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(Stroke. 2008;39:2860.)
© 2008 American Heart Association, Inc.

Original Contributions

A Novel Endovascular Device for Emboli Rerouting

Part I: Evaluation in a Swine Model

Ygael Grad, PhD; Horst Sievert, MD; Boaz Nishri, PhD; Gregg W. Stone, MD; Barry T. Katzen, MD; Ofer Yodfat, MD; Randall Higashida, MD; Dagan Harris, PhD; Ajay K. Wakhloo, MD; Yaron Assaf, MD; Alexander Norbash, MD; Doron Bushi, MSc Baruch B. Lieber, PhD

From the CardioVascular Center Frankfurt (H.S.), Sankt Katharinen, Frankfurt, Germany; the Faculty of Engineering (Y.G.), Tel-Aviv University, Tel-Aviv, Israel; MindGuard Ltd (Y.G., B.N., O.Y., D.H., Y.A., D.B.), Caesarea, Israel; Columbia University Medical Center (G.W.S.), New York, NY; Miami Cardiac & Vascular Institute (B.T.K.), Baptist Hospital, Miami, Fla; the University of California (R.H.), San Francisco Medical Center, San Francisco, Calif; the School of Medicine (A.K.W.) and Biomedical Engineering (B.B.L.), University of Miami, Miami, Fla; and Boston University Medical Center (A.N.), Boston, Mass.

Correspondence to Ygael Grad, PhD, 14 Mintz Street, Tel-Aviv 69512, Israel. E-mail ygael{at}eng.tau.ac.il

Background and Purpose— The feasibility and safety of a novel endovascularly delivered tubular mesh designed to reroute emboli away from a critical artery as a means of ischemic stroke prevention was tested in vitro and in vivo.

Methods— Emboli rerouting efficacy was assessed in vitro. Perfusion through the external femoral artery that was jailed by the device, cellular proliferation rate over the jailing mesh, and the resulting tissue coverage of the orifice were assessed in the swine iliofemoral bifurcation. Device-induced embolization was assessed in a swine kidney model.

Results— In vitro experiments demonstrated that particles as small as 60% of the pore dimension can be rerouted by the device, although at low efficacy, and rerouting efficacy approached 100% as the particle size approached the pore dimension. Repeat assessment of flow preimplantation and at various follow-up times by Doppler ultrasound showed no significant changes in the perfusion ratio of the jailed branch to the parent artery or the jailed branch to the naive contralateral artery either as a result of device implantation or at the follow-up times. Tissue coverage over the jailed ostium was limited to approximately 12% after stabilization. Cellular proliferation rate gradually decreased to diminishing level approximately 22 weeks postimplantation. The devices implanted across the renal arteries did not demonstrate any device-induced embolization after 1 month.

Conclusions— It is proposed that this device could be used to reroute emboli away from important intracranial vessels as a means of stroke prevention.

Key Words: carotid arteries • embolism • hemodynamics • prevention • stroke

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