Experimental evaluation of the NeVa™ thrombectomy device a novel stent retriever conceived to improve efficacy of organized clot removal

Machi, Paolo; Ulm, Arthur J.; Bernava, Gianmarco; Brina, Olivier; Lövblad, Karl-Olof; Jourdan, F

doi:10.1016/j.neurad.2018.03.005

Cited by 11 publications

(6 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Several clinical and experimental studies have evaluated factors related to the failure of MTB17–22 and vessel anatomy has been reported as one of the main factors related to clot removal failure. Zhu et al 13 evaluated the results of patients treated with the Merci retriever device for MCA occlusions.…”

Section: Discussionmentioning

confidence: 99%

Direct thromboaspiration efficacy for mechanical thrombectomy is related to the angle of interaction between the aspiration catheter and the clot

Bernava

Rosi

Boto

et al. 2019

J NeuroIntervent Surg

Self Cite

View full text Add to dashboard Cite

BackgroundDirect thromboaspiration has been reported as an effective mechanical treatment for acute ischemic stroke. We aimed to determine whether the angle of interaction between the aspiration catheter and the clot affects the success of clot removal in ischemic stroke patients with large vessel occlusion in the anterior and posterior circulation.MethodsAll patients treated at our institution by direct thromboaspiration as a firstline technique between January 2016 and December 2017 were enrolled in the study. We retrospectively reviewed baseline and procedural characteristics, the angle of interaction formed between the aspiration catheter and the clot, the modified Thrombolysis in Cerebral Infarction score, and the 3 month modified Rankin Scale score.Results85 patients underwent direct thromboaspiration as the firstline treatment during the study period. 100 direct thromboaspiration passes were performed. An angle of interaction of ≥125.5° significantly influenced the success of clot removal (P<0.001) with good sensitivity and specificity, in particular for occlusion of the middle cerebral and basilar artery. The combination of aspiration with a stent retriever based thrombectomy was a valid rescue treatment in cases of standalone direct thromboaspiration failure.ConclusionsIn our series, an angle of interaction between the aspiration catheter and the clot of ≥125.5° was significantly associated with successful clot removal. The prediction of the angle of interaction on pretreatment imaging may help operators to select the most adequate mechanical thrombectomy technique on a case by case basis.

show abstract

Section: Discussionmentioning

confidence: 99%

Direct thromboaspiration efficacy for mechanical thrombectomy is related to the angle of interaction between the aspiration catheter and the clot

Bernava

Rosi

Boto

et al. 2019

J NeuroIntervent Surg

Self Cite

View full text Add to dashboard Cite

show abstract

“…Experimental models have endorsed this hypothesis and established NeVa™ to be more efficient than other retrievers. 13,24 Furthermore, both pre-clinical and recent clinical evaluations reported no significant adverse effects caused by the device. Pre-clinical animal studies reported artery wall abrasion due to NeVa™ use to be comparable to other stent retrievers.…”

Section: Discussionmentioning

confidence: 86%

“…Pre-clinical animal studies reported artery wall abrasion due to NeVa™ use to be comparable to other stent retrievers. 12,13,25…”

Section: Discussionmentioning

confidence: 99%

“…10,11 The NeVa™ thrombectomy device, designed with Drop Zone technology, a closed distal tip, and strong radial force, has been shown to succeed in these resistant cases in animal and in-vitro models. 12,13 Our goal in this study is to share the clinical success and safety features of the NeVa™ device observed during our initial experience.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Favorable first-pass recanalization rates with NeVa™ thrombectomy device in acute stroke patients: Initial clinical experience

et al. 2020

View full text Add to dashboard Cite

Background The NeVa™ thrombectomy device (Vesalio LLC, Nashville, USA) has been reported to succeed in large vessel occlusion thrombectomy in animal, in-vitro, and clinical studies. Designed with Drop Zone technology, a closed distal tip, and strong expansive radial force, the device demonstrated particular efficiency in resistant “white” thrombi in preclinical research. Our goal is to determine the safety and performance of this novel stent retriever on first-pass rates and overall recanalization. Methods The Interventional Neurology Database is a prospectively maintained database of anterior and posterior circulation stroke thrombectomy cases. We retrospectively analyzed cases where the NeVa™ thrombectomy device was used as the first-line treatment strategy. Data collection occurred between January 2019 and January 2020. First-pass recanalization, final recanalization, 90-day functional outcome, complication, and bleeding rates are reported. Results One hundred eighteen patients were treated with the NeVa™ thrombectomy device. The mean patient age was 69 ± 14 years, the median baseline National Institutes of Health Stroke Scale was 14, and the median initial Alberta Stroke Program Early Computed Tomography score was 8. The median time from groin puncture to successful recanalization was 29 min (interquartile range (IQR): 20–40). First-pass recanalization rates were 56.8% (modified treatment in cerebral infarction (mTICI) 2b/3) and 44.9% (mTICI 2c/3). Final successful recanalization rate was 95.8% (thrombolysis in cerebral infarction 2b/3). Favorable functional outcome (modified Rankin Scale 0–2) was 53% in the “first-pass” subgroup and 42.4% in the total patient population. The median number of passes to achieve the final recanalization score was 1 (IQR 1–2). The rate of embolization into new territory was 1.7%. Four patients (3.3%) had symptomatic hemorrhage. Conclusions In our experience, the NeVa™ device demonstrated high first-pass and overall recanalization rates along with a good safety profile.

show abstract

“…Recent developments in thrombectomy devices aimed to improve the FPR rate and minimize the incidence of distal and new territory embolization. Device features such as flow control,4 the catheter to the vessel ratio,5 6 the diameter and length of the SR,7 the radial force, and the open architectures of the SRs8 9 have been shown to contribute to the degree of achievement of these procedural endpoints.…”

Section: Introductionmentioning

confidence: 99%

Impact of stent-retriever tip design on distal embolization during mechanical thrombectomy: a randomized in vitro evaluation

Tiberi

Bhogal

et al. 2023

J NeuroIntervent Surg

View full text Add to dashboard Cite

BackgroundRepeated number of passes, clot fragmentation, and distal embolization during mechanical thrombectomy (MT) lead to worse clinical outcomes in acute ischemic stroke. This study aimed to assess the recanalization and embolic outcomes of different stent-retrievers (SRs): open-tip SR (Solitaire X 6×40 mm), closed-tip SR (EmboTrap II 5×33 mm), and filter-tip SR (NeVa NET 5.5×37 mm).MethodsStiff-friable clot analogs were used to create middle cerebral artery (M1-MCA) occlusions in a benchtop model. After occlusion, experiments were randomized into one of the three treatment arms. The thrombectomy technique consisted of retrieving the SR into a balloon guide catheter under proximal flow arrest and continuous aspiration. A total of 150 single-attempt cases were performed (50 cases/treatment arm). Distal emboli (>100 µm) were collected and analyzed after each experiment.ResultsFilter-tip SR achieved a non-significantly higher first-pass recanalization rate than open-tip SR and closed-tip SR (66% vs 48% vs 44%; P=0.064). Filter-tip SR prevented clot fragments>1 mm from embolizing distal territories in 44% of cases, compared with 16% in open-tip SR and 20% in closed-tip (P=0.003). There were no significant differences between treatment arms in terms of total emboli count (open-tip=19.2±13.1, closed-tip=19.1±10.7, filter-tip=17.2±13.0; P=0.660). Nonetheless, the number of large emboli (>1 mm) and total area of emboli were significantly lower in the filter-tip arm (n=0.88±1.2, A=2.06±1.85 mm2) than in the closed-tip arm (n=2.34±3.38, A=4.06±4.80 mm2; P<0.05).ConclusionsWhen facing fragment-prone clots, the filter-tip SR significantly reduces the number of large clots (>1 mm) that embolize distally during an MT procedure, which in turn may increase the chances of first-pass complete recanalization.

show abstract

Experimental evaluation of the NeVa™ thrombectomy device a novel stent retriever conceived to improve efficacy of organized clot removal

Abstract: The Neva™ device has demonstrated safety and efficacy in a pre-clinical study. Such encouraging, preliminary results have to be compared with those of clinical trials.

Cited by 11 publications

References 18 publications

Direct thromboaspiration efficacy for mechanical thrombectomy is related to the angle of interaction between the aspiration catheter and the clot

Direct thromboaspiration efficacy for mechanical thrombectomy is related to the angle of interaction between the aspiration catheter and the clot

Favorable first-pass recanalization rates with NeVa™ thrombectomy device in acute stroke patients: Initial clinical experience

Impact of stent-retriever tip design on distal embolization during mechanical thrombectomy: a randomized in vitro evaluation

Contact Info

Product

Resources

About