Neva
Designed for first-pass success with all types of clots. Uniquely designed with Drop Zone technology to capture clot inside the device.
Greater success on the first pass.
The NeVa mechanical thrombectomy system is temporarily inserted into the cerebral or coronary vascular system under angiographic visualization to restore blood flow and remove thrombus in arteries or vessels blocked by thromboembolic material. The system is available in various sizes and configurations.
STUDY A
STUDY B
Superior first pass success
STUDY A
Successful first pass recanalization: percentage of eTICI 2B-3 in the CLEAR study (mITT, n = 107)
STUDY B
Excellent first pass recanalization: percentage of eTICI 2C-3 in the CLEAR study (mITT, n = 107)
* Core-lab adjudicated results from FDA-regulated IDE study NeVa CLEAR presented by Yoo A, et al. abstract 4311, ISC, Feb. 2023
Highly efficacy design agnostic to clot morphology*
* Results from in-vitro simulated thrombectomy studies: Machi P, et al. Journal of Neuroradiology. April 2018. Results from animal model study: Ulm A.J. et al. Interventional Neurology 2018 ; 7 :205-2017
STUDY A
Successful in removing all clot types.
Neva recanalization rates in different clot morphologies.
Results from animal model study: Ulm A.J. et al. Interventional Neurology 2018 ; 7 :205-2017
STUDY B
Successful where other devices fail.
Success rate of stent retrievers when interaction with large white thrombi (≥6 mm)
Results from in-vitro simulated thrombectomy studies: Machi P, et al. JNIS. 2016; 0:1–7 and Machi P, et al. Journal of Neuroradiology. April 2018
STUDY A
STUDY B
ALL TESTED DEVICES FAILED:
Eric – Separator 3D
0%
NEVA SUCCEEDED:
60%
STUDY A
STUDY B
Proven safety*
* Results from FDA-regulated IDE study NeVa CLEAR presented by Yoo A, et al. abstract 4311, ISC, Feb. 2023.
STUDY A
Composite endpoint of 90-day all-cause mortality and/or 24-hour post-procedure sICH (ITT, n = 139)
STUDY B
Superior clinical outcomes (mRS ≤ 2 at 90 days) in the CLEAR study versus with predicate studies (mITT, n = 107).
Maximized retention, Maximized reperfusion
Significantly better at preventing clot fragments from embolizing distal territories*
Results from randomized, in-vitro simulated thrombectomy studies: Vania et al. JVIN, Feb 2023, Li et al. JNIS, May 2023
Clot fragments generated*
Results from randomized, in-vitro simulated thrombectomy studies: Vania et al. JVIN, Feb 2023
Frequency of large emboli generated.*
Results from randomized, in-vitro simulated thrombectomy studies: Li et al. JNIS, May 2023
28% LESS
FRAGMENTS > 1mm generated versus Solitaire
P=0.003
24% LESS
FRAGMENTS >1mm generated versus Embotrap 2
P=0.003
Total area of emboli generated.*
Results from randomized, in-vitro simulated thrombectomy studies: Li et al. JNIS, May 2023
The structure in detail
Product Number
30020V-MS
VN-4529-03RR
VN-5537-03RR
VN-5537-03NR
Description
NeVa 4.0 x 22 mm
NeVa 4.5 x 29 mm
NeVa 5.5 x 37 mm
NeVa NET 5.5 x 37 mm
Diameter (mm)
4.0
4.5
5.5
5.5
Working Lemgth (mm)
22
29
37
37
39
46
56
56
Push-wire Length (mm)
180
180
180
180
Number of Drop Zones
2
3
3
3
Minimum MC ID (Inches)
.021″
.021″
.027″
.027″
