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Understanding the connection
between PFO and stroke

Chances are, you learned that you have a patent foramen ovale (PFO) after you had an ischemic stroke. You are not alone. Nearly half of people whose strokes have no known cause also have a PFO. Three things you should know about PFO and stroke:
1. Having a PFO can lead to stroke.
2. One stroke increases the risk of having another stroke.
3. Closing a PFO reduces the risk of having another stroke.

LEARN MORE ABOUT PFO  DOWNLOAD THE BROCHURE

After Christine Lee’s stroke at age 33, her neurologist ordered a transesophageal echocardiogram to look for a PFO. Nearly 6 months after her first stroke, she had a TIA. Her neurologist then made a referral to an interventional cardiologist, and he recommended she get the PFO closure procedure within 7 days.

"I’ve had so many emails from readers who say their neurologist won’t make that referral to an interventional cardiologist. They just won’t. They want to know the name of my cardiologist, because they’re so desperate.”

— Christine Lee, USA

More patient stories

AMPLATZER™ TALISMAN™
PFO OCCLUDER

With the Amplatzer™ Talisman™ PFO Occluder, your doctor may be able to significantly reduce your risk of another stroke. Watch how the procedure works.

Reduce your risk of another stroke

You can take charge of reducing your risk. Talk to your doctor about lifestyle changes, medicine, and PFO closure.

FIND A PHYSICIAN/CENTER

MAT-2002543 v6.0 | Item approved for U.S. use only.

Important Safety Information

Rx Only

AMPLATZER™ TALISMAN™ PFO OCCLUDER

INDICATION FOR USE


The Amplatzer™ Talisman™ PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude other causes of ischemic stroke.

CONTRAINDICATIONS

Presence of thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained; Patients with intra-cardiac thrombus, mass, vegetation, or tumor; Patients whose vasculature, through which access to the PFO is gained, is inadequate to accommodate the appropriate sheath size; Patients with anatomy in which the required Amplatzer™ Talisman™ PFO device size would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins; Patients with another source of right-to-left shunts, including an atrial septal defect and/or fenestrated septum; Patients with active endocarditis or other untreated infections; Patients who are unable to tolerate intra-procedural anticoagulation or post-procedural anti-platelet therapy.

POTENTIAL ADVERSE EVENTS

Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to: Air embolus; Allergic reaction/toxic effect due to: anesthesia, contrast media, medication, or metal; Arrhythmia; Arteriovenous fistulae; Bleeding; Cardiac perforation; Cardiac tamponade; Chest pain; Death; Deep vein thrombosis; Device embolization; Device erosion; Endocarditis; Esophagus injury; Fever; Headache/migraine; Hematoma; Hypertension/hypotension; Infection; Myocardial infarction; Pacemaker placement secondary to PFO device closure; Pain; Pericardial effusion; Pericarditis; Peripheral embolism; Pseudoaneurysm; Pulmonary embolism; Reintervention for residual shunt/device removal; Stroke; Transient ischemic attack; Thrombus formation; Valvular regurgitation; Vascular access site injury; Vessel perforation.

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CAUTION: Product(s) intended for use by or under the direction of a physician. Prior to use, reference to the Instructions for Use, inside the product carton (when available) or at www.eifu.abbott for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
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MAT-2003161 v10.0 | Item approved for U.S. use only.

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