Paper:
Preclinical safety and efficacy of the NeVa NET™: A novel thrombectomy device with integrated embolic distal protection
Authors:
Vania Anagnostakou MD PhD, Raul G. Nogueira MD, Mark Epshtein, PhD, Matthew J Gounis PhD, Daniel Behme MD, Arthur Ulm MD, Rishi Gupta MDJournal:
Journal of Vascular and Interventional Neurology – FEBRUARY 2023
Background and Purpose:
High quality reperfusion is linked to better clinical outcomes during thrombectomy for large vessel occlusion in acute ischemic stroke. A novel stent-retriever device with an integrated microfilter for embolic distal protection has been developed to improve first pass full reperfusion.Objective:
Compare the safety and effectiveness of the NeVa NET versus the standard stent retriever thrombectomy devices.
Materials and Methods:
- Radial force measurements were performed on 10 NeVa NET and 4 Solitaire™ 6×30 mm.
- Animal studies involving three Yorkshire pigs were performed comparing NeVa NET to Solitaire 6×40 mm and 4×40 mm to assess for acute vascular injury, vasospasm and thrombogenicity during thrombectomy.
- A randomized comparison in a closed loop vascular model was performed to quantify first pass effect and distal emboli generated during twenty MCA thrombectomies.
Results:
- Radial force curves were similar between the NeVa NET and Solitaire 6×30 mm.
- Below 2.5 mm the Solitaire demonstrated higher radial force compared to NeVa NET.
- Vasospasm scores were nearly identical after four thrombectomies in multiple similar-sized swine arteries.
- The addition of the internal filter did not result in increased thrombogenicity in the non-heparinized swine model. In the randomized flow model study.
- The vasospasm study demonstrated findings comparable with predicate devices.
Conclusion:
Our pre-clinical results support the use of the NeVa NET device in a clinical trial to determine if this novel design improves first pass full reperfusion.