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