Boston Scientific announced positive results from HI-PEITHO and CHAMPION-AF clinical trials on March 28, 2026, demonstrating superiority of EKOS and WATCHMAN FLX devices over standard care.
Key takeaways
HI-PEITHO trial (544 patients, intermediate-risk PE) met primary endpoint with EKOS plus anticoagulation superior to anticoagulation alone (4.0% vs 10.3%, P=0.005).
CHAMPION-AF trial (3,000 NVAF patients) met all endpoints with WATCHMAN FLX superior for bleeding safety vs NOACs (10.9% vs 19.0%, P<0.001) and non-inferior for efficacy (5.7% vs 4.8%).
HI-PEITHO results presented at ACC.26 and published in NEJM; EKOS showed 61% reduction in primary endpoint events.
CHAMPION-AF results presented at ACC.26 and published in NEJM; 99% procedural success rate across 141 sites.
Company plans submissions to expand WATCHMAN indications as first-line stroke risk reduction therapy.
Over 600,000 patients treated with WATCHMAN implants to date.