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WHAT IS A
PATENT FORAMEN OVALE
OR PFO?

AMPLATZER™ TALISMAN™ PFO OCCLUDER

Before birth, all babies have a hole in the heart called the foramen ovale. This hole allows babies to get blood and oxygen through the umbilical cord. The foramen ovale normally closes after birth. In about 25% of people, this hole doesn’t close all the way.¹ When the hole remains open, it’s called a patent foramen ovale, or a PFO.

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CAN PFO CAUSE STROKE?

Learn how

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-2513602 v1.0 | Item approved for U.S. use only.

References
  1. Kent DM, Thaler DE. Is patent foramen ovale a modifiable risk factor for stroke recurrence? Stroke. 2010;41(10 Suppl):S26-30. doi: 10.1161/STROKEAHA.110.595140
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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MAT-2003161 v10.0 | Item approved for U.S. use only.

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