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ABOUT THE PFO CLOSURE
PROCEDURE

First you will receive a sedating medicine to help you relax. You will also receive a local anesthetic. Once you are relaxed and comfortable, your doctor will begin the procedure. 

Your doctor will make a small incision (cut) and insert a tube called a catheter into your groin area. The Amplatzer Talisman PFO Occluder travels inside the catheter. Your doctor will guide the catheter through your body to your heart. 

Then your doctor will place the Amplatzer Talisman PFO Occluder across your PFO. Cardiac imaging tools will help your doctor confirm that the occluder is in the right position before removing the catheter. 

Then your doctor will remove the catheters. The occluder will stay in your heart. You will be resting in the recovery room in about 2 hours.

You should expect to be home within 24 hours. Before you go home, your doctor will talk to you about your care, including any medication you may need to take. You may be prescribed aspirin (81 to 325 mg) and clopidogrel (75 mg) to be taken daily for 1 month after the procedure, followed by daily aspirin (81 to 325 mg) alone for at least 5 additional months.

About 6 months after the Amplatzer Talisman PFO Occluder is implanted, your doctor will perform a test called an echocardiogram to see how you are responding.

Regular check-ups with your doctor are very important. Call or see your doctor whenever you have questions or if you have any unusual problems, such as bleeding, pain, discomfort, or changes in your overall health.

You will also be given an Amplatzer Talisman PFO Occluder Patient ID card. Please carry it with you at all times and tell other doctors that you have had the PFO closure procedure before any medical, dental, or MRI (magnetic resonance imaging) procedures. Failure to do so may result in health problems or damage to the PFO occluder.

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-2513616 v1.0 | 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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MAT-2003161 v10.0 | Item approved for U.S. use only.

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