UNDERSTANDING
YOUR OPTIONS
FOR PFO TREATMENT

Talk to your doctor about all available
PFO treatment options

If you’ve had a stroke of unknown cause and have also been diagnosed with a patent foramen ovale (PFO), also known as a PFO-associated stroke, it’s important to talk to your doctor about how to reduce your risk of another stroke. Treatment options include medicine and a procedure to close your PFO.

PFO Closure with the
Amplatzer™ Talisman™
PFO Occluder

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.

Blood-Thinning
Medicine

Your doctor may prescribe medicine after your stroke. Sometimes an aspirin a day is recommended. Sometimes stronger medications called anticoagulants are recommended.

The goal of this medicine is to thin the blood and reduce your chance of having blood clots. No medicine can permanently close the hole in your heart.

Hear from patients
who've had PFO closure

Watch patient stories

GET MORE INFORMATION ON PFO CLOSURE

Find out how you can reduce your risk of another stroke with PFO closure.

LEARN MORE ABOUT PFO CLOSURE

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-2002547 v6.0 | Item approved for U.S. use only.

Important Safety Information

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.