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PFO CLOSURE AND
STROKE RISK REDUCTION

Fear of having another stroke can be overwhelming. Especially when you don’t know what caused your first stroke and you know you are at risk for another stroke. Closing your patent foramen ovale (PFO) with the Amplatzer Talisman PFO Occluder is proven to reduce the risk of having another stroke. Guidelines from the American Academy of Neurology and the American Heart Association/American Stroke Association support PFO closure for carefully selected patients.

Multiple studies have shown that in patients who have had the PFO closure procedure along with medicine that reduces blood clots, the relative risk of having another stroke was reduced 59% compared to patients who only received medicine.¹ 

The Amplatzer Talisman PFO Occluder has been shown to be far more effective at lowering stroke risk than medicine alone.2 

More than 250,000 patients and thousands of physicians around the world have chosen the Amplatzer Talisman PFO Occluder to reduce stroke risk.3

HOW IS THE AMPLATZER TALISMAN PFO OCCLUDER IMPLANTED?

Find out what to expect during and after this minimally invasive procedure.

LEARN ABOUT THE PROCEDURE

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-2002549 v6.0 | Item approved for U.S. use only.

References
  1. Messé SR, Gronseth GS, Kent DM, et al. Practice Advisory update summary: Patent foramen ovale and secondary stroke prevention. Neurology. 2020;94:876-885.
     
  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. Abbott Data on file.
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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