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Related Experiment Videos

The Pennsylvania Postmarket Multicenter Experience With Flow Redirection Endoluminal Device.

Mohamed M Salem1, Svetlana Kvint1, Philipp Hendrix2

  • 1Department of Neurosurgery, Hospital of the University of Pennsylvania, Penn Medicine, Philadelphia, Pennsylvania, USA.

Neurosurgery
|April 8, 2022
PubMed
Summary

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Early US data show the flow redirection endoluminal device (FRED) is safe and effective for treating brain aneurysms. Further studies are needed to confirm long-term safety and durability.

Area of Science:

  • Neurosurgery
  • Interventional Radiology
  • Medical Devices

Background:

  • The flow redirection endoluminal device (FRED) is a novel, FDA-approved nitinol braided flow diverter.
  • Limited early postmarket data exist for the FRED device in the United States.

Purpose of the Study:

  • To report the short-term, multicenter clinical experience with the FRED device for intracranial aneurysms.
  • To evaluate the safety and efficacy of the FRED device in a real-world setting.

Main Methods:

  • A retrospective analysis of consecutive patients treated with FRED for intracranial aneurysms across four North American centers.
  • Data collected included baseline demographics, aneurysm characteristics, procedural details, and outcomes (occlusion, safety, complications).

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Main Results:

  • 61 patients underwent 65 procedures for 72 aneurysms; 86.1% were unruptured.
  • Complete or near-complete aneurysm occlusion was achieved in 85.5% of cases at a median of 6.3 months.
  • Permanent ischemic complications occurred in 2.8% of cases, with no procedural mortality. 98.1% of patients had a modified Rankin Scale score of 0-2.

Conclusions:

  • The FRED device demonstrates reasonable safety and adequate aneurysm occlusion rates in early postmarket use, comparable to other flow diverters.
  • Extended multicenter studies with longer follow-up are necessary to fully assess the long-term safety and durability of the FRED device.