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Original research
A novel self-expanding primarily bioabsorbable braided flow-diverting stent for aneurysms: initial safety results
  1. Mehdi Jamshidi1,
  2. Mahmoud Rajabian2,
  3. Michael B Avery3,
  4. Uttandaraman Sundararaj4,
  5. Janet Ronsky5,
  6. Brooke Belanger6,
  7. John H Wong6,
  8. Alim P Mitha1,6
  1. 1 Biomedical Engineering, University of Calgary Schulich School of Engineering, Calgary, Alberta, Canada
  2. 2 MIF Microscopy and Imaging Facility Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada
  3. 3 Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada
  4. 4 Chemical and Petroleum Engineering, University of Calgary, Calgary, Alberta, Canada
  5. 5 Mechanical and Manufacturing Engineering, University of Calgary, Calgary, Alberta, Canada
  6. 6 Clinical Neurosciences, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada
  1. Correspondence to Dr Alim P Mitha, Clinical Neurosciences, University of Calgary Cumming School of Medicine, Calgary, AB T2N 1N4, Canada; amitha{at}ucalgary.ca

Abstract

Introduction The advent of metal flow-diverting stents has provided neurointerventionalists with an option for treating aneurysms without requiring manipulations within the aneurysm sac. The large amount of metal in these stents, however, can lead to early and late thrombotic complications, and thus requires long-term antiplatelet agents. Bioabsorbable stents have been postulated to mitigate the risk of these complications. Here we present early data on the first self-expandable primarily bioabsorbable stent for aneurysms.

Methods Braided stents were developed using poly-L-lactic acid fibers with material surface area similar to metal flow diverters. Crush resistance force, hemolysis, and thrombogenicity were determined and compared with existing commercial devices. Stents were deployed in infra-renal rabbit aortas to determine angiographic side branch patency and to study neointima formation for a 1-month follow-up period.

Results Crush resistance force was determined to be on the order of existing commercial devices. Hemolytic behavior was similar to existing metal devices, and thrombogenicity was lower than metal flow-diverting stents. A smooth neointimal layer was found over the absorbable stent surface and all covered side branches were patent at follow-up.

Conclusion The design of self-expanding primarily bioabsorbable flow-diverting stents is possible, and preliminary safety data is consistent with a favorable profile in terms of mechanical behavior, hemocompatibility, side branch patency, and histological effects. Additional in vitro and long-term in vivo studies are in progress and will help determine aneurysm occlusion rates and absorption characteristics of the stent.

  • aneurysm
  • artery
  • blood flow
  • flow diverter
  • stent

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Footnotes

  • Contributors MJ was responsible for conception and design, acquisition, analysis, interpretation of data, drafting, revising, and final approval of the work. MR was responsible for design, acquisition, analysis, interpretation of data, drafting, revising, and final approval of the work. MBA was responsible for analysis, interpretation of data, drafting, revising, and final approval of the work. US was responsible for design, analysis, interpretation of data, revising, and final approval of the work. JLR was responsible for design, analysis, interpretation of data, revising, and final approval of the work. BLB was responsible for interpretation of data, revising, and final approval of the work. JHW was responsible for conception, analysis, interpretation of data, revising, and final approval of the work. APM was responsible for conception and design, acquisition, analysis, interpretation of data, drafting, revising, and final approval of the work. All authors 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.

  • Funding US was funded by a Natural Sciences and Engineering Research Council of Canada Discovery Grant #05503-2015.

  • Competing interests APM, JHW, and MJ are listed as inventors on patents related to technology described in this article. APM and JHW are founders and shareholders of Fluid Biotech Inc., to which the patents related to technology described in this article are assigned.

  • Patient consent for publication Not required.

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

  • Data availability statement Data are available upon reasonable request.

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