Penumbra Inc.
The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).
Inclusion Criteria: 1. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less 2. RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram 3. Frontline endovascular treatment with the Indigo Aspiration System per IFU 4. Patient is ≥ 18 years of age 5. Informed consent obtained per Institutional Review Board/Ethics Committee requirements Exclusion Criteria: 1. Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin) 2. Stage IV (metastatic) cancer, active lung cancer or previous history of surger…
Indigo Aspiration System