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Stroke Risk Reduction

Patent Foramen Ovale (PFO)

During development, prior to birth, a channel between the right and left sides of the heart called the foramen ovale, allows blood from veins to bypass the lungs. In about 25% of people, the foramen ovale does not close completely after birth. When the foramen ovale remains open, it is called a “patent foramen ovale” or a PFO. Typically, a PFO causes no problems. However, in some cases, it can allow a small amount of blood to pass from the right side of the heart to the left side of the heart.1

Download PFO treatment guide to learn more about patent foramen ovale (PFO) treatment options to reduce stroke risk.

The diagram below shows an open foramen ovale before birth, a closed foramen ovale after birth, and a patent foramen ovale after birth.

FIGURE 1:
PRIOR TO BIRTH
 

Foramen Ovale

FIGURE 2:
POST BIRTH NATURAL SEALING OF THE FORAMEN OVALE

FIGURE 3:
FORAMEN OVALE REMAINS OPEN, CREATING PFO

Patent Foramen Ovale

STROKE OVERVIEW

Strokes are caused by a sudden interruption in blood flow to a part of the brain or bleeding within the brain tissue. When this happens, brain cells are deprived of oxygen and begin to die, causing brain damage. When brain cells die during a stroke, the function controlled by that part of the brain, like speech or movement, may be impaired.

There are two major types of stroke: hemorrhagic stroke and ischemic stroke. A hemorrhagic stroke occurs when damaged blood vessels in the brain allow bleeding into the brain tissue resulting in swelling and pressure that damages the brain. An ischemic stroke occurs when a blockage develops in a blood vessel carrying blood to the brain.
 

Embolic Stroke of Unknown Cause

An embolic stroke of unknown cause is an ischemic stroke for which no definite cause is found. It is estimated that 25% - 30% of ischemic strokes are of unknown cause.

One possible factor that may have contributed to a stroke of unknown cause is the presence of a patent foramen ovale.

Stroke

HOW DOES
A PFO AFFECT STROKE RISK?

Blood clots in veins can develop for various reasons and travel to the right side of the heart. Normally, they are then pumped to the lungs, which act as a filter. However, a PFO can allow those clots to bypass the lungs and cross to the left side of the heart. From there, they can be pumped to the brain, causing a stroke.1

People who have a PFO and have had an embolic stroke of unknown cause may be at an increased risk for having a second stroke. In some people, a second stroke can be prevented by having the PFO closed.2

Patent Foramen Ovale

PFO TREATMENT

If you or a loved one has been diagnosed with a patent foramen ovale (PFO), it’s important to seek timely treatment since the condition increases the risk for stroke. Your doctor will discuss the best treatment option for you. Learn about treatment options to reduce stroke risk.

TREATMENT OPTIONS

MAT-2304811 v2.0 | Item approved for U.S. use only.

References
  1. American Heart Association. Patent foramen ovale (PFO). Accessed March 15, 2023. www.heart.org/en/health-topics/congenital-heart-defects/about-congenital-heart-defects/patent-foramen-ovale-pfo
  2. Messé SR, Gronseth GS, Kent DM, et al. Practice Advisory update summary: Patent foramen ovale and secondary stroke prevention. Neurology. 2020;94:876-885. doi: 10.1212/WNL.0000000000009443
Important Safety Information
  • AMPLATZER TALISMAN PFO

  • WHAT IS THE AMPLATZER™ TALISMAN™ PFO
    OCCLUDER APPROVED FOR?
    Available by prescription only.

    The Amplatzer™ Talisman™ PFO Occluder is a device that is placed in the heart during a minimally invasive, catheter-based procedure to close a patent foramen ovale (PFO) to reduce the risk of another stroke in patients who have already had a stroke that was found to be related to the PFO.

    WHO SHOULD NOT RECEIVE THE AMPLATZER™ TALISMAN™ PFO OCCLUDER?

    Patients who have any of the following conditions should not receive the Amplatzer™ Talisman™ PFO Occluder: blood clots in the heart or blood vessels; mass, vegetation, or tumor inside the heart; heart or veins that are too small for the appropriate sheath size; anatomy in which the Amplatzer™ Talisman™ PFO Occluder would interfere with other heart structures, such as valves or veins; other sources of right to left shunts, including atrial septal defect; active heart infection or other untreated infections; or inability to take anticoagulant or antiplatelet therapy.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE AMPLATZER™ TALISMAN™ PFO OCCLUDER?

    Potential adverse events that may occur during or after a procedure using this device include, but are not limited to: air bubble that blocks blood flow in a vessel; allergic reaction to anesthesia, contrast dye, medication, or metal; loss of regular heart rhythm; abnormal connection between an artery and a vein; bleeding; perforation of the heart muscle or vessels; blood or fluid build-up around the heart; blood clot formation over the device or in the heart, leg, or lung; chest pain; death; obstruction of a blood vessel by all or part of an implanted device that entered the blood stream; device erosion; infection or inflammation in the heart; injury to the esophagus; fever; headache or migraine; high or low blood pressure; heart attack; pacemaker implant; pain; blood leakage outside a vessel; intervention to remove the device; stroke; temporary lack of oxygen to the brain; abnormal backward flow of blood through a valve; injury to the incision site.

    WHAT ARE THE WARNINGS ASSOCIATED WITH THE AMPLATZER™ TALISMAN™ PFO OCCLUDER?

    Patients at increased risk for blood clots may be prescribed a blood thinning medication following the procedure. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies.

    Talk to your doctor to learn more about the risks associated with the Amplatzer™ Talisman™ PFO Occluder.

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MAT-2302755 v6.0  |   Item approved for U.S. use only.

Step 1

To implant the device, your doctor inserts a narrow tube into a vein in your upper leg.

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