Letter: Safety and Efficacy of the Off-Label Use of Pipeline Embolization Device Based on the 2018 Food and Drug Administration-Approved Indications for Intracranial Aneurysms: A Single-Center Retrospective Cohort Study

Samuel J Cler¹, David C Lauzier², Akash P Kansagra^{1

2

3

4}

Affiliations

¹ Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, Missouri, USA.
² Department of Neurological Surgery, Washington University School of Medicine, St. Louis, Missouri, USA.
³ Department of Neurology, Washington University School of Medicine, St. Louis, Missouri, USA.
⁴ Department of Neurointerventional Surgery,California Center for Neurointerventional Surgery, San Diego, California, USA.

Comment

Samuel J Cler et al. Neurosurgery. 2022.

. 2022 Nov 1;91(5):e135.

doi: 10.1227/neu.0000000000002125. Epub 2022 Aug 24.

Samuel J Cler¹, David C Lauzier², Akash P Kansagra^{1

2

3

4}

¹ Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, Missouri, USA.
² Department of Neurological Surgery, Washington University School of Medicine, St. Louis, Missouri, USA.
³ Department of Neurology, Washington University School of Medicine, St. Louis, Missouri, USA.
⁴ Department of Neurointerventional Surgery,California Center for Neurointerventional Surgery, San Diego, California, USA.

No abstract available

Comment in

In Reply: Safety and Efficacy of the Off-Label Use of Pipeline Embolization Device Based on the 2018 Food and Drug Administration-Approved Indications for Intracranial Aneurysms: A Single-Center Retrospective Cohort Study.
Enriquez-Marulanda A, Penumaka A, Ogilvy CS, Thomas AJ, Moore JM. Enriquez-Marulanda A, et al. Neurosurgery. 2022 Nov 1;91(5):e136. doi: 10.1227/neu.0000000000002126. Epub 2022 Sep 2. Neurosurgery. 2022. PMID: 36053078 No abstract available.

Safety and Efficacy of the Off-Label Use of Pipeline Embolization Device Based on the 2018 Food and Drug Administration-Approved Indications for Intracranial Aneurysms: A Single-Center Retrospective Cohort Study.
Enriquez-Marulanda A, Penumaka A, Ogilvy CS, Thomas AJ, Moore JM. Enriquez-Marulanda A, et al. Neurosurgery. 2022 Jun 1;90(6):700-707. doi: 10.1227/neu.0000000000001891. Epub 2022 Mar 25. Neurosurgery. 2022. PMID: 35319533

1. Becske T, Kallmes DF, Saatci I, et al. Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial. Radiology. 2013;267(3):858-868.
1. United States Food and Administration. Label Change Premarket Approval for the Pipeline Flex Embolization Device; 2018. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100...
1. Cler SJ, Lauzier DC, Chatterjee AR, Osbun JW, Moran CJ, Kansagra AP. Comparative study of on-label versus off-label treatment of intracranial aneurysms with the Pipeline embolization device. J Neurosurg. Published online ahead of print January 28, 2022. DOI: 10.3171/2021.11.JNS212481. - DOI
1. Enriquez-Marulanda A, Penumaka A, Ogilvy CS, Thomas AJ, Moore JM. Safety and efficacy of the off-label use of pipeline embolization device based on the 2018 Food and Drug Administration-approved indications for intracranial aneurysms: a single-center retrospective cohort study. Neurosurgery. 2022;90(6):700-707.
1. Hanel RA, Cortez GM, Lopes DK, et al. Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification. J Neurointerv Surg. Published online ahead of print March 15, 2022. DOI: 10.1136/neurintsurg-2021-018501. - DOI