AMPLATZER™ TALISMAN™ PFO OCCLUDER

INDICATIONS 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.

WARNINGS

• Do not use an open or damaged pouch; do not use a damaged device.
• Patients who are at increased risk for venous thromboembolic events should be managed with thromboembolic risk reduction regimen after the PFO closure following standard of care.
• The safety and effectiveness of the Amplatzer™ Talisman™ PFO Occluder has not been established in patients with a hypercoagulable state.
• Prepare for situations that require percutaneous or surgical removal of this device. This includes availability of a surgeon and access to operating room.
• Embolized devices must be removed as they may disrupt critical cardiac functions. Do not remove an embolized occluder through intracardiac structures unless the occluder is fully recaptured inside a catheter or sheath.
• The Amplatzer™ Talisman™ PFO Occluder device consists of a nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to notify their physicians immediately if they suspect they are experiencing an allergic reaction such as difficulty breathing or inflammation of the face or throat. Some patients may also develop an allergy to nickel if this device is implanted.
• Transient hemodynamic compromise may be encountered during device placement, which may require fluid replacement or other medications as determined by the physician.
• Prior to device detachment, evaluate the position of the device relative to the free atrial wall and the aortic root using echocardiography.
• Use echocardiography to ensure that the device does not impinge on the free atrial wall or aortic root.
• Do not release the device from the delivery cable if the device does not conform to its original configuration, or if the device position is unstable or if the device interferes with any adjacent cardiac structure (such as Superior Vena Cava (SVC), Pulmonary Vein (PV), Mitral Valve (MV), Coronary Sinus (CS), aorta (AO)). If the device interferes with an adjacent cardiac structure, recapture the device and redeploy. If still unsatisfactory, recapture the device and either replace with a new device or consider alternative treatments.
• DO NOT use the Amplatzer™ Talisman™ PFO Occluder after the Use-by date stated on the package label.
• This device was sterilized with ethylene oxide and is for single use only. Never reuse or re-sterilize the system. Use of expired, reused, or re-sterilized devices may result in infection.
• This device should be used only by physicians who are trained in standard transcatheter techniques.

PRECAUTIONS FOR SPECIAL POPULATIONS

• Pregnancy: The safety and effectiveness of this occluder has not been established during pregnancy. Fluoroscopic x-ray guidance is used during placement of the device. The risk of increased X-ray exposure for patients who are pregnant must be weighed against the potential benefits of this technique.
• Nursing mother: The safety and effectiveness of this occluder has not been established in lactating mothers. There has been no quantitative assessment for the presence of leachables in breast milk.
• Pediatric Population: The safety and effectiveness of this occluder has not been established in a pediatric population.

PRECAUTIONS

• Aspirin (325 mg/day) (or alternative antiplatelet/anticoagulant, if patient has aspirin intolerance) is recommended to be started at least 24 hours prior to the procedure.
• Antibiotics should be administered peri-procedurally.
• Patients should be fully heparinized throughout the procedure using adequate dosing so as to keep the activated clotting time (ACT) greater than 200 seconds.

CAUTION: Intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE) is recommended as an aid in evaluating the PFO and placing the Amplatzer™ Talisman™ PFO Occluder. If TEE is used, the patient’s esophageal anatomy must be adequate for placement.

CAUTION: Be cautious when using fluoroscopic X-ray guidance, which may be used during placement of the device.

CAUTION: Do not use a power injection system to put contrast solution through the sheath.

The safety and effectiveness of the Amplatzer™ Talisman™ PFO Occluder has not been established in patients (with):

• Age less than 18 years or greater than 60 years because enrollment in the pivotal study (the RESPECT trial) was limited to patients 18 to 60 years old
• A hypercoagulable state including those with a positive test for a anticardiolipin antibody (IgG or IgM), Lupus anticoagulant, beta-2 glycoprotein-1 antibodies, or persistently elevated fasting plasma homocysteine despite medical therapy
• Unable to take antiplatelet therapy
• Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels associated with a ≥50% luminal stenosis
• Acute or recent (within 6 months) myocardial infarction or unstable angina
• Left ventricular aneurysm or akinesis
• Mitral valve stenosis or severe mitral regurgitation, irrespective of etiology
• Aortic valve stenosis (mean gradient greater than 40 mmHg) or severe aortic valve regurgitation
• Mitral or aortic valve vegetation or prosthesis
• Aortic arch plaques protruding greater than 4 mm into the aortic lumen
• Left ventricular dilated cardiomyopathy with left ventricular ejection fraction (LVEF) less than 35%
• Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter
• Uncontrolled hypertension or uncontrolled diabetes mellitus
• Diagnosis of lacunar infarct probably due to intrinsic small vessel as qualifying stroke event
• Arterial dissection as cause of stroke
• Index stroke of poor outcome (modified Rankin score greater than 3)
• Pregnancy at the time of implant
• Multi-organ failure

PATIENT COUNSELING INFORMATION
Physicians should review the following information when counseling patients about the Amplatzer™ Talisman™ PFO Occluder and the implant procedure:

• The safety and effectiveness of PFO closure with the Amplatzer™ Talisman™ PFO Occluder in combination with the required postimplant antiplatelet therapy.
• PFO closure with the Amplatzer™ Talisman™ PFO Occluder can only reduce the risk for a recurrent stroke due to a paradoxical embolism through a PFO.
  - With aging, there is an increased likelihood that non-PFO related risks for stroke may develop and cause a recurrent ischemic stroke independent of PFO closure.

• The procedural risks associated with Amplatzer™ Talisman™ PFO Occluder.
• The need for adherence to a defined adjunctive antithrombotic therapy following implantation of the Amplatzer™ Talisman™ PFO Occluder.
• Patients with a history of DVT or PE may benefit from continuation or resumption of anticoagulation therapy following implantation of the Amplatzer™ Talisman™ PFO Occluder to reduce the risk of recurrent DVT or PE.

It is recommended that the medical team (neurologist and cardiologist) and the patient engage in a shared decision-making process and discuss the risks and benefits of PFO closure in comparison to using antithrombotic therapy alone, while taking into account the patient’s values and preferences.

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