Penumbra (PEN) Transcatheter Cardiovascular Therapeutics (TCT) Conference 2025 summary

Key trial findings and clinical impact

• First randomized trial in over a decade comparing mechanical thrombectomy (CABT) to anticoagulation alone for intermediate high-risk pulmonary embolism, showing statistically superior reduction in RV/LV ratio with CABT.

• CABT group achieved normal RV/LV ratio in 39% of patients versus 13% in anticoagulation group; safety profiles were comparable between groups.

• Trial included 100 randomized patients from 767 screened, with strict inclusion criteria to ensure well-matched, symptomatic cohorts.

• The trial is considered foundational, expected to change treatment paradigms and guideline recommendations for this patient population.

• Functional and quality-of-life outcomes will be presented in future meetings, further informing clinical adoption.

Implications for guidelines, adoption, and education

• Evidence from this trial is sufficient for guideline recommendations; additional trials will strengthen the level of evidence but are not required for initial changes.

• Guideline updates depend on each society's cycle, but consensus is expected globally once evidence is reviewed.

• Broad clinical adoption will require education of non-interventionalists and multidisciplinary teams, leveraging initiatives like PRISM and PERT.

• The trial's design intentionally targeted non-interventional audiences to facilitate widespread dissemination and adoption.

• The technology's ease of use and strong safety profile are expected to encourage more interventionalists and centers to adopt the procedure.

Market opportunity and future directions

• Intermediate high-risk PE represents 15–25% of all PE cases in the U.S., translating to tens or hundreds of thousands of patients annually.

• The trial's results are expected to drive both new and existing physicians to adopt mechanical thrombectomy, with education as the primary lever.

• Cost-effectiveness analyses are underway and are anticipated to further support adoption by demonstrating long-term benefits.

• Expansion beyond centers with formal PERT teams is feasible, as multidisciplinary collaboration is common even without formal designation.

• Additional randomized trials and real-world data will continue to build on this foundation, with more functional and economic outcomes forthcoming.