EKOS Therapy
Clinical Overview
Bibliography
Case Library
EKOS Therapy
Clinical Overview
Bibliography
Case Library
Vascular Surgery / Venous Thromboembolism Portal / Learning Center / Clinical Overview


What are the outcomes of clinical trials conducted on EKOS System? This clinical overview presents all the completed and ongoing studies on Acoustic Pulse Thrombolysis.

 

Clinical Overview

 

 

The EkoSonic Endovascular System is the first endovascular device with FDA Clearance and CE Mark 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 minimising the risk of bleeding.1
ULTIMA Study

 

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 haemorrhaging associated with historical systemic fibrinolysis and full-dose tPA, no patients in this study experienced intracranial bleeding or fatal bleeding events.7

SEATTLE II Study

 

 

Nykamp & Laurich Study

 

In the OPTALYSE PE study of 101 patients with submassive PE utilising EKOS therapy, each of the OPTALYSE 2, 4-hour and 6-hour cohorts reduced RV/LV ratio by 23-26%. Total tPA doses in the study ranged from 8mg-24mg 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

OPTALYSE PE Study
optalyse-second-study
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