The company said in the HI-PEITHO trial that the EKOS system plus anticoagulation was superior to anticoagulation alone, and that the combined 1 primary endpoint rate fell 61% to 4.0% from 10.3% (P=0.005).

1. 01

   The company said in the HI-PEITHO trial that the EKOS system plus anticoagulation was superior to anticoagulation alone, and that the combined 1 primary endpoint rate fell 61% to 4.0% from 10.3% (P=0.005).

2. 02

   The company said the combined 1 primary endpoint consisted of PE-related death, non-fatal hemodynamic cardiorespiratory decompensation or collapse, and non-fatal symptomatic PE recurrence within 7 days.

3. 03

   The company said the rate of cardiorespiratory decompensation or collapse in patients treated with the EKOS system was 3.7% versus 10.3%, and that there were no episodes of bleeding within the brain through 30 days.

4. 04

   The company said the HI-PEITHO trial is a randomized controlled study that enrolled 544 patients with intermediate-risk PE across 59 sites in the United States and Europe, and that results were presented at ACC.26 and simultaneously published in The New England Journal of Medicine.

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AI summarized the filing and translated the summary into English; it may differ from the original. For reference only, not investment advice. AI translated the published Korean report into English. Figures are copied as filed, not recalculated.

Original filing

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