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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