Portico Next Generation Approval Study

Exclusion Criteria

• •1. Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as evidenced on 12 Lead ECG) within 30 days prior to index procedure.
• •2. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to index procedure.
• •3. Blood dyscrasias as defined: leukopenia (WBC\<3000 mm3), acute anemia (Hb \< 9 g/dL), thrombocytopenia (platelet count \<50,000 cells/mm³). History of bleeding diathesis or coagulopathy
• •4. Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation
• •5. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).
• •6. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+).
• •7. Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic ring, severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT), severe (greater than or equal to 3+) mitral insufficiency, or severe mitral stenosis with pulmonary compromise.
• •8. Minimum access vessel diameter of \<5.0mm for small FlexNav™ Delivery System and \<5.5 mm for large FlexNav™ Delivery System