The Lazarus Funnel: a blinded prospective randomized in vitro trial of a novel CE-marked thrombectomy assist device

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 8min 26s, 11min 0s and 9min 24s, 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.