{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T22:46:57Z","timestamp":1791931617129,"version":"4.3.4"},"reference-count":33,"publisher":"Journal of Neurosurgery Publishing Group (JNSPG)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,4,1]]},"abstract":"<jats:sec>\n<jats:title>OBJECTIVE<\/jats:title>\n<jats:p>Flow diversion created a paradigm shift in the treatment of intracranial aneurysms. The new flow redirection endoluminal device with X technology (FRED X) is the latest update of the recent Food and Drug Administration\u2013approved FRED. The FRED X is engineered to reduce material thrombogenicity and enhance vessel healing. In this study, the authors aimed to evaluate the feasibility and early safety and efficacy of the new FRED X.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>METHODS<\/jats:title>\n<jats:p>The authors retrospectively collected and analyzed data from patients who had undergone flow diversion with the new FRED X at four tertiary cerebrovascular centers in the United States from February 2022 through July 2022.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>RESULTS<\/jats:title>\n<jats:p>Forty-four patients with 45 aneurysms treated using 46 devices comprised the overall study cohort and were divided into two groups: 39 patients with unruptured aneurysms and 5 patients with ruptured aneurysms. The mean patient age was 57.7 \u00b1 9.1 years, and most patients were female (84%). Ninety-one percent of the aneurysms were saccular, with the majority (93%) located in the anterior circulation, specifically the posterior communicating (27%) and carotid ophthalmic (27%) territories. The mean maximum aneurysm diameter was 5.6 \u00b1 4.6 mm, and 20% of the lesions had been previously treated. The mean procedure time was 61.6 minutes, with a mean cumulative fluoroscopy time of 24.6 minutes. Additionally, 7% of the lesions received adjunct treatment. Stent placement was successful in 100% of cases, achieving good wall apposition and complete neck coverage. Further, immediate aneurysm contrast stasis &gt; 90% was observed in 61% of cases. Symptomatic postoperative complications occurred in 3 patients in the unruptured cohort and 1 patient in the ruptured cohort. All patients in the study were discharged on dual antiplatelet regimens with a modified Rankin Scale score of 0. At 6 months after treatment, 89% of cases had adequate occlusion, with &lt; 6% of cases having asymptomatic in-stent stenosis. All patients had excellent functional outcomes.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>CONCLUSIONS<\/jats:title>\n<jats:p>FRED X for the treatment of an intracranial aneurysm is technically feasible alone or in conjunction with intrasaccular embolization. In addition, the study results showed very promising early safety and efficacy. Follow-up studies should establish the long-term safety and efficacy profiles of this new stent.<\/jats:p>\n<\/jats:sec>","DOI":"10.3171\/2023.7.jns23966","type":"journal-article","created":{"date-parts":[[2023,10,7]],"date-time":"2023-10-07T01:38:50Z","timestamp":1696642730000},"page":"1054-1063","source":"Crossref","is-referenced-by-count":17,"title":["First United States multicenter experience with the new-generation FRED X surface-modified flow diversion stent: feasibility, safety, and short-term efficacy"],"prefix":"10.3171","volume":"140","author":[{"given":"Rawad","family":"Abbas","sequence":"first","affiliation":[{"name":"Department of Neurological Surgery, Thomas Jefferson University Hospital, Philadelphia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthews","family":"Lan","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery, Thomas Jefferson University Hospital, Philadelphia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kareem El","family":"Naamani","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery, Thomas Jefferson University Hospital, Philadelphia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elias","family":"Atallah","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery, Thomas Jefferson University Hospital, Philadelphia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed","family":"Salem","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Hospital of the University of Pennsylvania, Penn Medicine, Philadelphia, Pennsylvania;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan-Karl","family":"Burkhardt","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Hospital of the University of Pennsylvania, Penn Medicine, Philadelphia, Pennsylvania;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna Luisa","family":"K\u00fchn","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, University of Massachusetts, Boston, Massachusetts;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ajit","family":"Puri","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, University of Massachusetts, Boston, Massachusetts;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andre","family":"Monteiro","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, University of Buffalo, Buffalo, New York; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elad I.","family":"Levy","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, University of Buffalo, Buffalo, New York; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nabeel A.","family":"Herial","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery, Thomas Jefferson University Hospital, Philadelphia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. Reid","family":"Gooch","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery, Thomas Jefferson University Hospital, Philadelphia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey","family":"Jabbour","sequence":"additional","affiliation":[{"name":"Germantown Friends School, Philadelphia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Rosenwasser","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery, Thomas Jefferson University Hospital, Philadelphia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stavropoula I.","family":"Tjoumakaris","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery, Thomas Jefferson University Hospital, Philadelphia;"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1754","reference":[{"issue":"1","key":"b1","series-title":"J Neurosurg Anesthesiol","first-page":"61","article-title":"Microsurgery and clipping: the gold standard for the treatment of intracranial aneurysms","volume":"15","author":"Chicoine MR","year":"2003","unstructured":"Chicoine MR. Microsurgery and clipping: the gold standard for the treatment of intracranial aneurysms. J Neurosurg Anesthesiol. 2003;15(1):61\u201363."},{"issue":"4","key":"b2","series-title":"Arch Neurol","first-page":"559","article-title":"Guglielmi detachable coiling for intracranial aneurysms: the story so far","volume":"58","author":"Dovey Z","year":"2001","unstructured":"Dovey Z, Misra M, Thornton J, Charbel FT, Debrun GM, Ausman JI. Guglielmi detachable coiling for intracranial aneurysms: the story so far. Arch Neurol. 2001;58(4):559\u2013564."},{"issue":"3","key":"b3","series-title":"Radiology","first-page":"858","article-title":"Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial","volume":"267","author":"Becske T","year":"2013","unstructured":"Becske T, Kallmes DF, Saatci I,  Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial. Radiology. 2013;267(3):858\u2013868."},{"key":"b4","series-title":"Stroke Res Treat","first-page":"415653","article-title":"Flow diverters for intracranial aneurysms","volume":"2014","author":"Alderazi YJ","year":"2014","unstructured":"Alderazi YJ, Shastri D, Kass-Hout T, Prestigiacomo CJ, Gandhi CD. Flow diverters for intracranial aneurysms. Stroke Res Treat. 2014;2014:415653."},{"issue":"3","key":"b5","series-title":"Interv Neuroradiol","first-page":"347","article-title":"Flow redirection endoluminal device (FRED) for treatment of intracranial aneurysms: a systematic review","volume":"28","author":"Waqas M","year":"2022","unstructured":"Waqas M, Dossani RH, Alkhaldi M,  Flow redirection endoluminal device (FRED) for treatment of intracranial aneurysms: a systematic review. Interv Neuroradiol. 2022;28(3):347\u2013357."},{"issue":"1","key":"b6","series-title":"Neurosurgery","first-page":"118","article-title":"Comparison of flow-redirection endoluminal device and pipeline embolization device in the treatment of intracerebral aneurysms","volume":"92","author":"El Naamani K","year":"2023","unstructured":"El Naamani K, Saad H, Chen CJ,  Comparison of flow-redirection endoluminal device and pipeline embolization device in the treatment of intracerebral aneurysms. Neurosurgery. 2023;92(1):118\u2013124."},{"issue":"1","key":"b7","series-title":"J Neurointerv Surg","first-page":"54","article-title":"Review of current intracranial aneurysm flow diversion technology and clinical use","volume":"13","author":"Dandapat S","year":"2021","unstructured":"Dandapat S, Mendez-Ruiz A, Mart\u00ednez-Gald\u00e1mez M,  Review of current intracranial aneurysm flow diversion technology and clinical use. J Neurointerv Surg. 2021;13(1):54\u201362."},{"issue":"2","key":"b8","series-title":"Expert Rev Med Devices","first-page":"137","article-title":"The Pipeline embolization device for treatment of intracranial aneurysms","volume":"11","author":"Eller JL","year":"2014","unstructured":"Eller JL, Dumont TM, Sorkin GC,  The Pipeline embolization device for treatment of intracranial aneurysms. Expert Rev Med Devices. 2014;11(2):137\u2013150."},{"issue":"10","key":"b9","series-title":"AJNR Am J Neuroradiol","first-page":"1930","article-title":"Perianeurysmal brain inflammation after flow-diversion treatment","volume":"32","author":"Berge J","year":"2011","unstructured":"Berge J, Tourdias T, Moreau JF, Barreau X, Dousset V. Perianeurysmal brain inflammation after flow-diversion treatment. AJNR Am J Neuroradiol. 2011;32(10):1930\u20131934."},{"issue":"3","key":"b10","series-title":"Interv Neuroradiol","first-page":"300","article-title":"Long-term occlusion results with SILK flow diversion in 28 aneurysms: do recanalizations occur during follow-up?","volume":"21","author":"Mpotsaris A","year":"2015","unstructured":"Mpotsaris A, Skalej M, Beuing O, Eckert B, Behme D, Weber W. Long-term occlusion results with SILK flow diversion in 28 aneurysms: do recanalizations occur during follow-up? Interv Neuroradiol. 2015;21(3):300\u2013310."},{"key":"b11","series-title":"J Neurointerv Surg","article-title":"Long-term outcomes of flow diversion for unruptured intracranial aneurysms: a systematic review and meta-analysis","author":"Shehata MA","unstructured":"Shehata MA, Ibrahim MK, Ghozy S,  Long-term outcomes of flow diversion for unruptured intracranial aneurysms: a systematic review and meta-analysis. J Neurointerv Surg. Published online September 23, 2022. doi:10.1136\/jnis-2022-019240"},{"key":"b12","series-title":"World Neurosurg","first-page":"e1116","article-title":"Safety and efficacy of bilateral flow diversion for treatment of anterior circulation cerebral aneurysms","volume":"130","author":"Sweid A","year":"2019","unstructured":"Sweid A, Rahm SP, Das S,  Safety and efficacy of bilateral flow diversion for treatment of anterior circulation cerebral aneurysms. World Neurosurg. 2019;130:e1116\u2013e1121."},{"issue":"8","key":"b13","series-title":"JAMA Neurol","first-page":"1002","article-title":"Flow diversion for the treatment of intracranial aneurysms","volume":"73","author":"Walcott BP","year":"2016","unstructured":"Walcott BP, Stapleton CJ, Choudhri O, Patel AB. Flow diversion for the treatment of intracranial aneurysms. JAMA Neurol. 2016;73(8):1002\u20131008."},{"issue":"1","key":"b14","series-title":"AJNR Am J Neuroradiol","first-page":"134","article-title":"Flow-diversion treatment for unruptured nonsaccular intracranial aneurysms of the posterior and distal anterior circulation: a meta-analysis","volume":"41","author":"Cagnazzo F","year":"2020","unstructured":"Cagnazzo F, Lefevre PH, Derraz I,  Flow-diversion treatment for unruptured nonsaccular intracranial aneurysms of the posterior and distal anterior circulation: a meta-analysis. AJNR Am J Neuroradiol. 2020;41(1):134\u2013139."},{"issue":"4","key":"b15","series-title":"Neurosurgery","first-page":"730","article-title":"Predictors of complications, functional outcome, and morbidity in a large cohort treated with flow diversion","volume":"87","author":"Sweid A","year":"2020","unstructured":"Sweid A, Starke RM, Herial N,  Predictors of complications, functional outcome, and morbidity in a large cohort treated with flow diversion. Neurosurgery. 2020;87(4):730\u2013743."},{"issue":"6","key":"b16","series-title":"Neurosurgery","first-page":"875","article-title":"In-Pipeline stenosis: incidence, predictors, and clinical outcomes","volume":"77","author":"Chalouhi N","year":"2015","unstructured":"Chalouhi N, Polifka A, Daou B,  In-Pipeline stenosis: incidence, predictors, and clinical outcomes. Neurosurgery. 2015;77(6):875\u2013879."},{"issue":"10","key":"b17","series-title":"AJNR Am J Neuroradiol","first-page":"1959","article-title":"Multicenter experience with FRED Jr flow re-direction endoluminal device for intracranial aneurysms in small arteries","volume":"38","author":"M\u00f6hlenbruch MA","year":"2017","unstructured":"M\u00f6hlenbruch MA, Kizilkilic O, Killer-Oberpfalzer M,  Multicenter experience with FRED Jr flow re-direction endoluminal device for intracranial aneurysms in small arteries. AJNR Am J Neuroradiol. 2017;38(10):1959\u20131965."},{"key":"b18","series-title":"Clin Neurol Neurosurg","first-page":"107483","article-title":"Treatment of cerebral aneurysms with the FRED Jr flow-diverting stent: a case series and meta-analysis","volume":"223","author":"El Naamani K","year":"2022","unstructured":"El Naamani K, Saiegh FA, Chen CJ,  Treatment of cerebral aneurysms with the FRED Jr flow-diverting stent: a case series and meta-analysis. Clin Neurol Neurosurg. 2022;223:107483."},{"issue":"26","key":"b19","series-title":"N Engl J Med","first-page":"2474","article-title":"The natural course of unruptured cerebral aneurysms in a Japanese cohort","volume":"366","author":"Morita A","year":"2012","unstructured":"Morita A, Kirino T, Hashi K,  The natural course of unruptured cerebral aneurysms in a Japanese cohort. N Engl J Med. 2012;366(26):2474\u20132482."},{"issue":"9378","key":"b20","series-title":"Lancet","first-page":"103","article-title":"Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment","volume":"362","author":"Wiebers DO","year":"2003","unstructured":"Wiebers DO, Whisnant JP, Huston J III,  Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003;362(9378):103\u2013110."},{"issue":"1","key":"b21","series-title":"Neurosurgery","first-page":"40","article-title":"Long-term clinical and angiographic outcomes following Pipeline Embolization Device treatment of complex internal carotid artery aneurysms: five-year results of the Pipeline for Uncoilable or Failed Aneurysms trial","volume":"80","author":"Becske T","year":"2017","unstructured":"Becske T, Brinjikji W, Potts MB,  Long-term clinical and angiographic outcomes following Pipeline Embolization Device treatment of complex internal carotid artery aneurysms: five-year results of the Pipeline for Uncoilable or Failed Aneurysms trial. Neurosurgery. 2017;80(1):40\u201348."},{"issue":"1","key":"b22","series-title":"J Neurointerv Surg","first-page":"62","article-title":"Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results","volume":"12","author":"Hanel RA","year":"2020","unstructured":"Hanel RA, Kallmes DF, Lopes DK,  Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results. J Neurointerv Surg. 2020;12(1):62\u201366."},{"issue":"6","key":"b23","series-title":"Stroke","first-page":"1473","article-title":"SCENT trial","volume":"50","author":"Meyers PM","year":"2019","unstructured":"Meyers PM, Coon AL, Kan PT, Wakhloo AK, Hanel RA. SCENT trial. Stroke. 2019;50(6):1473\u20131479."},{"issue":"10","key":"b24","series-title":"J Neurointerv Surg","first-page":"974","article-title":"First clinical experience with the new Surpass Evolve flow diverter: technical and clinical considerations","volume":"12","author":"Orru E","year":"2020","unstructured":"Orru E, Rice H, De Villiers L,  First clinical experience with the new Surpass Evolve flow diverter: technical and clinical considerations. J Neurointerv Surg. 2020;12(10):974\u2013980."},{"issue":"2","key":"b25","series-title":"J Neurointerv Surg","first-page":"184","article-title":"SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results","volume":"11","author":"Pierot L","year":"2019","unstructured":"Pierot L, Spelle L, Berge J,  SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results. J Neurointerv Surg. 2019;11(2):184\u2013189."},{"issue":"9","key":"b26","series-title":"J Neurointerv Surg","first-page":"628","article-title":"Classification of cavernous internal carotid artery tortuosity: a predictor of procedural complexity in Pipeline embolization","volume":"7","author":"Lin LM","year":"2015","unstructured":"Lin LM, Colby GP, Jiang B,  Classification of cavernous internal carotid artery tortuosity: a predictor of procedural complexity in Pipeline embolization. J Neurointerv Surg. 2015;7(9):628\u2013633."},{"issue":"4","key":"b27","series-title":"Asian J Neurosurg","first-page":"1240","article-title":"Endovascular rescue strategies for nonopening of Pipeline device: report of two cases","volume":"14","author":"Mahajan A","year":"2019","unstructured":"Mahajan A, Banga V, Chatterjee A, Goel G. Endovascular rescue strategies for nonopening of Pipeline device: report of two cases. Asian J Neurosurg. 2019;14(4):1240\u20131244."},{"issue":"2","key":"b28","series-title":"J Neurointerv Surg","first-page":"188","article-title":"Use of Pipeline Flex is associated with reduced fluoroscopy time, procedure time, and technical failure compared with the first-generation Pipeline embolization device","volume":"9","author":"Le EJ","year":"2017","unstructured":"Le EJ, Miller T, Serulle Y, Shivashankar R, Jindal G, Gandhi D. Use of Pipeline Flex is associated with reduced fluoroscopy time, procedure time, and technical failure compared with the first-generation Pipeline embolization device. J Neurointerv Surg. 2017;9(2):188\u2013191."},{"issue":"4","key":"b29","series-title":"AJNR Am J Neuroradiol","first-page":"474","article-title":"The FRESH Study: treatment of intracranial aneurysms with the new FRED X flow diverter with antithrombotic surface treatment technology-first multicenter experience in 161 patients","volume":"44","author":"Vollherbst DF","year":"2023","unstructured":"Vollherbst DF, L\u00fccking H, DuPlessis J,  The FRESH Study: treatment of intracranial aneurysms with the new FRED X flow diverter with antithrombotic surface treatment technology-first multicenter experience in 161 patients. 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Stroke. 2001;32(9):1998\u20132004."},{"issue":"5","key":"b33","series-title":"Stroke","first-page":"604","article-title":"Interobserver agreement for the assessment of handicap in stroke patients","volume":"19","author":"Van Swieten JC","year":"1988","unstructured":"Van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. 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