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The Lazarus Funnel: a blinded prospective randomized in vitro trial of a novel CE-marked thrombectomy assist device
  1. Kyle M Fargen1,
  2. J Mocco2,
  3. Y Pierre Gobin3
  1. 1Department of Neurosurgery, University of Florida, Gainesville, Florida, USA
  2. 2Department of Neurosurgery, Vanderbilt University, Nashville, Tennessee, USA
  3. 3Department of Neurosurgery, Weill Cornell Medical College, New York, New York, USA
  1. Correspondence to Dr Kyle M Fargen, Department of Neurosurgery, University of Florida, Box 100265, Gainesville, FL 32610, USA; kyle.fargen{at}neurosurgery.ufl.edu

Abstract

Introduction The use of retrievable stents for acute ischemic stroke (AIS) may result in the release of distal emboli in 12–22% of cases. The Lazarus Funnel is a novel CE-marked thrombectomy assist device designed to capture the stentriever and thrombus to minimize the likelihood of distal embolization. To study this technology, we performed a randomized blinded in vitro evaluation of this device.

Methods A cerebral flow model was used as an in vitro simulator for cerebral arterial thrombectomy procedures. Stratified block randomization was performed following embolus injection into one of three cohorts: Solitaire stentriever plus guide catheter (control); control plus proximal Funnel placement; or control plus distal Funnel placement. Time to embolectomy, recanalization, and incidence of distal emboli were determined by a blinded observer.

Results Forty-five thrombectomy trials were performed (15 in each group). The average time required for thrombectomy in each group was 8 min 26 s, 11 min 0 s and 9 min 24 s, respectively (p=NS). Use of the Funnel was associated with significantly improved recanalization compared with stentriever alone (p<0.01). Use of the proximal Funnel resulted in a 25% increase in successful recanalization and a 20% reduction in distal emboli. Use of the distal Funnel resulted in a 200% increase in successful recanalization and a 60% reduction in emboli.

Conclusions In this AIS embolism flow model with Solitaire thrombectomy, the Lazarus Funnel resulted in a significant increase in recanalization and significant reduction in distal emboli without increase in time to recanalization.

  • Device
  • Embolic
  • Intervention
  • Stroke
  • Thrombectomy

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