HI-PEITHO, presented as the first Late-Breaking Clinical Trial (LBCT) session at The American College of Cardiology’s Annual Scientific Session & Expo (ACC.26) with a simultaneous publication in The New England Journal of Medicine, is the first large-scale global randomized controlled trial (N=544) powered to determine whether ultrasound-facilitated, catheter-directed thrombolysis (USCDT) via the EKOS™ Endovascular System plus anticoagulation (AC) improves outcomes versus anticoagulation alone in acute intermediate-risk pulmonary embolism (PE). EKOS™ demonstrated superiority to anticoagulation alone for patients with intermediate-risk PE.

"The HI-PEITHO trial evaluated clear, clinically meaningful endpoints using rigorous patient enrollment criteria and demonstrated a definitive impact with the EKOS™ system over the standard of care for treating acute PE," said Dr. Michael R. Jaff, vice president and chief medical officer, Vascular Therapies, Boston Scientific. "For the first time, we have robust randomized clinical trial data available to inform treatment decisions by interventionalists and referring physicians and support consideration of EKOS™ plus anticoagulation as a first-line therapy."

HI-PEITHO is a joint research study led by Boston Scientific, in partnership with The PERT Consortium® and University Medical Center Mainz, to establish advanced therapy with EKOS™ as a first line treatment for intermediate-risk PE patients.

View the press release here