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Stroke Risk Reduction

Patent Foramen Ovale (PFO)

About 1 in 4 people have a hole in their heart called a patent foramen ovale (PFO). Before birth, all babies have a natural opening between the right and left sides of the heart called the foramen ovale, which allows blood and oxygen to bypass the lungs by flowing through the umbilical cord. This opening normally closes after birth, but in about 25% of people, it does not seal completely. 

When it remains open, it is called 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.

Patent Foramen Ovale

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

Foramen Ovale

FIGURE 1:
PRIOR TO BIRTH
 




FIGURE 2:
POST BIRTH NATURAL SEALING OF THE FORAMEN OVALE

Patent Foramen Ovale

FIGURE 3:
FORAMEN OVALE REMAINS OPEN, CREATING PFO

STROKE OVERVIEW

A stroke occurs when blood flow to the brain is blocked or disrupted, depriving brain cells of oxygen and causing damage. The most common type is an ischemic stroke, which happens when a blood clot blocks a vessel supplying the brain.

In many cases—about 25–30%—the exact cause of an ischemic stroke isn’t identified. One possible contributor is a patent foramen ovale (PFO), a small opening between the right and left sides of the heart.

Normally, blood returning to the heart is pumped to the lungs, where clots are filtered out. However, in people with a PFO, a clot can bypass the lungs, pass through the opening into the left side of the heart, and then travel to the brain. This can block blood flow and cause a stroke. This is known as a PFO-associated stroke. For some individuals, closing the PFO may reduce the risk of having another stroke.

Stroke

Amplatzer™ Talisman™ PFO Occluder

*Guidance from the American Academy of Neurology

Patent Foramen Ovale

PFO Treatment

If you or a loved one has a history of an ischemic stroke and 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-2612623 v4.0 | 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-2623300 v10.0  |   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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