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Stay Informed
Stroke Risk Reduction

PFO Closure


If you have had a stroke of unknown cause and have also been diagnosed with a patent foramen ovale (PFO) you may have had a PFO-associated stroke. For people with a PFO-associated stroke, PFO closure with the Amplatzer™ Talisman™ PFO Occluder is a treatment option to reduce the risk of another stroke.

PFO Treatment Options

Discuss all treatment options with your doctor
Your doctor can describe the risks and benefits and help you decide which option is right for you.

Medications

BLOOD-THINNING
MEDICATION

Your doctor may prescribe blood-thinning medication to reduce your chance of having blood clots. Aspirin (taken daily) is the recommended medication for most patients to reduce the risk of having another ischemic stroke. Some physicians recommend stronger blood-thinning medications called anticoagulants.

Mitral Valve Repair Surgery

OPEN HEART SURGERY TO CLOSE THE PFO

Today, open heart surgery is rarely performed to close a PFO unless it is performed together with another surgery or the heart team determines that device closure with an occluder is not technically possible.1,2

PFO Closure with Amplatzer Talisman PFO

PFO CLOSURE
 

A PFO occluder is a device that can be placed in your heart close to the PFO through a minimally-invasive, catheter-based technique, and is designed to stop blood flow through the PFO.

Understanding PFO closure and the Amplatzer™ Talisman™ PFO occluder

Download the PFO treatment guide to learn more about the treatment options.

DOWNLOAD GUIDE

Watch these stories to learn how real-life patients have navigated their diagnosis, made treatment decisions, and returned to the activities they love. While every patient's experience is unique, their journeys may help you better understand what life can look like before and after PFO closure.

  • Christine Lee - USA

  • Alan Butcher - England

  • Tim Karniewich, USA

The Amplatzer Talisman PFO Occluder is a device that can be placed in your heart to close your PFO. The occluder stops blood clots from traveling through the PFO.

This reduces your risk of having another stroke. Guidelines from the American Academy of Neurology and the American Heart Association/American Stroke Association support PFO closure in more patients.

Watch the video to learn more about the PFO closure procedure.

Talk to your doctors to find out if PFO closure is right for you.

  • What happens during the PFO closure procedure?

    First you will receive a sedating medicine to help you relax. You will also receive a local anesthetic. Once you are relaxed and comfortable, your doctor will begin the procedure.

    Your doctor will make a small incision (cut) and insert a tube called a catheter into your groin area. The Amplatzer Talisman PFO Occluder travels inside the catheter. Your doctor will guide the catheter through your body to your heart.

    Then your doctor will place the Amplatzer Talisman PFO Occluder across your PFO. Cardiac imaging tools will help your doctor confirm that the occluder is in the right position before removing the catheter.

    Then your doctor will remove the catheters. The occluder will stay in your heart. You will be resting in the recovery room in about 2 hours.
     

  • What happens after the PFO closure procedure?

    You should expect to be home within 24 hours. Before you go home, your doctor will talk to you about your care, including any medication you may need to take. You may be prescribed aspirin (81 to 325 mg) and clopidogrel (75 mg) to be taken daily for 1 month after the procedure, followed by daily aspirin (81 to 325 mg) alone for at least 5 additional months. About 6 months after the Amplatzer Talisman PFO Occluder is implanted, your doctor will perform a test called an echocardiogram to see how you are responding.

    Regular check-ups with your doctor are very important. Call or see your doctor whenever you have questions or if you have any unusual problems, such as bleeding, pain, discomfort, or changes in your overall health.

    You will also be given an Amplatzer Talisman PFO Occluder Patient ID card. Please carry it with you at all times and tell other doctors that you have had the PFO closure procedure before any medical, dental, or MRI (magnetic resonance imaging) procedures. Failure to do so may result in health problems or damage to the PFO occluder.

Search for a doctor near you and book an appointment to answer any questions you may have about the Amplatzar Talisman PFO Occluder or procedure.

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The information provided is not intended for medical diagnosis or treatment or as a substitute for professional advice. Consult with a physician or qualified healthcare provider for appropriate medical advice.

MAT-2612670 v6.0 | Item approved for U.S. use only.

References
  1. Goldman Cecil Medicine Ch. 61 Congenital Heart Disease Adults
  2. Penn Medicine about Patent Foramen Ovale
  3. 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(11):1011-1021. doi: 10.1056/NEJMoa1705915
  4. Abbott (2018). Internal Sales Data 1996-2018.
Important Safety Information

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 v8.0  |   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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