Boston Scientific (BSX) American College of Cardiology 75th Annual Scientific Session and Expo summary

Key clinical trial results and innovation pipeline

• HI-PEITHO trial showed EkoSonic/EKOS system plus anticoagulation significantly reduced adverse outcomes and primary endpoint events by 61% in intermediate-risk pulmonary embolism patients, with no increase in major bleeding or intracranial hemorrhage at 7 and 30 days compared to anticoagulation alone.

• CHAMPION-AF trial demonstrated WATCHMAN FLX met all primary and secondary endpoints, showing non-inferiority for efficacy and superiority for safety versus NOACs, with a 34% relative risk reduction in bleeding and a 45% reduction in non-procedural bleeding at 36 months.

• WATCHMAN FLX arm had an annualized stroke and systemic embolism rate of 1.1%, comparable to pivotal DOAC trials, and showed statistical superiority in net clinical benefit over anticoagulation.

• Clinical implications suggest WATCHMAN FLX may be considered as an alternative to NOACs for suitable atrial fibrillation patients, supporting shared decision-making and potential updates to standard of care.

• Ongoing and future trials (Elite AF, OPTION, SIMPLAAFY, ASAP-TOO) aim to expand indications, improve device performance, and support further market growth.

Market outlook, strategy, and growth drivers

• Positive clinical data and anticipated guideline updates are expected to expand the addressable market for atrial fibrillation therapies from $2B to over $6B by 2030, with the indicated patient population projected to grow from 5 million to 20 million globally.

• Expanded reimbursement, evolving clinical guidelines, and regulatory submissions are projected to drive approximately 20% market growth through the long-range plan.

• International growth will depend on updates to guidelines and reimbursement policies, especially outside the U.S.

• New device generations, such as WATCHMAN Elite and the fourth-generation WATCHMAN, are designed to address complex anatomies and enhance procedural outcomes, with commercialization targeted for 2028.

• The company is advancing multiple clinical programs and working with professional societies for interim guideline updates and expanded CMS reimbursement.

Clinical and real-world impact

• Over 60 million people worldwide are affected by atrial fibrillation, with a significant portion at increased stroke risk.

• Real-world data highlight challenges with oral anticoagulant adherence, which increases stroke risk by over 50% for non-adherent patients, and real-world adherence to NOACs is around 60%, much lower than in trials.

• Cost-effectiveness and patient preference for a one-time procedure over lifelong medication are expected to influence adoption.

• HI-PEITHO trial results and clinical trial outcomes may inform future updates to pulmonary embolism treatment guidelines and support more informed decision-making.

• The company is actively engaging with the clinical community to communicate the benefits and safety of the WATCHMAN FLX device.