Boston Scientific Corp. disclosed that its HI‑PEITHO global randomized trial showed a 61% reduction in the composite primary endpoint for intermediate‑risk pulmonary embolism patients treated with the EKOS Endovascular System plus anticoagulation versus anticoagulation alone. The event rate fell to 4.0% in the EKOS group compared with 10.3% for anticoagulation alone, and no major bleeding events were observed in either arm.
The company also presented the CHAMPION‑AF trial for its WATCHMAN FLX left‑atrial appendage closure device. In a 3,000‑patient study, WATCHMAN FLX achieved a 99% procedural success rate, met all primary and secondary safety and efficacy endpoints, and demonstrated non‑inferiority to oral anticoagulants for major bleeding at 36 months. The trial reported a 45% relative reduction in non‑procedural bleeding risk, underscoring the device’s safety profile.
These data suggest that the EKOS system could become a first‑line therapy for intermediate‑risk pulmonary embolism, potentially expanding its market share and revenue base. Likewise, WATCHMAN FLX’s performance positions it as a viable first‑line alternative to long‑term anticoagulation for stroke prevention in non‑valvular atrial fibrillation, which could drive adoption across electrophysiology and interventional cardiology practices.
"These highly anticipated findings underscore the clinical efficacy for patients treated with this therapy, while also demonstrating that treatment was not accompanied by an increased risk of major bleeding and offered the added benefit of a shorter hospital stay compared to patients treated with anticoagulation alone," said Dr. Stavros Konstantinides, principal investigator of the HI‑PEITHO trial. "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," added Dr. Michael R. Jaff, vice president and chief medical officer of Boston Scientific’s Vascular Therapies division.
"The success of the landmark CHAMPION‑AF trial represents a meaningful milestone that will undoubtedly transform the treatment approach to stroke risk reduction in a broader population of patients who historically have needed to rely on medication," said Dr. Martin Leon, study co‑chair and chief innovation officer of the Cardiovascular Data Science Center at Columbia University Medical Center. "These results should give clinicians confidence in the potential of the WATCHMAN FLX device to become a first‑line treatment option for reducing the risk of stroke for a rapidly growing number of patients with AF.",
Investors had been concerned about cautious 2026 guidance and weaker electrophysiology sales, which had weighed on the company’s valuation. The anticipation of the CHAMPION‑AF results, however, provided a positive catalyst that helped offset those headwinds and reinforced confidence in Boston Scientific’s product pipeline.
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