FRED™ Flow Diverter

UK: Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment

"The FRED™ and FRED™ Jr devices are safe and efficacious in the treatment of intracranial aneurysms."

Patients

Country

Clinical Centers

Design

Single arm prospective

Scope

Patients ≥18 y.o. presenting with an unruptured or recanalized IC aneurysm, from anterior circulation, requiring endovascular treatment, mRS≤2, eligible to be treated with FRED™/FRED™ Jr in UK centers.

Purpose

To demonstrate the use of the FRED™/FRED™ Jr Embolic device in intracranial AN treatment.

To assess the safety and effectiveness when assessed at 1, 6 and 12 months post procedure.

Endpoints

Efficacy:

Complete aneurysm occlusion without stenosis (>50%) of the parent vessel at 6 months, evaluated by Corelab

Safety:

Morbidity (mRS>2) rate at 6 months
Mortality rate at 6 months

Efficacy results

At 6 months:

Primary endpoint: Complete occlusion without associated stenosis of parent artery (>50%): 63.3%

At 12 months:

Adequate occlusion: 86.7%

Safety results

At 6 months and 12 months (FAS population):

Morbidity: 0%
Mortality: 0%

Study publications

FRED-UK: Multicentre UK experience of FRED and FRED Jr flow re-direction endoluminal device for intracranial aneurysms: 6 months and 1 year clinical and anatomical results Taylor E, et al Interv neuroradiol.2024

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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