OPTALYSE PE Study
EKOS Endovascular System PE Clinical Studies

Optimum Duration and Dose of tPA with the Acoustic Pulse Thrombolysis Procedure for Submassive Pulmonary Embolism: OPTALYSE PE
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) 1401-10

Key Results

RV/LV ratio continued to reduce after 48 hours.
P value <0.0001 @ 365 days.
Long-term OPTALYSE safety & efficacy at 365 days.
PEmb-QoL score decreased for all cohorts.
PROMIS-PF score increased for all cohorts.

Conclusions

The EKOS System’s very low dose and short duration regimens, in the OPTALYSE PE Trial, resulted in rapidly improved measures of right-heart function that were maintained for one year. Additionally, the favourable mortality rates, recurrent PE rates, and quality-of-life results demonstrate long-term benefits of EKOS therapy. This data further proves the PE clinical efficacy and safety of the OPTALYSE PE treatment protocols.