Acoustic Pulse Thrombolysis Treatment

Transcription

1 Acoustic Pulse Thrombolysis Treatment BTGVascular.com SETTING THE STANDARD FOR VASCULAR THERAPIES

2 Quickly & safely dissolve thrombus with the EKOS System. The Acoustic Pulse Difference Acoustic Pulse Thrombolysis treatment is a minimally invasive system for dissolving thrombus. The ultrasonic core generates an acoustic field which greatly accelerates lytic dispersion by driving the drug deeper into the clot and unwinding the fibrin to expose plasminogen receptor sites. Acoustic Pulse Thrombolysis Treatment: Speeds time-to-dissolution 15 Increases thrombus removal and clinical improvement compared to either standard Catheter Directed Therapy (CDT) or thrombectomy 1 Lowers the risk of bleeding and other complications 1,4 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 Reduces RV/LV ratio with as little as 8mg total tpa used in combination with EKOS therapy 16 Superior Thrombus Clearance 2,4 : 48% greater drug absorption within 1 hour 8 84% greater drug absorption within 2 hours 8 The Thrombosis Barrier With Acoustic Pulse Tightly wound fibrin prevents lytic from reaching receptor sites. With Acoustic Pulse + Lytic Ultrasonic energy thins fibrin and exposes receptor sites. More drug reaches entire thrombus, accelerating absorption. The EKOS System s targeted ultrasound waves accelerate thrombus dissolution by unwinding the fibrin matrix.

3 Lower patient risk. Higher procedure predictability. Targeting the Thrombus, Safely Reduced Procedure Time 2,4 The EkoSonic Endovascular System includes an ultrasonic core within an infusion catheter, and control unit. 5.4 F Infusion Catheter With EKOS Acoustic Pulse Thrombolysis treatment 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 embolization. 13 The EKOS System s safety and efficacy is supported by Level 1 and Level 2 6, 7, 14, 15, 16 data. 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: 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. Ultrasonic Core Transducer Marker Band Treatment zones range from 6cm to 50cm with radiopaque marker bands at each end of the treatment zone to enhance visualization. At-a-glance operating status, alarms and treatment times are easy to read from a distance. Coolant Therapy Optimization Sensor Drug Delivery Lumen Treatment Zone Ultrasonic Core in Central Lumen Central Coolant Lumen Therapy Optimization Sensor Cross Section

4 Treatment for PE, DVT & PAO Pulmonary Embolism The EkoSonic Endovascular System is the first endovascular device cleared by the FDA for the treatment of pulmonary embolism. The current standard of care, anticoagulation, does not resolve existing thrombus. EKOS has been shown to yield safe and effective results for acute, massive (high risk) and submassive (intermediate risk) PE. It improves right ventricular function and pulmonary artery pressure while minimizing the risk of bleeding. 1 In the Seattle II study of 150 patients with massive or acute intermediate-risk PE using an EKOS and lytic combination, the mean RV/LV ratio decreased from 1.55 pre-procedure to 1.13 at 48 hours post-procedure (P<0.0001) while PA systolic pressure decreased from 51.4 mm Hg to 36.9 mm Hg (P<0.0001). In contrast to the 2.5 3% rate of intracranial hemorrhaging associated with historical systemic fibrinolysis and full-dose tpa, no patients in this study experienced intracranial bleeding or fatal bleeding events. 7 Deep Vein Thrombosis The EkoSonic Endovascular System dissolves thrombus more completely even behind valves and IVC filters. 5 It quickly restores blood flow, potentially reducing the risk of pulmonary embolism and postthrombotic syndrome (PTS). Approximately 50% of patients with acute ilio-femoral DVT develop PTS. 9 A low-dose lytic and EKOS regimen has been associated with a low-bleeding rate and high venous patency with 90% of patients experiencing no DVT complications. 11 In the ACCESS PTS study, 73 patients with chronic DVT treated with a regimen of both balloon dilatation and EKOS therapy saw a significant reduction in Villalta Score of 49% and a 36% improvement in VEINES-QOL at one year. 18 Peripheral Arterial Occlusion The EkoSonic Endovascular System improves on standard CDT by safely accelerating drug penetration, even in difficult-to-reach areas. Compared to traditional CDT the EkoSonic Endovascular System offers: Shorter treatment times 2 Higher dissolution rate of entire thrombus (95.3% vs. 66.7%, p=0.002) 2 Lower bleeding rates (4.7% vs. 23.8%, p=0.026) 2 Lower 30-day amputation rate (19.5% vs. 42.9%, p=0.04) 2 Shorter hospital stays (5.7 vs. 8.3 days, p=0.027) 2 In the OPTALYSE PE study of 101 patients with submassive PE utilizing EKOS therapy, each of the OPTALYSE 2, 4 & 6 hr cohorts reduced RV/LV ratio by 23-26%. Total tpa doses in the study ranged from 8-24mgs bilaterally and the bleeding rate was a very low 3%. The one-year data demonstrated a 2% mortality rate - significantly below both anticoagulation and systemic therapy. 16,17 Pre PE: RV/LV Ratio: 1.73, 2h infusion; 8mg total r-tpa Pre DVT: Left SFV with thrombus Pre SFA Occlusion: Pre-procedural angiography Post PE: RV/LV Ratio: 0.98 Post DVT: Thrombus completely resolved Post SFA Occlusion: Completion angiography

5 The fast, safe solution for vascular thrombosis. The EkoSonic Endovascular System: Pulmonary Embolism Reduces RV/LV ratio by more than 23% on average in as little as 2 hours 16 Reduces PA pressures by 28% (at 48 hours) 7 76% less thrombolytic drug dosage than standard treatment 7 Minimized risk of bleeding 1 Quality clinical outcomes Predictable results Minimized bleeding risk Efficient procedures The EKOS effect 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. Deep Vein Thrombosis Up to 50% of DVT patients have PE 9 Removes thrombus more completely compared to CDT 4 Reduces post-thrombotic syndrome 11 Arterial Occlusion Lower 30-day amputation rate 2 Lower bleeding rates when compared to CDT 2 Higher complete dissolution rate of thrombus 2 The EkoSonic Endovascular System 106cm Working Length: Includes one 5.4 F infusion catheter (106cm long, inch guidewire compatible) and one ultrasonic core matched to infusion length cm Treatment Zone cm Treatment Zone cm Treatment Zone cm Treatment Zone cm Treatment Zone cm Treatment Zone cm Treatment Zone 135cm Working Length: Includes one 5.4 F infusion catheter (135cm long, inch guidewire compatible) and one ultrasonic core matched to infusion length cm Treatment Zone cm Treatment Zone cm Treatment Zone cm Treatment Zone

6 References 1. 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 S Litzendorf, M., et al., Ultrasound-Accelerated Thrombolysis Is Superior to Catheter-Directed Thrombolysis for the Treatment of Acute Limb Ischemia. Journal of Vascular Surgery, Jun 2011; 53(Suppl S), p106s-107s. 3. 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 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, 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): 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, 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, Francis, C.W., et al., Ultrasound Accelerates Transport of Recombinant Tissue Plasminogen Activator into Clots. Ultrasound in Medicine and Biology, 21.3, 1995, 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, Mewissen, et al., Catheter-directed Thrombolysis for Lower Extremity Deep Venous Thrombosis: Report of a National Multicenter Registry. Radiology, 1999 Apr; 211(1): 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, Soltani, A., et al., Absence of Biological Damage from Prolonged Exposure to Intravascular Ultrasound: A Swine Model. Ultrasonics, 46, 2007, Braaten, J.V., et al., Ultrasound Reversibly Disaggregates Fibrin Fibers. Journal of Thrombosis and Haemostasis, 78, 1997, Wissgott C., et al., Treatment of Critical Limb Ischemia Using Ultrasound-Enhanced Thrombolysis (PARES TRIAL): Final Results. Journal of Endovascular Therapy, 14(4), 2007, Schrijver, A.M., et al., Dutch Randomized Trial Comparing Standard Catheter-Directed Thrombolysis Versus Ultrasound-Accelerated Thrombolysis for Arterial Thromboembolic Infrainguinal Disease (DUET) Journal of Endovascular Therapy 2015; 22(1): Tapson, Victor, et al., A Randomized Trial of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Intermediate-Risk Pulmonary Embolism: The OPTALYSE PE Trial. JACC: Cardiovascular Interventions Jul 2018, 11 (14) Konstantinides, MD, et al, Impact of Thrombolytic Therapy on the Long-Term Outcome of Intermediate-Risk Pulmonary Embolism Journal of the American College of Cardiology; vol 69, pp , Garcia, M. et al. ACCElerated thrombolysis for Post-Thrombotic Syndrome using the Acoustic Pulse Thrombolysis EkoSonic Endovascular System: One Year Results. As presented at the Society for Interventional Radiology Meeting, Los Angeles, CA, March Product availability varies by country. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Prior to use, please refer to the applicable Instructions for Use (IFU) for complete product indications, contraindications, warnings, and precautions. EKOS, the EKOS logo, Acoustic Pulse Thrombolysis, and EkoSonic are trademarks of Ekos Corporation, a BTG International group company. BTG and the BTG roundel logo are trademarks of BTG International Ltd. EKOS, the EKOS logo, BTG and the BTG roundel logo are registered trademarks in the US, EU and certain other territories. BTG Vascular United States N. Creek Pkwy S. Bothell, WA Europe, Middle East & Africa Lakeview, Riverside Way, Watchmoor Camberley, Surrey GU15 3YL UK ekoscustomerservice@btgplc.com CE-EKO September 2018 BTGVascular.com SETTING THE STANDARD FOR VASCULAR THERAPIES