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J Neurol Surg A Cent Eur Neurosurg
DOI: 10.1055/a-2697-4429
Original Article

The New Surface-Modified Flow Diverter p48 MW HPC Device Implanted in Arteries under 2.0 mm Diameter for Treatment of Distal Intracranial Aneurysms

Autoren

  • Pedro Lucas Moreira Fernandes

    1   Department of Interventional Neuroradiology, Universidade de São Paulo Faculdade de Medicina de Ribeirão Preto, Ribeirao Preto, São Paulo, Brazil

  • Luis H. de Castro-Afonso 

    1   Department of Interventional Neuroradiology, Universidade de São Paulo Faculdade de Medicina de Ribeirão Preto, Ribeirao Preto, São Paulo, Brazil
    2   Department of Neurosciences and Behaviour Sciences, University of São Paulo, Interventional Neuroradiology, Avenida Bandeirantes, Ribeirao Preto, Brazil

  • Guilherme Seizem Nakiri

    1   Department of Interventional Neuroradiology, Universidade de São Paulo Faculdade de Medicina de Ribeirão Preto, Ribeirao Preto, São Paulo, Brazil

  • Ricardo Santos de Oliveira

    1   Department of Interventional Neuroradiology, Universidade de São Paulo Faculdade de Medicina de Ribeirão Preto, Ribeirao Preto, São Paulo, Brazil

  • Benedicto Oscar Colli

    3   Division of Neurosurgery, USP HCFMRP, Ribeirao Preto, São Paulo, Brazil

  • Daniel Giansante Abud

    1   Department of Interventional Neuroradiology, Universidade de São Paulo Faculdade de Medicina de Ribeirão Preto, Ribeirao Preto, São Paulo, Brazil

Funding Information The entire study was conducted in the context of clinical care practice of our Institution. The manufacturer (Wallaby-phenox, Bochum, Germany) supported the study providing all devices p48 MW HPC, prasugrel and VerifyNow tests used in this study. However, the phenox did not participate in any data collection, management, analysis, interpretation, or reporting results. The phenox did not have any authority regarding the decision to publish the results obtained by the coordination center. The coordination center was the sole responsible for all data collection, register, analysis, interpretation, and publication of the manuscript.
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Abstract

Introduction

Preliminary studies on the new modified surface flow diverters (FD) have shown promising results in the treatment of distal aneurysms. However, there is a lack of data in the literature regarding the use of these devices in very small-caliber arteries. The aim of this study was to analyze the safety and efficacy of the p48 MW HPC device (Wallaby-phenox, Bochum, Germany) device in the treatment of intracranial aneurysms associated with parent arteries with a diameter of <2.0 mm.

Methods

Sixteen patients were prospectively evaluated from November 2019 to July 2023. All patients underwent follow-ups at 1, 6, and 12 months. Safety was assessed using the modified Rankin Scale and the National Institutes of Health Stroke Scale. Efficacy was defined as complete (grade D) or partial (grade C) aneurysm occlusion, as assessed by the O'Kelly–Marotta scale (OKM).

Results

The mean proximal and distal artery diameters were 1.61 mm (1.3–1.9) and 1.5 mm (1.0–1.8), respectively. All procedures were performed with technical success, and no severe adverse events occurred. At the 12-month follow-up, no patients experienced serious adverse events, new neurological symptoms, or deficits. At this stage, seven aneurysms were completely occluded (OKM grade D: 43.7%), and four aneurysms showed entry remnant contrast (OKM grade C: 25%).

Conclusions

The treatment of distal unruptured aneurysms with the p48 MW HPC device device appears to be safe in vessels with a diameter of <2 mm. Larger studies with long-term follow-ups are necessary to better clarify the outcomes reported.

Keywords

flow diverter - distal intracranial aneurysms - small vessels

Data Availability Statement

Unpublished or unprocessed data, protocols, or images are available upon request from the corresponding author.




Publikationsverlauf

Eingereicht: 25. Februar 2025

Angenommen: 05. September 2025

Artikel online veröffentlicht:
13. November 2025

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