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Quantitative Characterization of Recanalization and Distal Emboli with a Novel Thrombectomy Device

  • Laboratory Investigation
  • Stroke/Neurointerventions
  • Published:
CardioVascular and Interventional Radiology Aims and scope Submit manuscript

Abstract

Purpose

The first-pass effect during mechanical thrombectomy improves clinical outcomes regardless of first-line treatment approach, but current success rates for complete clot capture with one attempt are still less than 40%. We hypothesize that the ThrombX retriever (ThrombX Medical Inc.) can better engage challenging clot models during retrieval throughout tortuous vasculature in comparison with a standard stent retriever without increasing distal emboli.

Materials and Methods

Thrombectomy testing with the new retriever as compared to the Solitaire stent retriever was simulated in a vascular replica with hard and soft clot analogs to create a challenging occlusive burden. Parameters included analysis of distal emboli generated per clot type, along with the degree of recanalization (complete, partial or none) by retrieval device verified by angiography.

Results

The ThrombX device exhibited significantly higher rates of first-pass efficacy (90%) during hard clot retrieval in comparison with the control device (20%) (p < 0.009), while use of both techniques during soft clot retrieval resulted in equivalent recanalization. The soft clot model generated higher numbers of large emboli (>200 μm) across both device groups (p = 0.0147), and no significant differences in numbers of distal emboli were noted between the ThrombX and Solitaire techniques.

Conclusions

Irrespective of clot composition, use of the ThrombX retriever demonstrated high rates of complete recanalization at first pass in comparison with a state-of-the-art stent retriever and proved to be superior in the hard clot model. Preliminary data suggest that risk of distal embolization associated with the ThrombX system is comparable to that of the control device.

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Funding

This study was funded by a sponsored research contract by ThrombX Medical.

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Authors and Affiliations

  1. Department of Radiology, New England Center for Stroke Research, University of Massachusetts Medical School, 55 Lake Ave N, SA-107R, Worcester, MA, 01655, USA

    Ju-Yu Chueh PhD, Miklos G. Marosfoi MD, Vania Anagnostakou MD, Rose A. Arslanian BS & Matthew J Gounis PhD

  2. Department of Radiology, Stanford University School of Medicine, 730 Welch Rd 1st Fl, Palo Alto, CA, 94304, USA

    Michael P. Marks MD

Authors
  1. Ju-Yu Chueh PhD
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  2. Miklos G. Marosfoi MD
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  3. Vania Anagnostakou MD
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  4. Rose A. Arslanian BS
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  5. Michael P. Marks MD
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  6. Matthew J Gounis PhD
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Corresponding author

Correspondence to Matthew J Gounis PhD.

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Conflict of Interest

Chueh: Fee-for-service consulting for Stryker Neurovascular and InNeuroCo Inc.

Marosfoi: Fee-for-service consulting for Stryker Neurovascular, ThrombX and InNeuroCo Inc.

Anagnostakou: The author declares no conflict of interest.

Arslanian: The author declares no conflict of interest.

Marks: Founder and shareholder in ThrombX.

MJG: Has been a consultant on a fee-per-hour basis for Cerenovus, Imperative Care, Medtronic Neurovascular, Mivi Neurosciences, Phenox, Route 92 Medical, Stryker Neurovascular; holds stock in Imperative Care, InNeuroCo and Neurogami; and has received research support from the National Institutes of Health (NIH), the United States – Israel Binational Science Foundation, Anaconda, Apic Bio, Axovant, Cerenovus, Ceretrieve, Cook Medical, Gentuity, Imperative Care, InNeuroCo, Magneto, Microvention, Medtronic Neurovascular, MIVI Neurosciences, Neuravi, Neurogami, Philips Healthcare, Rapid Medical, Route 92 Medical, Stryker Neurovascular, Syntheon and the Wyss Institute.

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This article does not contain any studies with human participants or animals performed by any of the authors.

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Chueh, JY., Marosfoi, M.G., Anagnostakou, V. et al. Quantitative Characterization of Recanalization and Distal Emboli with a Novel Thrombectomy Device. Cardiovasc Intervent Radiol 44, 318–324 (2021). https://doi.org/10.1007/s00270-020-02683-3

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  • DOI: https://doi.org/10.1007/s00270-020-02683-3

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