20 Years of Amplatzer Leadership
Heart

THE LEADING INTERVENTION PORTFOLIO FOR CONFIDENT OUTCOMES

  • The broadest structural heart intervention portfolio
  • A relentless focus on advancing patient safety
  • An unmatched track record
    – Two decades of experience
    – >1.25M implanted devices1

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OVER 20 YEARS OF AMPLATZER LEADERSHIP

With an unmatched track record, innovative manufacturing and a relentless focus on advancing patient safety, our proven surgical and transcatheter options help your structural heart patients at every state of life.”

REFERENCE: 
1. Abbott (2018). Internal Sales Data 1996-2018.

 

IMPORTANT SAFETY INFORMATION

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

 

  • Patients who are allergic to nickel may have an allergic reaction to this device.
  • 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.

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; Stroke; Tissue erosion; Thrombus formation on discs; Valvular regurgitation

 

AMPLATZER™ CRIBRIFORM OCCLUDER
INDICATIONS FOR USE

The AMPLATZER™ Cribriform Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the closure of multifenestrated (cribriform) atrial septal defects (ASD). 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™ Cribriform Occluder is contraindicated for the following:

  • Treatment of patients with patent foramen ovale (PFO) defects. This device has not been studied in patients with PFO defects.
  • Patients known to have extensive congenital cardiac anomaly, which can only be, adequately repaired by way of cardiac surgery.
  • Patients known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.
  • Patients known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy unless another anti-platelet agent can be administered for 61 months.
  • Patients known to have demonstrated intracardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
  • Patients whose size, (such as, too small for transesophageal echocardiography (TEE) probe, catheter size, vasculature size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac cathet1e11ization.
  • Any patient where the radius of the device is greater than the distance from the central defect to the aortic root or superior vena cava.
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 last day of the expiration month noted on the product packaging.
  • 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™ Cribriform 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.
  • Implantation of this device may not supplant the need for Coumadin in patients with ASD and paradoxical emboli.
  • The use of transthoracic, transesophageal, or intracardiac echocardiographic imaging (TTE, TEE, or ICE) is required.
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.
  • 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.

Patient Selection  
Certain patients may be at higher risk for complications such as tissue erosion and device embolization. If higher risk patients have devices implanted, closer follow-up is warranted (see “Post-procedure Instructions” on page 9). Higher risk patients include the following:

  • Patients with deformation of the device at the aortic root
  • Patients with high defects (minimal aortic and superior rims)
  • Patients with less than a 9-mm distance from the central defect to the aortic root or superior venacava orifice

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.
  • 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.

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
Through nonclinical testing, the AMPLATZER™ Septal Occluder has been shown 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.O tesla for a 20-minute exposure to a Bl of 118 μT. The AMPLATZER™ Septal Occluder should not migrate in this MR environment. The 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 may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.

ADVERSE EVENT

Observed Adverse Events — Tissue Erosion/Perforation
The reported incidence of tissue erosion/perforation is approximately 1 in 1,000 patients treated with the AMPLATZER™ Septal Occluder. Tissue erosion, while rare, has led to cardiac tamponade and death. Tissue erosion/perforation refers to the erosion or abrasion of the tissue of the atrium primarily in the area of the roof of the atrium near the aorta.

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; Brachial plexus injury; Cardiac perforation; Death; Device collapse due to structural failure; Device embolization; Device removal (due to embolization or misplacement); Erosion; Fever; Headache/migraines; Hematoma/pseudoaneurysm including blood loss requiring transfusion; Hypertension; Hypotension; Infection including endocarditis; Infectious endocarditis; Pericardial effusion; Perforation of vessel or myocardium; Phrenic nerve injury; Stroke/transient ischemic attack; Thrombus formation on the device surface with the risk of subsequent embolization; Valvular regurgitation; Vascular access site complications

 

AMPLAZTER™ DUCT OCCLUDER
INTENDED FOR USE

The AMPLAZTER™ Duct Occluder is a percutaneous transcatheter occlusion intended for the non-surgical 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. In addition to the above observed adverse events, the following are potential adverse events listed in alphabetical order that were not observed in the clinical study.
The following events might occur from either the catheterization procedure or from the device:

Air embolus; Allergic dye reaction; Allergic drug 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™ DUCT OCCLUDER II
INTENDED FOR USE

The AMPLAZTER™ Duct Occluder II is a percutaneous transcatheter occlusion intended for the non-surgical closure of patent ductus arteriosus.

CONTRAINDICATIONS

The AMPLATZER™ Duct Occluder II is contraindicated for the following:

  • Patients weighing less than 6 kg
  • Patients less than 6 months of age
  • Patients with a window-type patent ductus arteriosus (ie, length less than 3mm)
  • Patients with an active infection
  • Patients with thrombus at the intended site of implant
  • Patients with pulmonary hypertension with pulmonary vascular resistance of greater than 8 Wood units or Rp/Rs of greater than 0.4
  • Patients with patent ductus arteriosus greater than 12 mm in length by angiography
  • Patients with patent ductus arteriosus greater than 5.5 mm in diameter by angiography
WARNINGS
  • Patients at greater risk of complications can include:
    • Patients with descending aorta < 10 mm in diameter
    • Patients with cardiac anomalies requiring surgical or interventional correction
    • Patients with have had more than 2 lower respiratory infections within the last year
  • Do not release the occluder from the delivery wire if the occluder does not conform to its original configuration or if the occluder position is unstable. Recapture the occluder and redeploy. If still unsatisfactory, recapture the occluder and replace with a new occluder.
  • The AMPLATZER™ Duct Occluder II should only be used by physicians trained in transcatheter defect closure techniques.
  • Physicians must have an on-site surgeon available in the event the surgical removal of an occluder
    is required.
  • Embolized occluders must be removed. Embolized occluders should not be withdrawn through intracardiac structures unless they have been adequately collapsed within a catheter.
  • This device has not been studied in patients older than 18 years of age.
PRECAUTIONS
  • For single use only. Do not reuse or re-sterilize.
  • This device was sterilized with ethylene oxide and is for single use only. Do not use or re-sterilize this device. Attempts to re-sterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
  • Use before the expiration date noted on the product packaging.
  • Patients should have an activated clotting time (ACT) of greater than 200 sec prior to device replacement.
  • The AMPLATZER™ Duct Occluder II 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 are currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.
  • 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.
  • Store in a dry place.
  • Do not use if the packaging sterile barrier is opened or damaged.
  • Do not use contrast power injection with
    delivery catheter.
MR CONDITIONAL

St. Jude Medical’s AMPLATZER™ Duct Occluder II device is manufactured of chemically etched nitinol wire, 80% platinum 20% iridium marker band and a 316L end screw.
Non-clinical testing has demonstrated that the AMPLATZER™ Duct Occluder II device is MR-Conditional. Patients can be scanned safely immediately after implantation under the following conditions:

  • Static magnetic field of 1.5 Tesla (1.5T) or 3.0 Tesla (3.0T).
  • Maximum spatial gradient field less than or equal to 30 T/m.
  • Maximum whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning.

In non-clinical testing with body coil excitation, the AMPLATZER™ Duct Occluder II device produced a differential temperature rise of less than or equal to 3.65°C when exposed to a maximum average whole body specific absorption rate (SAR) of 3.35 W/kg for 15 minutes of scanning in a 3.0 Tesla MR system (Siemens™ MAGNETOM Espree™, SYNGO™ MR B17 software, Erlangen, Germany). Scaling of the SAR and observed heating indicates that average whole body SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than or equal to approximately 1.0°C in Normal Operating Mode.

In non-clinical testing with body coil excitation, the AMPLATZER™ Duct Occluder II device produced a differential temperature rise of less than or equal to 1.91°C when exposed to a maximum average whole body specific absorption rate (SAR) of 2.80 W/kg for 15 minutes of scanning in a 1.5 Tesla MR system (Siemens™ MAGNETOM Espree™, SYNGO™ MR B17 software, Erlangen, Germany). Scaling of the SAR and observed heating indicates that average whole body SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than or equal to approximately 1.0°C in Normal Operating Mode.

MR Image quality may be compromised if the area of interest is the same or relatively close to the
position of the device. Therefore, it may be necessary to optimize the MR imaging parameters for the presence of this implant.

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 dye reaction; Allergic drug reaction; Anesthesia reactions; Apnea; Arrhythmia; Bacterial endocarditis; Bleeding; Cardiac perforation; Cardiac tamponade; Chest pain; Device embolization; Device erosion; Death; Fever; Headache/migraine; Hypertension; Hypotension; Myocardial infarction; Palpitations; Pericardial effusion; Pericarditis; Peripheral embolism; Pleural effusion; Pulmonary embolism; Reintervention for device removal; Stroke; Transient ischemic attack; Thrombus; Valvular regurgitation; Vascular access site injury; and Vessel perforation.

 

AMPLAZTER PICCOLO™ OCCLUDER
INTENDED FOR USE

The AMPLAZTER Piccolo™ Occluder is a percutaneous transcatheter occlusion intended for the non-surgical closure of a patent ductus arteriosus (PDA).

CONTRAINDICATIONS
  • Weight < 700 grams at time of the procedure
  • Age < 3 days at time of procedure
  • Coarctation of the aorta
  • Left pulmonary artery stenosis
  • Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension
  • Intracardiac thrombus that may interfere with the implant procedure
  • Active infection requiring treatment at the time of implant
  • Patients with a PDA length smaller than 3 mm
  • Patients with a PDA diameter that is greater than 4 mm at the narrowest portion
WARNINGS
  • This device was sterilized with ethylene oxide and is for single use only. Do not reuse or re-sterilize this device. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
  • Do not use the device if the sterile package is open or damaged.
  • Use on or before the last day of the expiration month that is printed on the product packaging label.
  • Patients who are allergic to nickel can have an allergic reaction to this device.
  • Prepare for situations that require the removal of this device. Preparation includes access to a transcatheter snare kit and an on-site surgeon.
  • Accurate measurements of the ductus are crucial for correct occluder size selection.
  • Do not release the occluder from the delivery wire if either a retention disc protrudes into the pulmonary artery or aorta; or if the position of the occluder is not stable.
  • Remove embolized devices. Do not remove an embolized occluder through intracardiac structures unless the occluder is fully recaptured inside a catheter.
PRECAUTIONS
  • This device should be used only by physicians who are trained in standard transcatheter techniques. Determine which patients are candidates for procedures that use this device.
  • The physician should exercise clinical judgment in situations that involve the use of anticoagulants and antiplatelet drugs before, during, and/or after the use of this device.
  • Patients should have an activated clotting time (ACT) of greater than 200 sec prior to device placement, unless the patient has a significant risk for bleeding and is unable to be anti-coagulated.
  • The device may be delivered via an anterograde (venous) or a retrograde (arterial) approach. However, in small infants (≤2 kg), the device should be delivered using the anterograde (venous) approach since small infants are at an increased risk for arterial injury.
  • The AMPLATZER Piccolo™ Occluder 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 following implant. 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 seek immediate medical attention if there is suspicion of an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data are currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.

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.

Handling

  • Store in a dry place.
  • Do not use contrast power injection with delivery catheter.
POTENTIAL ADVERSE EVENTS

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

Air embolus; Allergic dye reaction; Allergic drug reaction; Anesthesia reactions; Apnea; Arrhythmia; Bacterial endocarditis; Bleeding; Cardiac perforation; Cardiac tamponade; Chest pain; Device embolization; Device erosion; Death; Fever; Headache/migraine; Hemolysis; Hematoma; Hypertension; Hypotension; Infection; Myocardial infarction; Palpitations; Partial obstruction of aorta; Partial obstruction of pulmonary artery; Pericardial effusion; Pericarditis; Peripheral embolism; Re-intervention for device removal; Respiratory distress; Stroke; Thrombus; Transient ischemic attack; Thrombus; Valvular regurgitation; Vascular access site injury; Vascular occlusion; Vessel perforation.

 

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.

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

1. MR Conditional as defined in ASTM F 2503-05.

 

AMPLATZER™ POST-INFARCT MUSCULAR VSD OCCLUDER
INDICATIONS AND USAGE

The AMPLATZER™ Post-infarct Muscular VSD Occluder is percutaneous transcatheter occlusion device intended for closure of post-myocardial infarct muscular VSDs in patients who are not satisfactory surgical candidates.

CONTRAINDICATIONS

The AMPLATZER™ Post-infarct Muscular VSD Occluder is contraindicated for the following:

  • Patients with perimembranous VSDs or a VSDs close to the aortic or mitral valve
  • Patients with congenital muscular VSDs
  • Patients with the 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 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 known to have active sepsis 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
WARNINGS
  • The AMPLATZER™ Post-infarct Muscular VSD Occluder should only be used by 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. CAUTION: 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 the device if the packaging sterile barrier is open or damaged.
  • 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 release the AMPLATZER™ Post-infarct 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 it with a new device.
  • Remove the dilator and sheath from the patient slowly to prevent an ingress of air.
PRECAUTIONS

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 120 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; and therefore, 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 are 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

  • Use standard interventional cardiovascular catheterization techniques when using AMPLATZER™ products.
  • This device should only be used by physicians who have been trained in transcatheter techniques. The physician 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 (3–5 mg/kg/day) is to be started at least 24 hours prior to the procedure. Cephalosporin therapy is optional.
  • Transesophageal echocardiography (TEE) or similar imaging equipment is recommended as an aid in placing the device. If TEE is used, the patient’s esophageal anatomy must be adequate for placement and manipulation of the TEE probe.

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.
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; Anemia; Anesthesia reactions; Apnea; Arrhythmia; Arterial pulse loss; Atelectasis; Bacterial endocarditis; Bleeding; Brachial plexus injury; Cardiac arrest; Chest pain; Cyanosis; Death; Device embolization; Device fracture; Fever; Headache/migraine; Heart block; Heart failure; Hemolysis; Hypertension; Hypotension; Left ventricular aneurysm; Myocardial infarction;  Perforation of the vessel or myocardium; Peripheral embolism; Renal insufficiency; Respiratory arrest; Sepsis; Stridor; Stroke/TIA; Sub-aortic stenosis; Thrombocytopenia; Thrombus; Valvular regurgitation/insufficiency; Vascular access site complications; Venous thrombosis; Vomiting

 

AMPLATZER™ PFO OCCLLUDERr
INDICATIONS AND USAGE

The AMPLATZER™ 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 cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.

CONTRAINDICATIONS
  • Patients with intra-cardiac mass, vegetation, tumor or thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the PFO is gained.
  • 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 AMPLATZER™ PFO device size required would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins.
  • Patients with other source of right-to-left shunts, including an atrial septal defect and/or fenestrated septum.
  • Patients with active endocarditis or other untreated infections.
WARNINGS
  • 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.
  • Do not use this device if the sterile package is open or damaged.
  • Prepare for situations that require percutaneous or surgical removal of this device. This includes availability of a surgeon.
  • 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.
  • Patients who are allergic to nickel can have an allergic reaction to this device.
  • This device should be used only by physicians who are trained in standard transcatheter techniques.
  • Transient hemodynamic compromise may be encountered during device placement, which may require fluid replacement or other medications as determined by the physician.
  • 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 refer the patient for alternative treatment.
  • Ensure there is sufficient distance from the PFO to the aortic root or SVC (typically defined as 9 mm or greater as measured by echo). See Figure 6. and Figure 7.
PRECAUTIONS
  • The safety and effectiveness of the AMPLATZER™ 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
  • Use on or before the last day of the expiration month that is printed on the product packaging label.
  • This device was sterilized with ethylene oxide and is for single use only. Do not reuse or re-sterilize this device. Attempts to re-sterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
  • The AMPLATZER™ 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.
  • Store in a dry place.
  • Pregnancy – Minimize radiation exposure to the fetus and the mother.
  • Nursing mothers – There has been no quantitative assessment for the presence of leachables in breast milk.
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 drug reaction; Allergic dye reaction; Allergic metal reaction: Nitinol (nickel, titanium), platinum/iridium, stainless steel (chromium, iron, manganese, molybdenum, nickel); Anesthesia reactions; Apnea; Arrhythmia; Bacterial endocarditis; Bleeding ; Brachial plexus injury; Cardiac perforation; Cardiac tamponade; Cardiac thrombus; Chest pain; Device embolization; Device erosion; Deep vein thrombosis; Death; Endocarditis; Esophagus injury; Fever; Headache/migraine; Hypertension/hypotension; Myocardial infarction; Pacemaker placement secondary to PFO device closure; Palpitations; Pericardial effusion; Pericardial tamponade; Pericarditis; Peripheral embolism; Pleural effusion; Pulmonary embolism; Reintervention for residual shunt/device removal; Sepsis; Stroke; Transient ischemic attack; Thrombus; Valvular regurgitation; Vascular access site injury; Vessel perforation