The study assesses the safety and effectiveness of the Flow Direction Endoluminal Device (FRED) for treating selected unruptured intracranial aneurysms through data collected from multiple Polish medical centers.
This Polish multicenter study highlights the potential of the Flow Direction Endoluminal Device (FRED) for treating unruptured intracranial aneurysms, showcasing encouraging results from research spanning multiple medical institutions.
The Polish multicenter study evaluated the FRED device on 86 patients with 89 unruptured intracranial aneurysms, reporting on treatment effectiveness and safety over 24 months.
The study was conducted by multiple interventional neuroradiology centers across Poland, funded by MicroVention Europe.
The study was conducted from January 2016 to September 2017.
Eight investigational sites were involved, all located within Poland.
The research aims to address the need for effective treatment options for unruptured intracranial aneurysms, which are prevalent and pose significant health risks.
The effectiveness of the FRED device was assessed through imaging results evaluated by independent neurologists at six, twelve, and twenty-four months post-treatment.
Safety results indicated a 3.6% rate of permanent neurological morbidity and 2.4% neurological mortality after 24 months.
These results indicate the FRED stent system is safe and effective...
The overall safety profile of the FRED device... is satisfactory.
The article will capture the reader's attention by highlighting the significance of treating unruptured intracranial aneurysms and the promise of the FRED device as demonstrated by this rigorous study.
Explanation of unruptured intracranial aneurysms, existing treatment methods, and the rationale for introducing the FRED device as a new option.
Detailed description of the multicenter study design, patient inclusion criteria, and the use of imaging to evaluate treatment outcomes.
Presentation of the study’s effectiveness results, emphasizing the occlusion rates and low morbidity and mortality, affirming the FRED device's reliability.
Summary of key findings and comments on potential future research areas or questions relating to the FRED device's use.