FRED EPI Study:
FRED™ and FRED™ Jr Devices for Intracranial Aneurysm Treatment
FRED™ Flow Diverter
"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 Instruction for Use (IFU) in the specific market/country that you are looking into:
Explore more studies
Poland Study: The evaluation of the flow re-direction endoluminal device (FRED™) for the treatment of selected intracranial aneurysms: a Polish multicenter study
FRED™ Flow Diverter
UK Study: Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment
FRED™ Flow Diverter
Request more information
The information you provide through this form is necessary to respond to your request and may be shared with the relevant Terumo Neuro group entity or entities responsible for handling it. For more information on how we process your personal data and on your rights, please refer to our privacy policy.