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Original research
Preclinical evaluation of Millipede 088 intracranial aspiration catheter in cadaver and in vitro thrombectomy models
  1. Seán Fitzgerald1,
  2. David Ryan2,
  3. John Thornton3,
  4. Raul G Nogueira4,5
  1. 1Department of Physiology, National University of Ireland Galway, Galway, Ireland
  2. 2Department of Mechanical Engineering, National University of Ireland Galway, Galway, Ireland
  3. 3Interventional Neuroradiology Service, Department of Radiology, Beaumont Hospital, Dublin, Ireland
  4. 4Marcus Stroke & Neuroscience Center, Grady Memorial Hospital, Atlanta, Georgia, USA
  5. 5Department of Neurology, Emory University, Atlanta, Georgia, USA
  1. Correspondence to Dr Seán Fitzgerald, Physiology, National University of Ireland Galway, Galway H91 TK33, Ireland; sean.fitzgerald{at}nuigalway.ie

Abstract

Background Larger bore aspiration catheters are expected to significantly improve the speed and completeness of acute stroke revascularization.

Objective To evaluate the navigability and clot retrieval performance of a novel 8Fr aspiration catheter, Millipede 088 (Perfuze Ltd), using fresh-frozen cadavers and an in vitro thrombectomy model, respectively.

Methods Cadaveric study: Transfemoral catheterization of the intracranial arteries was performed in six cadavers, allowing evaluation of navigation to 12 middle cerebral arteries (MCAs) and six basilar arteries. Commercially available 6Fr aspiration catheters (SOFIA Plus, Microvention) were used as controls. In vitro study: Three human blood clot phenotypes were created; red blood cell-rich, mixed, and fibrin/platelets-rich. Two clot sizes, resulting in occlusion of the internal carotid artery (ICA) and MCA-M1 were investigated. Endpoints were first-pass effect (FPE), first-pass complete ingestion, and second-pass recanalization.

Results Cadaveric study: Both the Millipede 088 and SOFIA Plus devices reached the distal MCA-M1 and the basilar artery in 10/12 and 2/2 of the navigation attempts, respectively. In the two instances of unsuccessful navigation, neither device was able to cross the ophthalmic artery. In vitro study: In 10 mm long M1 occlusions, Millipede 088 achieved 100% FPE versus 40% for 6Fr devices (p>0.001). In 20 mm long ICA occlusions, Millipede 088 achieved 100% removal success within two passes in each clot phenotype compared with an average of 27% for 6Fr devices (p>0.001).

Conclusions Navigation of the Millipede 088 catheter to the MCA-M1 and basilar artery is feasible in a cadaver model. Millipede 088 demonstrates superiority over 6Fr aspiration catheters for three representative clot phenotypes at the most common sites of occlusion in an in vitro vasculature model.

  • navigation
  • technique
  • thrombectomy
  • stroke
  • device
http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Twitter @FitzSeanT

  • Contributors SF: study design, performing experiments, data analysis, and drafting the manuscript. DR: performing in vitro experiments and data analysis. JT: study design, data analysis, and drafting the manuscript. RN: study design, performing the cadaveric testing, data analysis, and drafting the manuscript.

  • Funding This work was supported by the European Regional Development Enterprise Ireland grant number IP-2019–0865.

  • Competing interests SF received research funding from Enterprise Ireland that is co-funded by Perfuze Ltd. JT declares the following competing interests: Perfuze (physician advisory board, stock options); Microvention (consultant - moderate); Johnson and Johnsons (consultant - moderate). RN declares the following competing interests; Stryker Neurovascular (DAWN Trial principal investigator - no compensation, TREVO Registry steering committee - no compensation; consultant - significant); Cerenovus/Neuravi (ENDOLOW Trial principal investigator - no compensation, EXCELLENT Registry principal investigator - no compensation, ARISE-2 Trial steering committee - no compensation, physician advisory board - modest); Phenox (PROST Trial principal investigator, physician advisory board - modest); Anaconda (physician advisory board - modest); Genentech (physician advisory board - modest); Perfuze (physician advisory board - stock options); Biogen (CHARM Trial steering committee; physician advisory board - modest); Prolong Pharmaceuticals (physician advisory board - modest); Brainomix (physician advisory board - stock options); Viz-AI (physician advisory board - stock options); Corindus Vascular Robotics (physician advisory board - stock options); Vesalio (physician advisory board - stock options); Ceretrieve (physician advisory board - stock options); Astrocyte (physician advisory board - stock options); Cerebrotech (physician advisory board - stock options); Imperative Care (Imperative Trial principal investigator - modest).

  • Patient consent for publication Not required.

  • Ethics approval The cadaveric work was approved by the Medical Education & Research Institute (MERI) (Study Numbers 19–1311-ME & 19–0828-ME) accredited by the American Association of Tissue Banks (AATB). Ethical approval for the In-vitro study was granted by the National University of Ireland Research Ethics committee (19-DEC-11).

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

  • Data availability statement All data are available upon reasonable request to the corresponding author.

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