The most studied device in the space.
EKOS therapy changes the standard of care for pulmonary embolism and dissolves the thrombus more completely, even in difficult-to-reach areas.
EKOS has been shown to yield safe and effective results for acute, massive and submassive PE. It quickly improves right ventricular function and pulmonary artery pressure while minimizing the risk of bleeding.1
- Reduces RV/LV ratio by more than 23% on average in as little as 2 hours8
- Reduces PA pressures by 28% (at 48 hours)5
- 76% less thrombolytic drug dosage than standard treatment5
- Minimized risk of bleeding1
In the Seattle II study of 150 patients with massive or submassive intermediate-risk PE using the combination of ultrasound and lytic, the mean RV/LV ratio decreased from 1.55 pre-procedure to 1.13 at 48 hours post-procedure (-<0.0001) while PA systolic pressure decreased from 51.4mmHg to 36.9mmHg (P<0.0001). In contrast to the 2.5-3% rate of intracranial hemormaging associated with historical systemic fibrinolysis and full-dose tPA, no patients in this study experienced intracranial bleeding or fatal bleeding events.7
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 8-24 mgs 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
- 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.” Journal of Vascular Surgery, Jun 2011; 53(Suppl S), p106S-107S.
- 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.
- 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.
- 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.
- 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.
- 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) 1401-1410.