Objective
Evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism who have received treatment with the FlowTriever System compared to an established performance goal.
Design
Prospective, multicenter, non-randomized, parallel group, observational study | Three Arms: FlowTriever, Context, and Prior Therapy
Primary Endpoint
Composite all-cause mortality, bailout, clinical deterioration, major bleeding
Study Population
Up to 20 US Sites
71 FlowTriever Patients
> 71 Context Arm Patients (cap 142 pts)
Additional patients will be enrolled in the Prior Therapy Arm
Duration of Subject Follow-up
Patients followed through hospital discharge