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  • Periprocedural outcomes and early safety with the use of the Pipeline Flex Embolization Device with Shield Technology for unruptured intracranial aneurysms: preliminary results from a prospective clinical study

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New devices
Case series
Periprocedural outcomes and early safety with the use of the Pipeline Flex Embolization Device with Shield Technology for unruptured intracranial aneurysms: preliminary results from a prospective clinical study
  1. Mario Martínez-Galdámez1,
  2. Saleh M Lamin2,
  3. Konstantinos G Lagios3,
  4. Thomas Liebig4,
  5. Elisa F Ciceri5,6,
  6. Rene Chapot7,
  7. Luc Stockx8,
  8. Swarupsinh Chavda2,
  9. Christoph Kabbasch4,
  10. Giuseppe Farago5,
  11. Hannes Nordmeyer7,
  12. Thierry Boulanger8,
  13. Mariangela Piano9,
  14. Edoardo P Boccardi9
  1. 1Department of Interventional Neuroradiology/Endovascular Neurosurgery, Fundación Jiménez-Díaz, Madrid, Spain
  2. 2Queen Elizabeth Hospital Birmingham, Edgbaston, UK
  3. 3Department of Interventional Neuroradiology, Hellenic Air Force Hospital, Goudi, Greece
  4. 4Department of Neuroradiology, Institut für Neuroradiologie, Charite, Berlin, Germany
  5. 5Department of Interventional Neuroradiology, Foundation Neurological Institution ‘C Besta’, Milan, Italy
  6. 6Azienda Ospedaliera Universitaria Integrata, Verona, Italy
  7. 7Department of Neuroradiology, Alfried Krupp Krankenhaus, Essen, Germany
  8. 8Department of Neuroradiology, Ziekenhuizen Oost-Limburg, Genk, Belgium
  9. 9Department of Neuroradiology, Ospedale Niguarda Ca’ Granda, Milan, Italy
  1. Correspondence to Dr Mario Martínez-Galdámez, Hospital Universitario Fundación Jiménez Diaz, Avda de los Reyes Católicos, 2, Madrid 28040, Spain; mariomgaldamez{at}hotmail.com

Abstract

Background and purpose The Pipeline Embolization Device (PED) has become a routine first-line option for treatment of intracranial aneurysms (IAs). We assessed the early safety and technical success of a new version of PED, Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield), which has the same design and configuration but has been modified to include a surface synthetic biocompatible polymer.

Materials and methods The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study is a prospective, single-arm, multicenter study for the treatment of unruptured IAs using Pipeline Shield. The primary study endpoints included the occurrence of major stroke in the territory supplied by the treated artery or neurologic death at 1 year post-procedure. Secondary endpoints included the rate of Pipeline Shield-related or procedure-related serious or non-serious adverse events. Analyses were conducted to evaluate early safety findings in the 30-day post-procedure period as well as technical procedural success outcomes.

Results Fifty patients with 50 unruptured target IAs were enrolled. Mean aneurysm diameter was 8.82±6.15 mm. Thirty-eight aneurysms (76%) were small (<10 mm). Device deployment was technically successful with 98% of devices. Complete wall apposition was achieved immediately post-procedure in 48 cases (96%). No major strokes or neurologic deaths were reported in the 30-day post-procedure period.

Conclusions The results of this first experience with the new Pipeline Flex corroborate the early safety of the device. Mid-term and long-term follow-up examinations will provide data on safety outcomes at the 6-month and 1-year follow-up periods.

Clinical trial registration NCT02390037.

  • Aneurysm
  • Flow Diverter
  • Technology

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/neurintsurg-2016-012896

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    Footnotes

    • Funding This work was supported by Medtronic (clinical trial registration NCT02390037).

    • Contributors All authors made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; and drafted the work or revised it critically for important intellectual content; and provided final approval of the version to be published; and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

    • Competing interests MM-G serves as a proctor and consultant for Medtronic. SML receives honoraria from Medtronic in relation to proctoring, speaking, and consulting. TL previously consulted and proctored for Covidien, Stryker, and MicroVention, and currently serves as a proctor and consultant for Sequent Medical. EPB receives honoraria from Medtronic and serves as a consultant for Medtronic.

    • Ethics approval Institutional Review Board.

    • Provenance and peer review Not commissioned; externally peer reviewed.