Abstract
Introduction
The
ANA™ (Anaconda Biomed) thrombectomy system is a novel stroke
thrombectomy device comprising a self-expanding funnel designed to
reduce clot fragmentation by locally restricting flow while becoming as
wide as the lodging artery. Once deployed, ANA allows distal aspiration
in combination with a stentretriever (SR) to mobilize the clot into the
funnel where it remains copped during extraction. We investigate safety
and efficacy of ANA™ in a first-in-man study.
Methods
Prospective
data was collected on 35 consecutive patients treated as first line
with ANA™ at a single centre. Outcome measures included per-pass
reperfusion scores, symptomatic intracerebral hemorrhage (sICH), NIHSS
at day 5, and mRS at 90 days.
Results
Median
NIHSS was 12(9-18). Sites of primary occlusion were: 5 ICA, 15 M1-MCA,
15 M2-MCA. Primary performance endpoint, mTICI 2b-3 within 3 passes
without rescue therapy was achieved in 91.4% (n = 32) of patients; rate
of complete recanalization (mTICI 2c-3) was 65.7%. First pass complete
recanalization rate was 42.9%, and median number of ANA passes 1(IQR:
1-2). In 17.1% (n = 6) rescue treatment was used; median number of
rescue passes was 2(1-7), leading to a final mTICI2b-3rate of 94.3%
(n = 33). There were no device related serious adverse events, and rate
of sICH was 5.7% (n = 2). At 5 days median NIHSS was 1 (IQR 1-6) and 90
days mRS 0-2 was achieved in 60% of patients.
Conclusions
In
this initial clinical experience, the ANA™ device achieved a high rate
of complete recanalization with a good safety profile and favourable 90
days clinical outcomes.
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