
The
EkoSonic®
Endovascular System
now with MACH4e
EKOS set
the standard for safety and completeness in
dissolving clots with its first generation of
MicroSonic™ technology.
It raised the bar with MACH4. And now, EKOS
scientists have refined the performance yet again
with MACH4e; up to 40% faster1 than MACH4.
With no evidence of thrombus breakage2. And no
hemolysis3. Less time to complete dissolution means
a lower lytic drug dosage.
And that means an even
lower risk of complications.
A preferred alternative to current therapies
-
Penetrates thrombus, in difficult–to-reach
places, such as behind valves4
- Uses 50 - 70% less lytic drug4
- No thrombus fracture or breakage2, reducing the
risk of distal embolism
- Exposes thrombus to greater drug uptake5
- Captures drug within thrombus5
- No damage to valves3
or the vascular wall
- No hemolysis3. Does not fracture red blood
cells, so there is no adenosine release and no additional compromise to renal
function
- Higher level of vessel patency, Removes the
thrombus more completely, possibly reducing the
risk of Post-Thrombotic Syndrome (PTS)
- Shortest physician lab time
Intended Use
The EkoSonic
Endovascular Device
is intended for controlled and selective
infusion of physician-specified fluids,
including thrombolytics, into the peripheral vasculature.
Contraindications* Not designed for peripheral
vasculature dilation purposes.* This system is
contraindicated when, in the medical judgment of the physician, such
procedure may compromise the patient’s
condition.
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Indications
Peripheral
Vasculature: Both the EkoSonic Endovascular System
and the EkoSonic
SV Endovascular Systems are
intended for controlled and selective infusion
of physician-specified fluids, including thrombolytics, in the peripheral vasculature.
Pulmonary
Artery: The EkoSonic Endovascular System is
intended for the controlled and selective
infusion of physician – specified fluids
including thrombolytics, into the peripheral
vasculature. The EkoSonic Endovascular System
is also intended for the infusion of solutions
into the Pulmonary Arteries.
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The Safety and effectiveness of the EkoSonic
Endovascular System for thrombolytic therapy
administration in pulmonary embolus have not
been established. In particular, the ultrasound
energy delivered by the EkoSonic System is not
intended to be therapeutic, nor has it been
cleared with an indication for thrombolysis in
pulmonary emboli. |
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Video
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EKOS in
vitro data on file
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Braaten, J., Goss, R., Francis, C. “Ultrasound
Reversibly Disaggregates Fibrin Fibers.” Thromb
Haemost 78 (1997) 1063-8.4.
-
Soltani, A., et al “Absence of biological damage
from prolonged exposure to intravascular
ultrasound.” Ultrasonics 46 (2007) 60-67
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Parikh, S., et al. Ultrasound-Accelerated Thrombolysis for the Treatment of Deep Vein
Thrombosis: Initial Clinical Experience. Journal of
Vascular and
Interventional Radiology, April, 2008, 19:4,
pp521-528.1
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Francis, CW. et al. “Ultrasound Accelerates
Transport of Recombinant Tissue Plasminogen
Activator into Clots.” Ultrasound in Medicine and
Biology, 21.3 (1995): 419-424
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Soltani A, Volz KR, Hansmann DR. “Effect of
modulated ultrasound parameters on
ultrasound-induces thrombolysis”. Phys Med Biol.
2008. Phys Med Biol, 2008
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