HOW CAN A PFO
LEAD TO STROKE?

Normally, the heart pumps blood into the lungs. There, blood cells receive oxygen, and blood clots get filtered out.

In people with a patent foramen ovale (PFO), blood and blood clots can bypass the lungs. Clots that move through the heart can get pumped to the brain and cause a stroke. This is called a PFO-associated stroke. Closing the PFO lowers a person’s risk of having another stroke.

AMPLATZER™ TALISMAN™
PFO OCCLUDER

3 questions to ask your doctor*:

Have I had all the testing I need to determine the cause of my stroke?
Did test results identify the cause of my stroke?
Was my stroke related to a PFO?

*Guidance from the American Academy of Neurology

LEARN MORE ABOUT PFO CLOSURE

Hear from patients
who've had PFO closure

Watch patient stories

UNDERSTAND YOUR TREATMENT OPTIONS

Learn about PFO treatment

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-2513605 v1.0 | 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.