Download EKOS ® Acoustic Pulse Thrombolysis ™ Treatment

EKOS
Acoustic
Pulse
Thrombolysis
™
™
Quickly
& safely
dissolve
thrombus
with the
EKOS
System.
The Acoustic Pulse Difference
EKOS™ Acoustic Pulse Thrombolysis™ is a minimally
invasive system for dissolving thrombus. The ultrasonic
core generates a localised acoustic field which greatly
accelerates lytic dispersion by driving the drug deeper
into the clot and unwinding the fibrin to expose
plasminogen receptor sites.
Treatment for PE, DVT & PAO
The Thrombosis Barrier
™
Treat
smarter.
Achieve
more.
Acoustic Pulse Thrombolysis™:
•
Speeds time-to-dissolution.
•
Increases thrombus removal and clinical improvement
compared to either standard Catheter Directed
Therapy (CDT) or thrombectomy.1,5
•
Lowers the risk of bleeding and other complications1,4
Tightly wound fibrin prevents lytic
from reaching receptor sites.
With Acoustic Pulse
More Effective Drug Delivery:
•
•
™
Reduces dosage requirements by as much
as 68% compared to standard CDT. 4
Requires up to 4x less drug dosage than
systemic delivery.6,7
Superior Thrombus Clearance2,4:
•
48% greater drug absorption within 1 hour. 8
•
84% greater drug absorption within 2 hours.8
Ultrasonic energy thins fibrin
and exposes receptor sites.
Pulmonary Embolism
Deep Vein Thrombosis
Peripheral Arterial Occlusion
The EkoSonic™ Endovascular System is the only
endovascular device cleared by the FDA for the
treatment of pulmonary embolism. The current standard
of care, anti-coagulation, does not resolve existing
thrombus. EKOS™ has been shown to yield safe and
effective results for acute, massive and submassive
PE. It improves right ventricular function and pulmonary
artery pressure while minimising the risk of bleeding.6
The EkoSonic™ Endovascular System dissolves
thrombus more completely even behind valves and
IVC filters.9 It quickly restores blood flow, potentially
reducing the risk of pulmonary embolism and
post- thrombotic syndrome (PTS), which affects
approximately 50% of patients with acute
ilio-femoral DVT.10
The EkoSonic™ Endovascular System accelerates drug
penetration, even in difficult-to-reach areas.
Studies with EKOS™ demonstrate:
The ULTIMA study was a randomised controlled trial
of 59 patients comparing heparin plus EKOS™ therapy
(n=30) to heparin alone (n=29) for the treatment of
intermediate risk PE.
• EKOS™ reversed RVD at 24 hours, with a reduction
in RV/LV ratio of 23% compared to 3% with heparin
alone, using 20 mg tPA over 15hrs, with a safety
profile equivalent to heparin.6
•
•
Higher rates of complete lysis and shorter infusion
time compared to traditional CDT4,16
Between 35% - 68%* reduction in thrombolytic dose
compared to traditional CDT4
*depending on thrombolytic drug used.
Compared to traditional CDT EKOS™ offers:
•
Shorter treatment times
•
Higher dissolution rate of entire thrombus
(95.3% vs. 66.7%, p=0.002)
•
Lower bleeding rates
(4.7% vs. 23.8%, p=0.026)
•
Lower 30-day amputation rate
(19.5% vs. 42.9%, p=0.04)
•
Shorter hospital stays
(5.7 vs. 8.3 days, p=0.027)2
•
Evidence of clearance behind valves and in IVC
filters4,9
The SEATTLE II study (n=150), using an EKOS™ and lytic
combination to evaluate safety and efficacy for massive
and sub-massive PE patients, demonstrated:
• RV/LV ratio decreased from 1.55 pre-procedure to
1.13 at 48 hours post-procedure (p<0.0001)
• PA systolic pressure decreased from 51.4 mm Hg to
36.9 mm Hg (p<0.0001)
• No intracranial haemorrhage, in contrast to the 2.53% in historical full-dose, systemic fibrinolysis studies7
•
90% of patients experiencing no DVT complications11
•
90% vessel patency at long term follow up11
Pre-Treatment PE:
Pre-Treatment DVT:
Pre-Treatment SFA Occlusion:
RV/LV Ratio: 1.73, RV Diameter: 65.5mm, LV Diameter: 37.9mm
Left SFV with thrombus
Pre-procedural angiography
Post-Treatment PE:
Post-Treatment DVT:
Post-Treatment SFA Occlusion:
RV/LV Ratio: 0.98, RV Diameter: 60.4mm, LV Diameter: 61.5mm
Thrombus completely resolved
Completion angiography
With Acoustic Pulse + Lytic
More drug reaches entire thrombus,
accelerating absorption.
Since its beginning, EKOS™ has had
one goal: develop life-enhancing
and lifesaving endovascular
treatments for vascular thrombosis.
EKOS™ is committed to developing
device-based therapies that improve
patient outcomes, lower risks and
improve treatment predictability.
The EKOS™ System’s
targeted ultrasound waves
accelerate thrombus dissolution
by unwinding the fibrin matrix.
“Patients
stricken with a
life-threatening
pulmonary embolism
can be successfully
and safely treated
™
with EKOS. ”
Lower
patient risk.
Higher
procedure
predictability.
The EkoSonic™ Endovascular System includes an
ultrasonic core within an infusion catheter, and
control unit.
Targeting the Thrombus, Safely
Reduced Procedure Time2,4
With EKOS™ Acoustic Pulse Thrombolysis,™ most of the
drug remains in the thrombus and you can typically use
less lytic. It dissolves the thrombus without damaging
vessels, valves or walls.4, 12 There is no mechanical
disruption resulting in distal embolisation.13
EKOS™ requires significantly shorter treatment times,
typically only 33–50% of standard CDT. Unlike more
complex surgical solutions,1, 5 EKOS™ is an efficient,
three-step process:
The EKOS System’s safety and efficacy is supported by
Level 1 and Level 2 data.6, 7, 14, 15
™
5.4 F Infusion Catheter
1) Insert the EKOS™ 5.4 F infusion catheter through
the thrombus.
2) Insert the ultrasonic core until it locks in place.
3) Activate the lytic infusion and acoustic pulse.
Treatment zones range from 6cm to 50cm with
radiopaque marker bands at each end of the treatment
zone to enhance visualisation. At-a-glance operating
status, alarms and treatment times are
easy to read from a distance.
Ultrasonic Core
Transducer
Marker Band
Coolant
At-a-glance user interface
makes it easy to optimise
settings during lysis.
Therapy Optimisation Sensor
Treatment Zone
Drug Delivery Lumen
Central Coolant Lumen
Ultrasonic Core in Central Lumen
Therapy Optimisation Sensor
Samuel Z. Goldhaber, MD.
Professor of Medicine, Harvard Medical School
Director, Thrombosis Research Group, Brigham and Women's Hospital
Cross Section
The fast,
safe solution
for vascular
thrombosis.
1
2
3
4
5
6
7
8
Lin, P., et al., “Comparison of Percutaneous Ultrasound-Accelerated Thrombolysis versus Catheter-Directed Thrombolysis in Patients with Acute Massive Pulmonary Embolism.” Vascular, Vol. 17, Suppl. 3, 2009, S137–S147.
Litzendorf, M., et al., “Ultrasound-Accelerated Thrombolysis Is Superior to Catheter-Directed Thrombolysis for the Treatment of Acute Limb Ischemia.” SVS 2011 Abstract RR20.
De Vries, J., et al., “RCT Comparing Standard Thrombolysis with US Accelerated Thrombolysis: The DUET Study and Beyond.” Charing Cross International Symposium, London, UK, April 2014.
Parikh, S., et al., “Ultrasound-Accelerated Thrombolysis for the Treatment of Deep Vein Thrombosis: Initial Clinical Experience.” Journal of Vascular and Interventional Radiology, Vol. 19, Issue 4, April 2008, 521–528.
Lin, P., et al., “Catheter-Directed Thrombectomy and Thrombolysis for Symptomatic Lower-Extremity Deep Vein Thrombosis: Review of Current Interventional Treatment Strategies.” Perspectives in Vascular Surgery and
Endovascular Therapy, 2010, 22(3): 152–163.
Kucher, N., et al., “Randomized, Controlled Trial of Ultrasound-Assisted Catheter-Directed Thrombolysis for Acute Intermediate-Risk Pulmonary Embolism.” Circulation, Vol. 129, No. 4, 2014, 479–486.
Piazza, G., et al., “A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism (Seattle II).” American College of Cardiology 63rd Annual Scientific
Session, Washington, D.C., March 30, 2014.
Francis, C.W., et al., “Ultrasound Accelerates Transport of Recombinant Tissue Plasminogen Activator into Clots.” Ultrasound in Medicine and Biology, 21.3, 1995, 419–424.
9
The EkoSonic Endovascular System:
™
•
Quality clinical outcomes
•
Predictable results
•
Minimised bleeding risk
•
Efficient procedures
•
•
•
Reduces RV/LV ratio by more than 25%
on average7
Reduces PA pressures by 28% (at 48 hours)7
76% less thrombolytic drug dosage than
standard treatment7
•
Minimised risk of bleeding6
•
50% of DVT patients have PE10
•
•
Removes thrombus more completely
compared to CDT16
Reduce post-thrombotic syndrome11
Patel, M.S., et al., “Pharmacomechanical Catheter Directed Thrombolysis to Treat Inferior Vena Cava Filter Thrombosis.” Journal of Vascular and Interventional Radiology, 23 (3), 2012, S119.
10
Kahn, Sr. Shrier I. Julien, J.A., et al., “Determinants and Time Course of the Post-thrombotic Syndrome After Acute Deep Venous Thrombosis.” Annals of Internal Medicine, 149, 2008, 698–707.
11
Engelberger, R., et al., “Fixed, Low-Dose Ultrasound-Assisted Catheter-Directed Thrombolysis Followed by Routine Stenting of Risidual Stenosis for Acute Ilio-Femoral Deep-Vein Thrombosis.” Journal of Thrombosis and
Haemostasis, 2014, 111.6.
12
Soltani, A., et al., “Absence of Biological Damage from Prolonged Exposure to Intravascular Ultrasound: A Swine Model.” Ultrasonics, 46, 2007, 60–67.
13
Braaten, J.V., et al., “Ultrasound Reversibly Disaggregates Fibrin Fibers.” Journal of Thrombosis and Haemostasis, 78, 1997, 1063­–8.
14
Wissgott C., et al., “Treatment of Critical Limb Ischemia Using Ultrasound-Enhanced Thrombolysis (PARES TRIAL): Final Results.” Journal of Endovascular Therapy, 14(4), 2007, 438–443.
15
Schrijver, A.M., et al., “Dutch Randomized Trial Comparing Standard Catheter-Directed Thrombolysis Versus Ultrasound-Accelerated Thrombolysis for Thromboembolic Infrainguinal Disease (DUET): Design and Rationale.”
Trials, 2011, 12:20.
16
Mewissen, et al., “Catheter-directed Thrombolysis for Lower Extremity Deep Venous Thrombosis: Report of a National Multicenter Registry.” Radiology, 1999 Apr; 211(1): 39-49.
The EkoSonic™ Endovascular System
106cm Working Length: Includes one 5.4 F infusion catheter
(106cm long, 0.035 inch guidewire compatible) and one ultrasonic core
matched to infusion length.
The EKOS™ effect (in green) changes the standard of care
for pulmonary embolism and dissolves the thrombus more
completely, even in difficult-to-reach areas for deep vein
thrombosis and peripheral arterial occlusion.
•
Lower 30-day amputation rate2
•
Lower bleeding rates when compared to CDT2
•
Higher complete dissolution rate of thrombus2
500-55106
6cm Treatment Zone
500-55112
12cm Treatment Zone
500-55118
18cm Treatment Zone
500-55124
24cm Treatment Zone
500-55130
30cm Treatment Zone
500-55140
40cm Treatment Zone
500-55150
50cm Treatment Zone
135cm Working Length: Includes one 5.4 F infusion catheter
(135cm long, 0.035 inch guidewire compatible) and one ultrasonic core
matched to infusion length.
500-56112
12cm Treatment Zone
500-56130
30cm Treatment Zone
500-56140
40cm Treatment Zone
500-56150
50cm Treatment Zone
All EKOS™ products are latex free.
600-20000
EkoSonic™ Control Unit with CIC and CIC Clip.
EKOS™ Acoustic Pulse Thrombolysis™
accelerates thrombus dissolution.
Contact us:
Address: Lakeview, Riverside Way, Watchmoor Park,
Camberley, Surrey GU15 3YL UK
Email: [email protected]
Website:www.ekoscorp.com
Online Learning Center: www.ekoscorp.com/learningcenter.htm
About EKOS™
About BTG
EKOS Corporation, a BTG International group company, pioneered the
development and clinical application of ultrasound infusion technologies
in medicine, introducing its first system for the treatment of vascular
thrombosis in 2005. Today, interventional radiologists, cardiologists, and
cardiothoracic and vascular surgeons at leading institutions around the
world use the EKOS™ EkoSonic™ Endovascular System to provide faster,
safer and more complete dissolution of thrombus. To find out more
about the EKOS™ EkoSonic™ Endovascular System, visit www.ekoscorp.
com.
BTG is a growing international specialist healthcare company that is
developing and commercialising products targeting acute care, cancer
and vascular diseases.
EKOS, the EKOS logo, EkoSonic, ‘Treat Smarter, Achieve More’ and
‘Acoustic Pulse Thrombolysis’ are trademarks of EKOS Corporation, a
BTG International group company. EKOS is a registered trademark in the
US, EU and certain other territories. ’Imagine where we can go’, BTG and
the BTG roundel logo are trademarks of BTG International Ltd. BTG and
the BTG roundel logo are registered trademarks in the US, EU and certain
other territories.
All rights reserved. © 2014 EKOS Corporation. GxUS-EKO-2014-0100
The company has diversified revenues from sales of its own marketed
products and from royalties on partnered products, and is seeking to
acquire new programs and products to develop and market to specialist
physicians.
To find out more about the BTG International group companies and our
products, visit www.btgplc.com.
INDICATIONS FOR USE: The EkoSonic™ Endovascular System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral
vasculature. The EkoSonic™ Endovascular System is CE Marked for the treatment of pulmonary embolism with a ≥50% clot burden in one or both main pulmonary arteries or lobar pulmonary
arteries, and evidence of right heart dysfunction based on right heart pressures (mean pulmonary artery pressure ≥25 mmHg) or echocardiographic evaluation. Contraindications: Not designed
for peripheral vasculature dilation purposes. This system is contraindicated when, in the medical judgment of the physician, such a procedure may compromise that patient’s condition. Such
conditions include but are not limited to: • Tortuous vascular anatomy compromising safe introduction of endovascular equipment • Conditions associated with increased risk of bleeding. See
device instructions for use for complete prescribing information
http://ekoscorp.com/international_enter.htm#Resources