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EkoSonic®
SV (Small Vessel) Endovascular System
 The
EkoSonic SV Endovascular System incorporates the
same fundamental innovative ultrasonic accelerated thrombolysis
technology used in all EKOS products.
This technology’s acoustical properties enhance the
clots’ capacity to absorb the lytic, resulting in
the acceleration of lysis.
MicroSonic SV Endovascular Device:
- 3F
microcatheter
-
150cm working
length
- Central lumen,
end hole infusion
- Ultrasound
element at tip
The device design
provides flexibility comparable to a leading
neurocatheter. With this level of flexibility it can
easily navigate small vessels within the body. |
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EKOS Recommends
- 6FR (0.068”
min. ID) guide catheter
- 0.014” medium
or stiff polymer tip guidewire
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Indications
Neuro
Vasculature: The EkoSonic SV Endovascular
System is intended for regional infusion of
contrast materials into selected vessels in the neurovasculature. The EkoSonic SV Endovascular
System may be used for controlled, regional
infusion into selected vessels.
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The safety
and effectiveness of the EkoSonic SV
Endovascular System for thrombolytic therapy
in the neurovasculature have not been
established. Further clinical studies are
necessary to ensure that use of devices to
deliver thrombolytic therapy into the
neurovasculature does not result in an
increased incidence of adverse events (e.g.,
intracranial hemorrhage). |
Coronary
Vasculature: The EkoSonic SV Endovascular
System is intended to deliver physician
specified fluids to the coronary vasculature.
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The safety
and effectiveness of the EkoSonic SV
Endovascular System used for intracoronary
thrombolytic therapy administration have not
been established. In particular, the
ultrasound energy delivered by the EkoSonic
SV Endovascular System is not intended to
be therapeutic, and the safety and
effectiveness of the EKOS system for
coronary thrombolysis or thrombectomy (i.e.
clot disruption) have not been established. |
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