Positive late-breaking clinical trial data for the EkoSonic Endovascular System presented at VIVA21 meeting.
Data from the KNOCOUT PE registry – established to measure institutional adoption of a lower dose and lower-duration thrombolysis protocol for the EKOS system – confirmed the safety and efficacy of the EKOS system for the treatment of patients with intermediate-high and high-risk pulmonary embolism (PE).
The international registry of 489 patients across 83 centers included data from patients treated with the EKOS system who were provided a lower drug dose and shorter infusion duration of a thrombolytic agent than administered in previous studies, reflecting contemporary clinical practice .In the data, there were no intracerebral hemorrhagic (ICH) events, or brain bleeding events, with a low major bleeding rate of 2.5%, compared to the rate previously observed with systemic thrombolysis treatment. Results also demonstrated a 23% post-procedure reduction in the main indicator of heart strain from PE, measured as right ventricular to left ventricular diameter ratio (RV/LV).
The ultrasound technology used by the EKOS system accelerates thrombolysis – the breakdown of the clot – minimizing the time it takes to treat a patient and lowering the necessary thrombolytic dose, which can result in optimized outcomes and a lower risk of bleeding.