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About the PFO Procedure

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Make stroke prevention a priority

If you have had a cryptogenic stroke, the fear of having another stroke can be overwhelming. With the Amplatzer™ PFO Occluder, your doctor may be able to significantly reduce the risk of stroke reoccurrence.

The Amplatzer™ PFO Occluder can help prevent another stroke

Patients who have had the PFO closure procedure have experienced up to a 97% reduction in their risk of recurring stroke.¹ A randomized trial showed a significantly lower risk of recurrent stroke with the Amplatzer™ PFO occluder than with medical therapy alone.² With a proven track record of more than 130,000 patients treated globally³ over 25 years, the Amplatzer™ PFO Occluder is relied upon by thousands of physicians around the world.

Risk reduction

97%
Patients experienced up to 97% risk reduction of recurring stoke after PFO closure procedure¹

Before the procedure

Be sure to talk with your doctor about any medication you may be taking, as they may advise you to adjust your medication before the procedure. Your doctor may tell you not to eat or drink anything after midnight prior to the procedure. You should arrange for a ride to and from the hospital, and ask someone to help you at home (if necessary).

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During the procedure

The PFO closure procedure will take place in a heart catheterization laboratory, where minimally invasive procedures are performed. Before beginning the procedure, you will receive a sedating medication to help you relax and a local anesthetic so that you don’t feel any significant discomfort. The catheter-based procedure involves making a tiny skin incision, typically in the right groin area, and inserting a small tube (called a catheter) to guide the Amplatzer™ PFO Occluder through the blood vessels to close the PFO within your heart.

Once the occluder is placed across the PFO, the cardiologist will carefully study its position using cardiac imaging tools. When the cardiologist is satisfied with the position of the Amplatzer™ PFO Occluder, it will be released to remain permanently in the heart, and all catheters will be removed. The procedure should last between one and two hours.

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The Amplatzer™ PFO Occluder significantly lowers the risk of a recurrent ischemic stroke.

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Questions about the procedure

How do I know which treatment option is right for me?

Doctors likely found your PFO when trying to find the cause of your stroke. Often, the cause of stroke is never known. These strokes are called cryptogenic (Crypto means hidden. Gen means cause.) Doctors are aware that a PFO can lead to a stroke. To reduce the risk of another stroke, your doctors may recommend closing your PFO with the Amplatzer™ PFO Occluder. More than 130,000 patients have received the Amplatzer PFO Occluder.1 The device has been proven safe and effective in many large studies.2,3

  1. Abbott data on file.
  2. Mas J-L, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017; 377: 1011-21.
  3. Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017; 377: 1022-32.
What risks are associated with the PFO closure procedure?

As with any medical procedure, there is a possibility of complications. The most serious risks include:

  • Blood clot in the heart, leg or lung, requiring long-term anticoagulation therapy
  • Blood or fluid build-up between the heart muscle and the sac that covers the heart, requiring a drainage procedure
  • Irregular and/or rapid heart rate (particularly atrial fibrillation)
  • Perforation of the heart muscle or vessels
  • Stroke (major or minor)
  • Death

Additional potential risks associated with the procedure or the occluder include:

  • Allergic reaction to anesthesia
  • Allergic reaction to the contrast dye used to visualize the heart during the procedure
  • Allergic reaction to a drug used during the procedure
  • Allergic metal reaction: Nitinol (nickel, titanium), platinum/iridium, stainless steel (chromium, iron, manganese, molybdenum, nickel)
  • Irregular heart rhythm
  • Bleeding
  • Blood clot on the occluder
  • Blood vessel blockage due to blood clots or air
  • Chest pain
  • Fever
  • Fluid buildup around lungs
  • Headache or migraine
  • Heart attack
  • Heart valve damage that interferes with valve closure
  • High or low blood pressure
  • Incomplete closure of PFO
  • Infection
  • Injury to the heart or vessels
  • Injury to the nerves in the arm or lower neck
  • Movement of the occluder from its position within the PFO or to other parts of the body
  • Sudden interruption of blood flow to an organ or body part
  • Surgery or intervention to remove the occluder
  • Trouble or inability to breathe
Who should not have the procedure?

The Amplatzer™ PFO Occluder is not suitable for patients who:

  • Have a tumor or blood clots at the site where the occluder will be placed or in the vessels through which it will be used to reach the heart
  • Have blood vessels too small to allow the delivery system to pass through
  • Have an anatomy in which the occluder would interfere with heart or vascular function
  • Have other types of heart defects
  • Have a heart infection
References
  1. Mas J-L, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017; 377: 1011-21
  2. Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017; 377: 1022-32
  3. Internal data. Data on-file at Abbott.
MAT-2002562 v3.0 | Item approved for OUS use only.

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