FRED™ Flow Diverter
FRED EPI: FRED™ and FRED™ Jr Devices for Intracranial Aneurysm Treatment
"FRED-EPI confirms good safety of aneurysm treatment with FRED™/FRED™ Jr in current clinical practice with 4.4% 1-year morbimortality."
- Patients
135
- Country
France
- Clinical Centers
13
- Design
Single arm prospective
- Scope
All patients with an intracranial aneurysm treated with the FRED™ or FRED™ Jr device in France.
- Purpose
To evaluate the morbidity and mortality of patients with intracranial aneurysms treated with the FRED™/FRED™ Jr device in a routine practice post-reimbursement in France.
Endpoints
Morbidity–mortality rate defined as neurologic death or major ipsilateral stroke (hemorrhagic or ischemic) within 1 year of treatment.
Efficacy results
Treatment success: 100%
Complete occlusion at 16 months: 75.5%
Retreatment rate: 1.9% of aneurysms
Safety results
Primary safety endpoint (morbi-mortality at 16 months): 4.4%
LINK TO STUDY PAGE: Clinical Trials.gov ID NCT03423290
Please refer to IFU for the full list of risks, contraindications, warnings, and precautions.
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