Structural Interventions

The Amplatzer portfolio of structural intervention occluders provides minimally invasive treatment options for the closure of congenital heart defects and for stroke risk reduction. The closure procedures are performed through a transcatheter approach, which prevents the need for open heart surgery and enables faster recovery times.

Structural Interventions: Congenital Heart Defects

Structural Interventions: Stroke Risk Reduction

References

1. Kashour TS, Latroche B, Elhoury ME, et al. Successful percutaneous closure of a secundum atrial septal defect through femoral approach in a patient with interrupted inferior vena cava. Congenit Heart Dis. 2010;5:620–623.
2. Tadros VX, Asgar AW. Transcatheter closure of atrial septal defects: an update on ASD occlusion devices. Card Interv Today. 2016; March-April.
3. Hoffman J, Kaplan S. The incidence of congential heart disease. J Am Coll Cardiol. 2002;39(12):1890-1900.
4. Amplatzer Muscular VSD Occluder Instructions for Use.
5. Data on file at Abbott.
6. Amplatzer Amulet LAA Occluder IFU.

Important Safety Information

 AMPLATZER™ DUCT OCCLUDER

Indications and Usage
The AMPLATZER™ Duct Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).

Contraindications

• Patients weighing less than 6 kg
• Patients less than 6 months of age
• 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
• Active endocarditis or other infections producing bacteremia
• Patients whose vasculature, through which access to the defect is gained, is inadequate to accommodate the appropriate sheath size
• Patients with pulmonary hypertension with pulmonary vascular resistance of greater than 8 Wood units or Rp/Rs of greater than 0.4

Warnings

• The device should be removed if greater than 3 mm extends into the pulmonary artery, or if more than half of the left pulmonary artery lumen is occupied by the device.
• There is limited clinical data for patients over 40 years of age.
• The AMPLATZER™ Duct Occluder and 180° Delivery System should only be used by those physicians trained in transcatheter defect closure techniques.
• Physicians must be prepared to deal with urgent situations which require removal of embolized devices that result in critical hemodynamic compromise. This includes the availability of an on-site surgeon.
• Embolized devices must be removed. Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within a sheath.
• Do not use if the sterile barrier has been compromised in any way.
• Do not release the AMPLATZER™ Duct Occluder from the delivery cable if the device does not conform to its original configuration or if the device position is unstable. Recapture the device and redeploy. If still unsatisfactory, recapture the device and replace with a new device.

Precautions
Handling
The AMPLATZER™ Duct Occluder and 180° Delivery System were sterilized with ethylene oxide and are for single use only. Do not reuse or resterilize. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.

Sizing
Accurate defect sizing is crucial and mandatory for AMPLATZER™ Duct Occluder device selection. Refer to Table 4 for sizing instructions.

Procedural

• This device contains 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 seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data is currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted. Some forms of nickel have also been associated with carcinogenicity (ability to cause cancer) in animal models. In humans, carcinogenicity has been demonstrated only through an inhalation route (breathing nickel in) which will not occur with this procedure.
• The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs before, during, and/or after the use of this device.

Post-implant

• Endocarditis prophylaxis is carried out for 6 months according to the recommendation of the American Heart Association. The decision to continue endocarditis prophylaxis beyond 6 months is at the discretion of the physician.
• Any patient who has a residual shunt will undergo an echo cardiographic evaluation of the residual shunt until complete closure of the defect has been confirmed.
• Lung perfusion scan should be completed if flow through is greater than 3 m/s, or if the Z-score is -2 for the left pulmonary artery diameter.

MR Conditional to 3.0 Tesla

• Through nonclinical testing, the AMPLATZER™ device has been known to be MR Conditional at field strengths of 3.0 tesla or less with a maximum whole-body-averaged specific absorption rate (SAR) of 3.83 W/kg at 1.5 tesla and 5.57 W/kg at 5.0 tesla for a 20-minute exposure to a B1 of 118μ tesla. The AMPLATZER™ device should not migrate in this MR environment. Nonclinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 tesla.
• In this testing, the device produced a temperature rise of 1.1°C at 1.5 tesla and 1.6°C at 5.0 tesla.
• MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.

Use in Specific Populations

• Pregnancy — Care should be taken to minimize the radiation exposure to the fetus and the mother.
• Nursing mothers — There has been no quantitative assessment of the presence of leachables in breast milk.

Potential Adverse Events

Placement of the AMPLATZER™ Duct Occluder involves using standard interventional cardiac catheterization techniques.

The following events might occur from either the catheterization procedure or from the device:

• Air embolus
• Allergic drug reaction
• Allergic dye reaction
• Anesthesia reactions
• Apnea
• Arrhythmia
• Bacterial endocarditis
• Bleeding
• Brachial plexus injury
• Chest pain
• Death
• Delivery system failure
• Fever
• Headache/migraine
• Hypertension/hypotension
• Myocardial infarction
• Partial obstruction of aorta
• Partial obstruction of pulmonary artery
• Perforation of vessel or myocardium
• Peripheral embolism
• Stroke/transient ischemic attack
• Thrombus
• Valvular regurgitation
• Vascular access site complications

 AMPLATZER™ MUSCULAR VSD OCCLUDER

Indications and Usage
The AMPLATZER™ Muscular VSD Occluder is indicated for use in patients with a complex ventricular septal defect (VSD) of significant size to warrant closure (large volume left-to right shunt, pulmonary hypertension, and/or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition.
High-risk anatomical factors for transatrial or transarterial surgical closure include patients:

• Requiring left ventriculotomy or an extensive right ventriculotomy.
• With a failed previous VSD closure.
• With multiple apical and/or anterior muscular VSDs (“Swiss cheese septum”).
• With posterior apical VSDs covered by trabeculae.

Contraindications
The AMPLATZER™ Muscular VSD Occluder is contraindicated for the following:

• Patients with defects less than 4 mm distance from the semilunar (aortic and pulmonary) and atrioventricular valves (mitral and tricuspid)
• Patients with severely increased pulmonary vascular resistance above 7 Wood units and a right-to-left shunt and documented irreversible pulmonary vascular disease
• Patients with perimembranous (close to the aortic valve) VSD
• Patients with post-infarction VSD
• Patients who weigh less than 5.2 kg. (Patients smaller than 5.2 kg were studied in the clinical trial, but due to poor outcome, these patients have been contraindicated for device placement. Data from these patients has not been included in the overall analysis.)
• Patients with sepsis (local/generalized)
• Patients with active bacterial infections
• Patients with contraindications to antiplatelet therapy or agents

Warnings

• The AMPLATZER™ Muscular VSD Occluder and delivery system should only be used by those physicians trained in transcatheter defect closure techniques.
• Physicians must be prepared to deal with urgent situations, such as device embolization, which require removal of the device. This includes the availability of an on-site surgeon.
• Embolized devices must be removed. Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within a sheath.
• Use on or before the last day of the expiration month noted on the product packaging.
• The device is sterilized using ethylene oxide and is for single use only. Do not reuse or resterilize. Attempts to resterilize the device may result in device malfunction, inadequate sterilization, or patient harm.
• Do not use the device if the packaging sterile barrier is open or damaged.
• Do not release the AMPLATZER™ Muscular VSD Occluder from the delivery cable if the device does not conform to its original configuration or if the device position is unstable. Recapture the device and redeploy. If still unsatisfactory, recapture the device and replace with a new device.
• Device closure in patients who have suffered a previous thromboembolic stroke should be discussed with the patient or family. In addition, consultation with a neurologist and hematologist is suggested to determine if the benefit of device closure outweighs the risk.

Precautions
Handling
Store in a dry place.

Sizing
Accurate defect sizing is crucial and mandatory for AMPLATZER™ Muscular VSD Occluder device selection. The VSD should be assessed and sized at end diastole by transesophogeal echocardiography (TEE) or angiography to determine the appropriate device size. Device selection should be 2 mm larger than the defect size.

Procedural

• This device contains 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 seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data is currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.
• The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs before, during, and/or after the use of this device.
• This device should only be used by physicians who have been trained in transcatheter techniques and who should determine which patients are suitable candidates for procedures using this device.
• Aspirin (eg, 81 mg or 325 mg) or an alternative antiplatelet/anticoagulant is recommended to be started at least 24 hours prior to the procedure. Cephalosporin therapy is optional.
• Maintain a recommended minimum active clotting time (ACT) of 200 seconds prior to device insertion and throughout the procedure.
• If TEE is used, the patient's esophogeal anatomy must be adequate for placement and manipulation of the TEE probe.
• Patients requiring multiple devices and/or concomitant catheterization procedures might require prolonged fluoroscopy times and multiple cineangiograms. The risks of radiation exposure (eg, increased cancer risk) should be discussed in detail with the patient or family and alternatives which do not involve radiation exposure should be reviewed.

Post-implant

• Patients should be treated with antiplatelet/anticoagulation therapy (such as aspirin) for 6 months post-implant. The decision to continue antiplatelet/anticoagulation therapy beyond 6 months is at the discretion of the physician.
• Endocarditis prophylaxis should be followed according to the American Heart Association recommendations.
• Any patient who has a residual shunt should undergo an echocardiographic evaluation of the residual shunt every 6 months until complete closure of the defect has been confirmed.
• Patients should be instructed to avoid strenuous activity for 1 month. Strenuous activities such as contact sports prior to 1 month after implant may cause the device to dislodge and embolize.

Use in Specific Populations

• Pregnancy - Care should be taken to minimize the radiation exposure to the fetus and the mother.
• Nursing mothers - There has been no quantitative assessment of the presence of leachables from the device/procedure in breast milk, and the risk to nursing mothers is unknown.

MR Conditional¹
Through non-clinical testing, AMPLATZER™ devices have been shown to be MR Conditional. A patient with an implanted AMPLATZER™ device can be scanned safely immediately after placement of the device under the following conditions:

• Static magnetic field of 3 tesla or less
• Spatial gradient magnetic field of 720 G/cm or less
• Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning

During testing, the device produced a clinically non-significant temperature rise at a maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning in a 3-tesla MR system using a transmit/receive body coil.
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.
^{1. MR Conditional as defined in ASTM F 2503-05.}

Potential Adverse Events
Potential adverse events may occur during or after a procedure using this device may include, but are not limited to:

• Air embolus
• Allergic drug reaction
• Allergic dye reaction
• Anemia
• Anesthesia reactions
• Apnea
• Arrhythmia
• Arterial pulse loss
• Atelectasis
• Bacterial endocarditis
• Blood loss requiring transfusion
• Brachial plexus injury
• Cardiac arrest
• Cardiomyopathy
• Chest pain
• Cyanosis
• Death
• Device embolization
• Device fracture
• Fever
• Headache/migraine
• Heart block
• Hypotension
• Myocardial infarction
• Perforation of the vessel or myocardium
• Peripheral embolism
• Stridor
• Stroke
• Subaortic stenosis
• Thrombus formation on device
• Vascular access site injury
• Venous thrombosis
• Vomiting

 AMPLATZER™ SEPTAL OCCLUDER

Indications for Use
The AMPLATZER™ Septal Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the occlusion of atrial septal defects (ASD) in secundum position or patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration. Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement).

Contraindications

• The AMPLATZER™ Septal Occluder is contraindicated for the following:
• Any patient known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery.
• Any patient known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.
• Any patient known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy, unless another antiplatelet agent can be administered for 6 months.
• Any patient known to have a demonstrated intracardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
• Any patient whose size (such as, too small for transesophageal echocardiography probe, catheter size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.
• Any patient where the margins of the defect are less than 5 mm to the coronary sinus, inferior vena cava rim, AV valves, or right upper lobe pulmonary vein.

Warnings

• Physicians must be prepared to deal with urgent situations, such as device embolization, which require removal of the device. This includes the availability of an on-site surgeon.
• Embolized devices must be removed as they may disrupt critical cardiac functions. Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within the sheath.
• Use on or before the expiration date noted on the product packaging.
• This device is sterilized using ethylene oxide and is for single use only. Do not reuse or resterilize. Attempts to resterilize the device may result in device malfunction, inadequate sterilization, or patient harm.
• Do not use the device if the packaging sterile barrier is open or damaged.
• Do not release the AMPLATZER™ Septal Occluder 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)). Recapture the device and redeploy. If still unsatisfactory, recapture the device and either replace with a new device or refer the patient for alternative treatment.
• Implantation of this device may not supplant the need for Coumadin‡ in patients with ASD and paradoxical emboli.
• The use of echocardiographic imaging (TTE, TEE, or ICE) is required.
• Balloon sizing should be used to size the atrial septal defect using a stop-flow technique. Do not inflate the balloon beyond the cessation of the shunt (such as, stop-flow). DO NOT OVERINFLATE.
• Patients with a retro-aortic rim of less than 5 mm in any echocardiographic plane, or patients in whom the device physically impinges on (i.e. indents or distorts) the aortic root, may be at increased risk of erosion.
• Do not select a device size greater than 1.5 times the echocardiographic-derived ASD diameter prior to balloon sizing.

Precautions

• The use of this device has not been studied in patients with patent foramen ovale.
• Use standard interventional cardiac catheterization techniques to place this device.
• Placement of the AMPLATZER™ Septal Occluder may impact future cardiac interventions, for example transeptal puncture and mitral valve repair.
• This device contains 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 seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data is currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.

Handling
Store in a dry place.

Procedural

• This device should only be used by physicians who have been trained in transcatheter techniques and who should determine which patients are suitable candidates for procedures using this device.
• The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs before, during, and/or after the use of this device.
• Aspirin (for example, 81 mg or 325 mg) or an alternative antiplatelet/anticoagulant is recommended to be started at least 24 hours prior to the procedure. Cephalosporin therapy is optional.
• Maintain a recommended minimum active clotting time (ACT) of 200 seconds prior to device insertion and throughout the procedure.
• If TEE is used, the patient's esophageal anatomy must be adequate for placement and manipulation of the TEE probe.

Post-implant

• Patients should take appropriate endocarditis prophylaxis for 6 months following device implantation. The decision to continue endocarditis prophylaxis beyond 6 months is at the discretion of the physician.
• Patients should be treated with antiplatelet/anticoagulation therapy (such as aspirin) for 6 months post-implant. The decision to continue antiplatelet/anticoagulation therapy beyond 6 months is at the discretion of the physician.
• Clinical follow-up with a cardiologist and echocardiograms are recommended at implant, 1 day post-implant, pre-discharge, and again at 1 week, 1 month, 6 months, and 12 months post-implant. Immediate follow-up with a cardiologist with the onset of any new symptoms suggestive of erosion or impending erosion, and routine clinical follow-up annually thereafter is also recommended.

Use in Specific Populations

• Pregnancy - Care should be taken to minimize the radiation exposure to the fetus and the mother.
• Nursing mothers - There has been no quantitative assessment of the presence of leachables from the device/procedure in breast milk, and the risk to nursing mothers is unknown.

MR Conditional to 3.0 Tesla
Caution should be used if an MRI is performed with a magnetic field of >3.0 tesla. Through non-clinical testing, the AMPLATZER™ device has been known to be MR Conditional at field strengths of 3.0 tesla or less with a maximum whole-body-averaged specific absorption rate (SAR) of 3.83 W/kg at 1.5 tesla and 5.57 W/kg at 5.0 tesla for a 20-minute exposure to a B1 of 118 μT. The AMPLATZER™ device should not migrate in this MR environment. Non-clinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 tesla.
In this testing, the device produced a temperature rise of 1.1°C at 1.5 tesla and 1.6°C at 5.0 tesla.
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.

Potential Adverse Events
Potential adverse events may occur during or after a procedure placing this device may include, but are not limited to:

• Air embolus
• Allergic dye reaction
• Anesthesia reactions
• Apnea
• Arrhythmia
• Cardiac tamponade
• Death
• Embolization
• Fever
• Hypertension/hypotension
• Infection including endocarditis
• Need for surgery
• Pericardial effusion
• Perforation of vessel or myocardium
• Pseudoaneurysm including blood loss requiring transfusion
• Tissue erosion
• Thrombus formation on discs
• Stroke
• Valvular regurgitation

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.
   

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