FRED™ Flow Diverter

Poland: The evaluation of the flow re-direction endoluminal device (FRED™) for the treatment of selected intracranial aneurysms: a Polish multicenter study

"This study offers a comprehensive overview of the flow diversion treatment approach, demonstrating that the FRED™ device is effective and safe for use in intracranial aneurysm treatment. These results align with existing literature, reaffirming the device reliability and suitability for clinical use."

Patients: 86
Country: Poland
Clinical Centers: 8
Design: Single arm prospective
Scope: Patients 18-80 y.o. with unruptured saccular or fusiform intracranial aneurysms located in the anterior circulation (ICA segments C2–C6) or in the posterior circulation (above the PICA).
Purpose: To evaluate the safety and effectiveness of the FRED™ in the treatment of selected types and location of intracranial aneurysms throughout the complete follow-up period of 24 months.

Endpoints

Effectiveness: Percentage of aneurysms successfully isolated from the rest of the circulation (Grade 4) and patency of the flow-diverter lumen (> 50%: Grade C and D) at 6-, 12- and 24-months of follow-up.

Safety: Rate of clinical complications, including early thromboembolic complications (within the first 3 months), late thromboembolic complications (between 3 and 24 months) and/or hemorrhage from the treated aneurysm, as adjudicated by the Clinical Event Committee.

Efficacy results

At 6 months:

Complete occlusion without parent artery stenosis: 61.8%
Complete occlusion: 64.9%

At 12 months:

Complete occlusion without parent artery stenosis: 76.1%
Complete occlusion: 79.5 %

At 24 months:

Complete occlusion without parent artery stenosis: 82.5%
Complete occlusion: 85.5 %

Safety results

At 24 months:

Clinical complications classified by the CEC as early thromboembolic complication, late thromboembolic complication or hemorrhage from the treated aneurysm: 10.8%
Permanent neurological morbidity: 3.6%
All-cause mortality: 3.6% (including 2.4% of neurological death)

Study publications

The evaluation of the flow redirection endoluminal device (FRED) for the treatment of selected intracranial aneurysms: a Polish multicenter study – Jaworski M, et al. Scientific Reports. 2025; 15:6386

LINK TO STUDY PAGE: PMID: 39984615

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