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Novel Embolic Protection Device: a Feasibility Study

  • Elon Reshef
  • Doron Bushi
  • Udi NussinovitchEmail author
Original Article

Abstract

Stroke is ranked as the second leading cause of death worldwide. Ischemic stroke commonly results from emboli that originate in the heart among high-risk patients, such as those who develop atrial fibrillation. Yet, treatment is currently limited to anticoagulants, which may be associated with life-threatening bleeding. Our aim was to develop an alternative, device-based approach for continuous stroke prevention in high-risk patients. To this end, a novel endovascular tubular mesh was designed to be implanted in the aortic arch and to reroute emboli away from critical cerebral arteries. The feasibility of this approach as a means of ischemic stroke prevention was tested in vitro. The simulated cerebral perfusion pressures were not affected by the device. Also, the device efficiently diverted clinically meaningful embolic particles away from the cerebral circulation. It is proposed that this device could be used to reroute cardio-emboli away from intracranial vessels as a means of stroke prevention among patients for which anticoagulants are contraindicated.

Keywords

Stroke Embolic protection Anticoagulants Left atrial appendage occlusion 

Abbreviations

OACs

Oral anticoagulants

AF

Atrial fibrillation

ICA

Internal carotid artery

LVO

Large vessel occlusions

LAAO

Left atrial appendage occlusion

MCA

Middle cerebral artery

Notes

Acknowledgment

We thank Faye Schreiber for editorial assistance. Also, we wish to thank Ohad Shaplan (Pangolin, Inc.) and Uri Shpolanski (Physiomodels, Inc.) for their help with setting up the experimental systems and data collection, respectively.

Funding

This study was funded by the Israel Innovation Authority.

Compliance with Ethical Standards

Conflict of Interests

The study was conducted by InVatin Technologies, Ltd. InVatin Technologies, Ltd was founded by Udi Nussinovitch, MD, PhD. UN and ER are employees of InVatin Technologies, Ltd. DB is a consultant for InVatin Technologies, Ltd.

Ethical Approval

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

Supplementary material

12265_2019_9920_MOESM1_ESM.mp4 (1.4 mb)
Video 1. Fluoroscopic imaging of embolization of a large number of embolic particles to unprotected simulated cerebral circulation. Notice that a substantial portion of the beads are carried to the simulated cerebral vessels. (MP4 1456 kb)
12265_2019_9920_MOESM2_ESM.mp4 (2.1 mb)
Video 2. Fluoroscopic imaging of radiopaque particles diverted away from the simulated cerebral circulation following implantation of the device. (MP4 2104 kb)

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.InVatin Technologies, Ltd.KatzrinIsrael
  2. 2.Department of Cardiology, and Applicative Cardiovascular Research Center (ACRC)Meir Medical CenterKfar SabaIsrael
  3. 3.Sackler Faculty of MedicineTel Aviv University Tel AvivIsrael

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