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New devices and techniques
Original research
United States regulatory approval of medical devices used for endovascular neurosurgery: A two-decade review of FDA regulatory files
  1. Lokeshwar S Bhenderu1,2,3,
  2. Trevor Hardigan4,
  3. Jorge Roa4,
  4. Brandon D Philbrick4,
  5. Alex Hoang1,3,
  6. Amir H Faraji1,2,3,
  7. Gavin W Britz1,3,
  8. Kurt A Yaeger1,2,3
  1. 1Department of Neurological Surgery, Houston Methodist Hospital, Houston, Texas, USA
  2. 2Clinical Innovations Laboratory, Houston Methodist Research Institute, Houston, Texas, USA
  3. 3Center for Translational Neural Prosthetics and Interfaces, Houston Methodist Research Institute, Houston, Texas, USA
  4. 4Department of Neurological Surgery, Icahn School of Medicine at Mount Sinai Hospital, New York, New York, USA
  1. Correspondence to Lokeshwar S Bhenderu, Department of Neurological Surgery, Houston Methodist Hospital, Houston, Texas, USA; lokeshwar.bhenderu{at}gmail.com

Abstract

Background The evolution of neuroendovascular technologies has progressed substantially. Over the last two decades, the introduction of new endovascular devices has facilitated treatment for more patients, and as a result, the regulatory environment concerning neuroendovascular devices has evolved rapidly in response.

Objective To examine trends in the approval of neuroendovascular devices by the United States Food and Drug Administration (FDA) over the last 20 years.

Methods Open-access US FDA databases were queried between January 2000 and December 2022 for all devices approved by the Neurological Devices Advisory Committee. Neuroendovascular devices were manually classified and grouped by category. Device approval data, including approval times, approval pathway, and presence of predicate devices, were examined.

Results A total of 3186 neurological devices were approved via various US FDA pathways during the study period. 320 (10.0%) corresponded to neuroendovascular devices, of which 301 (94.1%) were approved via the 510(k) pathway. The percentage of 510(k) pathway neuroendovascular devices increased from 6.9% to 14.3% of all neuro devices before and after 2015, respectively. There was an increase in approval times for neuroendovascular devices cleared after 2015.

Conclusion Over the last two decades, the neuroendovascular device armamentarium has rapidly expanded, especially after positive stroke trials in 2015. Regulatory approval times are significantly affected by device category, generation, company size, and company location, and a vast majority are approved by the 510(k) pathway. These results can guide further innovation in the endovascular device space and may act as a roadmap for future regulatory planning.

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Data availability statement

Data are available upon reasonable request. Not applicable.

http://dx.doi.org/10.1136/jnis-2023-020703

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    Data availability statement

    Data are available upon reasonable request. Not applicable.

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    Footnotes

    • Twitter @bhenderu

    • Contributors LSB, KAY: conceptualization, formal analysis, writing - original draft, writing - review and editing. TH, JR, BDP: conceptualization, writing - review and editing. AH, AHF, GWB: supervision, writing - review and editing. LSB is the guarantor for this work.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

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

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.