This is a pilot study of the Flow Medical Catheter, a catheter-based device used to deliver clot-dissolving medication directly to a blood clot in the lungs (pulmonary embolism). The study evaluates whether the device can be used safely and as intended in adults with intermediate-risk acute pulmonary embolism. All participants receive treatment with the study device; there is no comparison group.
Age 18 to 75 years, inclusive.
Clinical signs and/or symptoms consistent with acute PE with symptom onset ≤14 days prior to baseline CTPA.
CTPA demonstrating acute PE with a filling defect in at least one main or lobar pulmonary artery.
RV/LV diameter ratio ≥0.9 on baseline CTPA (site read acceptable for eligibility determination).
High-risk (massive) PE: Sustained SBP <90 mmHg for ≥15 consecutive minutes, >40 mmHg drop from baseline, vasopressor requirement, or cardiac arrest requiring cardiopulmonary resuscitation during the immediate hospitalization.
Respiratory insufficiency: FiO₂ requirement >40% or >6 LPM supplemental oxygen to maintain SpO₂ >90%.
Prior PE: Prior PE ≤180 days from index procedure.
Any prior intracranial hemorrhage (no time limit)