Amplatzer™ Septal Occluder

Uniquely Designed
for ASD Closure

Two AMPLATZER ASD Closure Devices for Optimizing Patient Care

Abbott offers two devices for percutaneous, transcatheter ASD closure.
 

AMPLATZER™ Septal Occluder

The Amplatzer™ Septal Occluder, FDA approved since 2001, is intended for patients with an ASD in the secundum position or patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration.

The Amplatzer Septal Occluder has a wide connecting waist that centers the device and fills the ASD. This occluder—offering the widest range of ASD sizes—can treat defects from 3 mm to 38 mm.

AMPLATZER™ Multi-Fenestrated Septal Occluder - "Cribriform"

The Amplatzer™ Multi-Fenestrated Septal Occluder - "Cribriform" - is safe and effective for the closure of multifenestrated (cribriform) ASDs.1

Multiple, or fenestrated, ASDs that require closure are not uncommon. In fact, nearly 10% of patients with secundum-type ASD are found to have multifenestrated ASDs.1

In many ways similar to the Amplatzer Septal Occluder, the Amplatzer Cribriform Occluder consists of 2 uniformly sized discs with a very small connecting waist. The waist allows the device to cover a much larger fenestrated area of the atrial septum. This occluder’s disc diameters range from 18 mm to 35 mm.

The Amplatzer Cribriform Occluder is effective in treating a multiple-fenestrated atrial septum.

Designed for Quality, Safety, and Efficacy

Both types of Amplatzer Septal Occluders offer these unique features:

  • Discs that are designed to securely appose the septal wall on each side of the defect
  • Polyester material that promotes occlusion and tissue in-growth
  • Ability to be recaptured and redeployed to ensure precise device placement

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The Amplatzer App helps physicians determine which Amplatzer Structural Intervention device to use by suggesting applicable devices based on respective Instructions for Use.

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MAT-2012647 v1.0 | Item approved for Global use.

MAT-2008369 v1.0 | Item approved for U.S. use only.

References
  1. Cho MJ, Song J, Kim SJ, et al. Transcatheter closure of multiple atrial septal defects with the Amplatzer™ device. Korean Circ J. 2011;41:549-551.
Important safety information
  • Amplatzer Septal Occluder

    AMPLATZER™ SEPTAL OCCLUDER AND DELIVERY SYSTEM
    INDICATION 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.
    • 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™ MULTI-FENESTRATED SEPTAL OCCLUDER – CRIBRIFORM

    AMPLATZER™ MULTI-FENESTRATED SEPTAL OCCLUDER – CRIBRIFORM
    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 fenestrated 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 right ventricular 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 6 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 catheterization.
    • 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.
    • 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 vena cava 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

    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 EVENTS

    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

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