safety and functionality demonstrated in the porcine model, the device was tested in ten patients undergoing endovascular aortic repair (EVAR) or fenestrated endovascular aortic repair (f-EVAR) treatment for abdominal aortic aneurysm. METHODS: The Liungman Guidewire Fixator consists of a braided stent-like, cylindrical structure with conical ends and a central channel for a 0.035″ guidewire. When in use, it is slid along the guidewire and positioned in the target artery, where the Liungman Guidewire Fixator interacts with the arterial wall by anchoring the guidewire to the wall through a radial force. The Liungman Guidewire Fixator allows for uninterrupted blood flow passed the point of fixation. In this study, the Liungman Guidewire Fixator was tested in ten patients undergoing EVAR or f-EVAR treatment for abdominal aortic aneurysm. The device was deployed and retrieved crossover into the hypogastric artery, and the occurrence of thrombotic occlusion, arterial dissection, and vascular rupture or trauma was studied using angiography, as well as device ability to withstand guidewire tension. RESULTS: There were no instances of occlusion, dissection, or vascular trauma detected using angiography. In all cases, deployment and retrieval were successful, and the devices could withstand an applied tension of 3 N. In one instance, retrieval was challenging because of significant tortuosity, which was resolved by a coaxial catheterization. CONCLUSIONS: Deployment was uneventful in all ten patients. Retrieval according to the intended instruction for use was performed in nine of the patients. In one patient, a coaxial catheterization was necessary. All devices withstood a retention force of 3 N. Lippincott Williams & Wilkins 2018-01 2018-02-21 /pmc/articles/PMC5865490/ /pubmed/29465630 http://dx.doi.org/10.1097/IMI.0000000000000468 Text en Copyright © 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Society for Minimally Invasive Cardiothoracic Surgery. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND) (http://creativecommons.org/licenses/by-nc-nd/4.0/) , where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
spellingShingle Original Articles
Liungman, Krister
Mani, Kevin
Wanhainen, Anders
Bosaeus, Linus
Lachat, Mario
Safety and Functionality of a Guidewire Fixator: Clinical Investigation of a New Endovascular Tool
title Safety and Functionality of a Guidewire Fixator: Clinical Investigation of a New Endovascular Tool
title_full Safety and Functionality of a Guidewire Fixator: Clinical Investigation of a New Endovascular Tool
title_fullStr Safety and Functionality of a Guidewire Fixator: Clinical Investigation of a New Endovascular Tool
title_full_unstemmed Safety and Functionality of a Guidewire Fixator: Clinical Investigation of a New Endovascular Tool
title_short Safety and Functionality of a Guidewire Fixator: Clinical Investigation of a New Endovascular Tool
title_sort safety and functionality of a guidewire fixator: clinical investigation of a new endovascular tool
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5865490/
https://www.ncbi.nlm.nih.gov/pubmed/29465630
http://dx.doi.org/10.1097/IMI.0000000000000468
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