PORTICO™ WITH FLEXNAV™ TAVI SYSTEM
Deliverability Redefined. A Future Optimized.
TAVI DELIVERABILITY TEST RESULTS

MAT-2107480 v3.0 | Item approved for U.S. use only.
Deliverability Redefined. A Future Optimized.
MAT-2107480 v3.0 | Item approved for U.S. use only.
PORTICO™ TRANSCATHETER
AORTIC VALVE IMPLANTATION SYSTEM
INDICATIONS
The Portico™ Transcatheter Aortic Valve Implantation System is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator).
CONTRAINDICATIONS
The valve is contraindicated for patients with inability to tolerate antiplatelet/anticoagulant therapy or nitinol alloy (nickel and titanium), or who have active infections, including endocarditis.
WARNINGS
Carefully read all warnings, precautions, and instructions for use for all components of the system before use. Failure to read and follow all instructions or failure to observe all stated warnings could cause serious injury or death to the patient.
PRECAUTIONS
Pre-Implantation Precautions
Implantation Precautions
Post-Implantation Precautions
POTENTIAL ADVERSE EVENTS
Adverse events potentially associated with the use of transcatheter bioprosthetic heart valves include but are not limited to:
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