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 MD
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.
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.
- 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.
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.