FRED™ Flow Diverter

SAFE: Safety and Efficacy Analysis of FRED™ Embolic Device in Aneurysm Treatment

"SAFE study analysis at 1 year confirms the excellent safety profile of the FRED™ device for aneurysm treatment, with low morbidity and mortality rates (2.9% and 1.9%, respectively) and demonstrates its efficacy (adequate occlusion in 73/90 (81.1%)."

Patients: 103
Country: France
Clinical Centers: 13
Design: Single arm prospective
Scope: Patients ≥ 18 y.o. with a non acutely ruptured or recanalized IC aneurysm, on the anterior circulation, requiring endovascular treatment, mRS ≤ 2, eligible to be treated with FRED™ /FRED™ Jr in French centers.
Purpose: Assess Safety and Efficacy of FRED™ / FRED™ Jr devices in Aneurysm Treatment to obtain reimbursement in France.

Endpoints

Efficacy: Aneurysm complete occlusion without ˃ 50% parent artery stenosis at 6 months (assessed by Corelab)

Safety: Morbidity & Mortality rate at 6 months, defined as an mRS > 2

Efficacy results

Treatment success: 95.1%

At 6 months:

Complete occlusion: 61.1%
No parent artery stenosis or <50%: 92.6%

At 12 months:

Complete occlusion: 73.3 %
No parent artery stenosis or <50%: 93.3%
Retreatment rate: 2.2%

Safety results

At 6 months:

Morbidity: 2%
Mortality: 1%
Thromboembolic (TE) complications: 4.9%

At 12 months:

Morbidity: 2.9% (incl. 1 intraoperative TE, 1 Long term TE, 1 delayed aneurysm rupture)
Mortality: 1.9% (incl. 1 dissection during catheterization and 1 cancer)
Thromboembolic complications: 6.8%

Study publications

LINK TO STUDY PAGE ClinicalTrials.gov ID NCT02921698

Please refer to IFU for the full list of risks, contraindications, warnings, and precautions.

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