HI-PEITHO Trial Delivers Statistically Significant Win
On March 28, 2026, Boston Scientific announced pivotal results from its global randomized HI-PEITHO trial, establishing its EKOS™ Endovascular System as a superior treatment for acute, intermediate-risk pulmonary embolism (PE). The study demonstrated a statistically significant reduction in adverse clinical events when the EKOS device was used with anticoagulation compared to the standard treatment of anticoagulation alone.
The findings carry substantial weight within the medical community, having been presented during a late-breaking clinical trial session at the American College of Cardiology's ACC.26 conference. Reinforcing the data's credibility, the results were simultaneously published in The New England Journal of Medicine, one of the world's most prestigious medical journals. This dual-platform release ensures the findings reach a broad audience of clinicians, hospital administrators, and investors, signaling a major clinical advancement.
EKOS Poised to Capture Pulmonary Embolism Market
By proving superiority over the existing treatment protocol, the HI-PEITHO trial results position the EKOS system to become the new standard of care for this patient group. This clinical validation provides a compelling reason for hospitals and physicians to adopt the device, directly challenging the efficacy of treatment with anticoagulants alone. The successful outcome is expected to drive significant revenue growth for Boston Scientific's Peripheral Interventions business and strengthen its competitive moat.
For investors, this development represents a key organic growth catalyst. The trial data provides Boston Scientific with a powerful marketing advantage and a clear clinical justification for premium pricing and broader insurance reimbursement. The ability to define a new, superior standard of care in a critical treatment area solidifies the company's long-term market leadership and offers a clear pathway to increased sales and market share in the lucrative endovascular device sector.