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LAVA®

 

LAVA study

Patients

Safety

 

Patients

1
4
Mean [SD] age, years
Enrolled population [n=113];
57.4[18]
Current anticoagulant
Enrolled population (N=90):
8 (8.9)
3
4
>
Male gender, n (%)
Enrolled population (N=113):
63.7 (72)
Current antiplatelet
use, n (%)
Enrolled population (N=96):
9 (9.4)
3
4
Comorbidities, n (%)
Enrolled population (N=113):
Hypertension - 66 (58.4)
Hyperlipidemia - 36 (31.9)
Renal insufficiency - 32 (28.3)
Diabetes - 28 (24.9)
Coronary artery disease - 21 (18.6)
Smoking - 22 (19.5)
Embolotherapy, n (%)
Targeted lesion population (N=141 lesions):
LAVA alone 105(74.5)
LAVA + Coil - 25(17.7)
LAVA + Plug - 3(2.1)
LAVA + Gelfoam - 6(4.3)
LAVA + Coils + Gelfoam - 2(1.4)
3
>
Mean (range) time
for administration, min
Enrolled population (N=113):
5.9 (1-70)
Reference:
1. https://www.fda.gov/medical-devices/recently-approved-devices/lava-liquid-embolic-system-p220020