title: FRED Flow Diverter: A Study on Safety and Efficacy in a Consecutive Group of 50 Patients.
abstract: Endovascular flow diverters are increasingly used for the treatment of cerebral aneurysms. We assessed the safety and efficacy of the Flow-Redirection Endoluminal Device (FRED) in a consecutive series of 50 patients.
  
  
  
  Inclusion criteria were wide-neck, blister-like, or fusiform/dissecting aneurysms independent of size, treated with the FRED between February 2014 and May 2015. Assessment criteria were aneurysm occlusion, manifest ischemic stroke, bleeding, or death. The occlusion rate was assessed at 3 months with flat panel CT and at 6 months with DSA by using the Raymond classification and the O'Kelly-Marotta grading scale.
  
  
  
  Fifty patients with 52 aneurysms were treated with 54 FREDs; 20 patients were treated with the FRED and coils. Aneurysm size ranged from 2.0 to 18.5 mm. Deployment of the FRED was successful in all cases. There were no device-associated complications. One patient developed mild stroke symptoms that fully receded within days. There have been no late-term complications so far and no treatment-related mortality. Initial follow-up at 3 months showed complete occlusion in 72.3% of the overall study group, Six-month follow-up showed total and remnant-neck occlusion in 87.2% of patients, distributed over 81.5% of the FRED-only cases and 95.0% of the cases with combined treatment.
  
  
  
  The FRED flow diverter is a safe device for the treatment of cerebral aneurysms of various types. Our data reveal high occlusion rates at 3 and 6 months, comparable with those in other flow diverters. Long-term occlusion rates are expected.
authors.affiliation: From the Departments of Neuroradiology (H.L., T.E., S.L., P.G., S.K., A.D.) hannes.luecking@uk-erlangen.de.
authors.forename: H
authors.identifier: 0000-0002-3935-0003
authors.initials: H
authors.lastname: Luecking
authors.affiliation: From the Departments of Neuroradiology (H.L., T.E., S.L., P.G., S.K., A.D.).
authors.forename: T
authors.identifier: 0000-0001-7341-3584
authors.initials: T
authors.lastname: Engelhorn
authors.affiliation: From the Departments of Neuroradiology (H.L., T.E., S.L., P.G., S.K., A.D.).
authors.forename: S
authors.identifier: 0000-0003-2426-4644
authors.initials: S
authors.lastname: Lang
authors.affiliation: From the Departments of Neuroradiology (H.L., T.E., S.L., P.G., S.K., A.D.).
authors.forename: P
authors.identifier: 0000-0002-7988-7331
authors.initials: P
authors.lastname: Goelitz
authors.affiliation: From the Departments of Neuroradiology (H.L., T.E., S.L., P.G., S.K., A.D.).
authors.forename: S
authors.identifier: 0000-0002-1331-8400
authors.initials: S
authors.lastname: Kloska
authors.affiliation: Neurosurgery (K.R.), University of Erlangen-Nuremberg, Erlangen, Germany.
authors.forename: K
authors.identifier: 0000-0001-5339-5112
authors.initials: K
authors.lastname: Roessler
authors.affiliation: From the Departments of Neuroradiology (H.L., T.E., S.L., P.G., S.K., A.D.).
authors.forename: A
authors.identifier: 0000-0002-3076-3231
authors.initials: A
authors.lastname: Doerfler
mesh_terms: D000328:Adult; D000368:Aged; D001807:Blood Vessel Prosthesis / Q000009:adverse effects; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D002545:Brain Ischemia / Q000000981:diagnostic imaging / Q000601:surgery; D002533:Cerebral Angiography; D057510:Endovascular Procedures / Q000295:instrumentation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D002532:Intracranial Aneurysm / Q000000981:diagnostic imaging / Q000601:surgery*; D018810:Magnetic Resonance Angiography; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D020521:Stroke / Q000000981:diagnostic imaging / Q000601:surgery; D016896:Treatment Outcome