This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Portico Transcatheter Aortic Valve Implantation System
PMA Applicant: Abbott
Address: One St. Jude Medical Drive; St. Paul, MN 55117
Approval Date: September 17, 2021
Approval Letter: Link to Approval Letter
What is it?
The Portico Transcatheter Aortic Valve Implantation System is an artificial aortic heart valve replacement system that can be used without the need for an open-heart surgery. This implantation system consists of an artificial aortic heart valve and a delivery system (called the FlexNav Delivery System). The valve is made of natural tissue obtained from the hearts of cows and pigs that is attached to a self-expandable metal (nickel-titanium) frame for support.
How does it work?
The Portico Transcatheter Aortic Heart Valve is compressed and loaded inside the end of a tube-like device called a delivery catheter. The doctor inserts the delivery catheter and Portico transcatheter aortic valve into the body through a blood vessel, usually an artery in the leg, until it reaches the diseased aortic valve in the heart. The new valve is then released from the delivery catheter so that it will self-expand and anchor to the diseased valve. Once released, the delivery catheter is removed from the body and the valve will begin to immediately function by opening and closing like a door to guide blood flow in the correct direction.
When is it used?
The Portico Transcatheter Aortic Valve Implantation System is used in patients with diseased aortic heart valves due to calcium build up. This build up causes the valve to narrow (aortic stenosis) and restrict blood flow through the valve As the heart works harder to pump enough blood through a failing valve, it eventually weakens. This can lead to life-threatening heart problems such as fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), or cardiac arrest.
The Portico Transcatheter Aortic Valve Implantation System should only be used in patients who cannot undergo or are at high risk for open-heart surgery as determined by their heart team (including a cardiologist and a surgeon).
What will it accomplish?
The Portico Transcatheter Aortic Heart Valve can improve blood flow in the heart and provide an improved quality of life for patients with severe aortic stenosis who need replacement of their diseased valve but are considered to be at high risk for complications or death associated with an open-heart surgical procedure. In a clinical study, the risk of death or disabling stroke at one year was similar in patients receiving a Portico Transcatheter Aortic Heart Valve with the FlexNav Delivery System and those receiving commercially-available transcatheter aortic valves. One year after implantation, 85% of patients receiving a Portico Transcatheter Aortic Heart Valve showed improvement in their heart failure classification and were able to walk an average of 17 meters further in their six-minute walk evaluation.
Any procedure to replace the aortic valve carries the risk for serious complications. The serious complications associated with implanting a Portico Transcatheter Aortic Heart Valve include death, stroke, acute kidney injury, heart attack, bleeding, complications with the blood vessels used to insert the valve, and the need for a permanent pacemaker. For some patients, the risk of complications may be especially high. Patients should discuss the benefits and risks of this device with their heart team doctors, including the cardiologist and cardiac surgeon.
When should it not be used?
The Portico Transcatheter Aortic Valve Implantation System should not be used in:
- Patients with an active infection in the heart or elsewhere in the body
- Patients with known sensitivity or allergy to any metallic materials in the valve
- Patients who cannot tolerate blood thinning medications