The evaluation of the flow re-direction endoluminal device (FRED) for the treatment of selected intracranial aneurysms: a Polish multicenter study
Abstract This Polish multicenter study aims to evaluate the effectiveness and safety of the Flow Direction Endoluminal Device (FRED) in treating selected unruptured intracranial aneurysms. The FRED Poland Study was an observational, multicenter, prospective study conducted in 8 Polish investigationa...
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Nature Portfolio
2025-02-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-025-90463-9 |
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| author | Maciej Jaworski Remigiusz Krysiak Jarosław Żyłkowski Mariusz Banach Miłosz Zbroszczyk Kamila Smulska Sławomir Bereza Katarzyna Lubkowska Ewa Horoch-Łyszczarek Paweł Brzegowy Tadeusz Popiela Wojciech Poncyljusz Michał Zawadzki Błażej Nowak Mateusz Pinkiewicz Jarosław Wrzyszcz Katarzyna Mokrzycka Maciej Szajner Christophe Cognard Edoardo Boccardi Raphael Blanc Michel Piotin |
| author_facet | Maciej Jaworski Remigiusz Krysiak Jarosław Żyłkowski Mariusz Banach Miłosz Zbroszczyk Kamila Smulska Sławomir Bereza Katarzyna Lubkowska Ewa Horoch-Łyszczarek Paweł Brzegowy Tadeusz Popiela Wojciech Poncyljusz Michał Zawadzki Błażej Nowak Mateusz Pinkiewicz Jarosław Wrzyszcz Katarzyna Mokrzycka Maciej Szajner Christophe Cognard Edoardo Boccardi Raphael Blanc Michel Piotin |
| author_sort | Maciej Jaworski |
| collection | DOAJ |
| description | Abstract This Polish multicenter study aims to evaluate the effectiveness and safety of the Flow Direction Endoluminal Device (FRED) in treating selected unruptured intracranial aneurysms. The FRED Poland Study was an observational, multicenter, prospective study conducted in 8 Polish investigational sites. Imaging results were independently assessed by a Corelab and adverse events were adjudicated by a Clinical Events Committee (CEC). Clinical results up to 24 months and anatomical results at 6-, 12- and 24-months post-treatment were reported. A total of 86 patients with 89 target aneurysms were enrolled between January 2016 and September 2017. Most aneurysms were located on the anterior circulation (93.2%, 83/89 aneurysms) with the majority (64.0%, 57/89) being small (< 10 mm) in size. Treatment was successfully performed in 86 out of 89 cases (96.6%). The permanent neurological morbidity rate was 3.6%, and the neurological mortality rate was 2.4%. Imaging follow-up at 6 months showed complete occlusion of the aneurysm in 64.9% of cases, increasing to 79.5% at 12 months and 85.5% at 24 months. This study offers a comprehensive overview of the flow diversion treatment approach, demonstrating that the FRED device is effective and safe for use in intracranial aneurysm treatment. These results align with existing literature, reaffirming the device reliability and suitability for clinical use. |
| format | Article |
| id | doaj-art-05ad58316b794aee8a76a28cf2992802 |
| institution | DOAJ |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-02-01 |
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| spelling | doaj-art-05ad58316b794aee8a76a28cf29928022025-08-20T03:10:47ZengNature PortfolioScientific Reports2045-23222025-02-011511910.1038/s41598-025-90463-9The evaluation of the flow re-direction endoluminal device (FRED) for the treatment of selected intracranial aneurysms: a Polish multicenter studyMaciej Jaworski0Remigiusz Krysiak1Jarosław Żyłkowski2Mariusz Banach3Miłosz Zbroszczyk4Kamila Smulska5Sławomir Bereza6Katarzyna Lubkowska7Ewa Horoch-Łyszczarek8Paweł Brzegowy9Tadeusz Popiela10Wojciech Poncyljusz11Michał Zawadzki12Błażej Nowak13Mateusz Pinkiewicz14Jarosław Wrzyszcz15Katarzyna Mokrzycka16Maciej Szajner17Christophe Cognard18Edoardo Boccardi19Raphael Blanc20Michel Piotin21II Department of Clinical Radiology Warszawa, Medical University of WarsawII Department of Clinical Radiology Warszawa, Medical University of WarsawII Department of Clinical Radiology Warszawa, Medical University of WarsawDepartment of Neurosurgery Kraków, Saint Raphael HospitalDepartment of Radiodiagnostic and Interventional Radiology Katowice, Medical University of SilesiaDepartment of Radiodiagnostic and Interventional Radiology Katowice, Medical University of SilesiaDepartement of Interventional Neuroradiology Wrocław, Lower Silesian Specialistic Marciniak Memorial HospitalDepartement of Interventional Neuroradiology Wrocław, Lower Silesian Specialistic Marciniak Memorial HospitalDepartement of Neurology Wrocław, Lower Silesian Specialistic Marciniak Memorial HospitalRadiology Department Kraków, Medical College Jagiellonian UniversityRadiology Department Kraków, Medical College Jagiellonian UniversityDepartment of Diagnostic Imaging and Interventional Radiology Szczecin, Pomeranian Medical University in SzczecinDepartment of Radiology Warszawa, Central Clinical Hospital of the Ministry of Interior and Administration in Warsaw, Division of Interventional NeuroradiologyDepartment of Radiology Warszawa, Central Clinical Hospital of the Ministry of Interior and Administration in Warsaw, Division of Interventional NeuroradiologyDepartment of Radiology Warszawa, Central Clinical Hospital of the Ministry of Interior and Administration in Warsaw, Division of Interventional NeuroradiologyDepartment of Neurosurgery Grudziądz, Regional Specialist Hospital named after Dr. WI. BieganskiDepartment of Neurosurgery Grudziądz, Regional Specialist Hospital named after Dr. WI. BieganskiDepartment of Interventional Neuroradiology Lublin, Medical University of LublinDiagnostic and Therapeutic Neuroradiology Place du Dr Baylac Toulouse , Hôpital Purpan Neuroradiology Milano, Ospedale Niguarda Ca’GrandaDepartement of Interventional Neuroradiology Paris Fondation de Rothschild Departement of Interventional Neuroradiology Paris Fondation de Rothschild Abstract This Polish multicenter study aims to evaluate the effectiveness and safety of the Flow Direction Endoluminal Device (FRED) in treating selected unruptured intracranial aneurysms. The FRED Poland Study was an observational, multicenter, prospective study conducted in 8 Polish investigational sites. Imaging results were independently assessed by a Corelab and adverse events were adjudicated by a Clinical Events Committee (CEC). Clinical results up to 24 months and anatomical results at 6-, 12- and 24-months post-treatment were reported. A total of 86 patients with 89 target aneurysms were enrolled between January 2016 and September 2017. Most aneurysms were located on the anterior circulation (93.2%, 83/89 aneurysms) with the majority (64.0%, 57/89) being small (< 10 mm) in size. Treatment was successfully performed in 86 out of 89 cases (96.6%). The permanent neurological morbidity rate was 3.6%, and the neurological mortality rate was 2.4%. Imaging follow-up at 6 months showed complete occlusion of the aneurysm in 64.9% of cases, increasing to 79.5% at 12 months and 85.5% at 24 months. This study offers a comprehensive overview of the flow diversion treatment approach, demonstrating that the FRED device is effective and safe for use in intracranial aneurysm treatment. These results align with existing literature, reaffirming the device reliability and suitability for clinical use.https://doi.org/10.1038/s41598-025-90463-9 |
| spellingShingle | Maciej Jaworski Remigiusz Krysiak Jarosław Żyłkowski Mariusz Banach Miłosz Zbroszczyk Kamila Smulska Sławomir Bereza Katarzyna Lubkowska Ewa Horoch-Łyszczarek Paweł Brzegowy Tadeusz Popiela Wojciech Poncyljusz Michał Zawadzki Błażej Nowak Mateusz Pinkiewicz Jarosław Wrzyszcz Katarzyna Mokrzycka Maciej Szajner Christophe Cognard Edoardo Boccardi Raphael Blanc Michel Piotin The evaluation of the flow re-direction endoluminal device (FRED) for the treatment of selected intracranial aneurysms: a Polish multicenter study Scientific Reports |
| title | The evaluation of the flow re-direction endoluminal device (FRED) for the treatment of selected intracranial aneurysms: a Polish multicenter study |
| title_full | The evaluation of the flow re-direction endoluminal device (FRED) for the treatment of selected intracranial aneurysms: a Polish multicenter study |
| title_fullStr | The evaluation of the flow re-direction endoluminal device (FRED) for the treatment of selected intracranial aneurysms: a Polish multicenter study |
| title_full_unstemmed | The evaluation of the flow re-direction endoluminal device (FRED) for the treatment of selected intracranial aneurysms: a Polish multicenter study |
| title_short | The evaluation of the flow re-direction endoluminal device (FRED) for the treatment of selected intracranial aneurysms: a Polish multicenter study |
| title_sort | evaluation of the flow re direction endoluminal device fred for the treatment of selected intracranial aneurysms a polish multicenter study |
| url | https://doi.org/10.1038/s41598-025-90463-9 |
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