SIMPLICITY MATTERS.

With a variety of shapes, sizes and features that facilitate precise placement, our proven ASD occluders are designed specifically for ASD closure. Both designs offer the reliable performance and procedural simplicity and flexibility you expect from our products.

BAO’S STORY

Thanks to innovative research, manufacturing and some special help from her mother, the Amplatzer™ Septal Occluder has made a huge difference in Bao’s life, giving her the ability to be there for her family.

SAFETY IN NUMBERS

  • 98.5% closure rate with no significant residual shunt (less than 2 mm) at one-year follow-up1
  • Low major and minor complication rates: Post-production and long-term based on two-year follow-up1,3

DEMONSTRATED CLINICAL EXPERIENCE

The Amplatzer Septal Occluder is an extensively studied transcatheter ASD closure device in the marketplace today with more than 17 years of demonstrated clinical experience. The following three studies, taken together, cover over 1,500 patient-years of device experience.1-3

1998–2001
US PIVOTAL TRIAL

This study was conducted to determine the safety and efficacy of transcatheter atrial septal defect closure involving 442 device-closure patients and 911.5 total patient-years of device experience.1

US PIVOTAL TRIAL

2004–2007
MAGIC ATRIAL SEPTAL DEFECT STUDY

This study evaluated the initial safety and results of unrestricted multi-institution routine use of the Amplatzer Septal Occluder in 478 patients.2

MAGIC ATRIAL SEPTAL DEFECT STUDY

2008–2012
AMPLATZER SEPTAL OCCLUDER POST-APPROVAL STUDY

This study is evaluating the long-term safety and efficacy of the Amplatzer Septal Occluder. The results below are from 1,000 patients reported in July 2011. 3

ATRIAL SEPTAL DEFECTS (ASD)

An atrial septal defect (ASD) is a hole in the septum between the atria. ASDs are one of the most common congenital heart defects seen in pediatric cardiology and often occur in conjunction with other cardiac defects.4,5

AMPLATZER™ SEPTAL OCCLUDER

Minimally invasive transcatheter closure is the primary option for secundum atrial septal defects (ASD).4 The Amplatzer Septal Occluder is designed to appose the septal wall on each side of the defect and create a platform for tissue in-growth after implantation.

DESIGNED FOR ASD CLOSURE

  • Shaped-memory Nitinol mesh securely apposes both sides of the septal wall
  • A wide waist centers the device and fills the ASD
  • Polyester material promotes occlusion and tissue in-growth
  • Device can be recaptured and redeployed for precise placement
Septal Occluder

AMPLATZER CRIBRIFORM MULTI-FENESTRATED SEPTAL OCCLUDER

The Amplatzer Cribriform Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the closure of multi-fenestrated (cribriform) ASD.

EXCELLENT PRODUCT DESIGN

  • Self-expanding, double-disc device designed for closure of multi-fenestrated atrial septal defects
  • Matched disc diameters maximize coverage of multiple fenestrations
  • Device can be easily recaptured and redeployed for optimal placement
  • Nitinol and interwoven polyester promote occlusion and tissue in-growth
The AMPLATZER™ Cribriform Occluder
REFERENCES:

1. Du ZD, Hijazi ZM, Kleinman CS, Silverman NH, Larntz K; Amplatzer Investigators. Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults: results of a multicenter nonrandomized trial. J Am Coll Cardiol. 2002;39:1836–1844. doi: 10.1016/S0735-1097(02)01862-4.
2. Everett, A. D., Jennings, J., Sibinga, E., Owada, C., Lim, D. S., Cheatham, J., … Ringel, R. (2009). Community use of the Amplatzer atrial septal defect occluder: Results of the multicenter MAGIC atrial septal defect study. Pediatric Cardiology, 30(3), 240-247. http://dx.doi.org/10.1007/s00246-008-9325-x
3. Turner DR, Owada CY, Sang CJ, Kahn M, Lim S (2017). Closure of secundum atrial septal defects with the Amplatzer septal occluder: a prospective, multicenter, post-approval study. Circ Cardiovasc Interv. 2017;10:e004212. DOI: 10.1161/CIRCINTERVENTIONS.116.004212.
4. Moake, L., & Ramaciotti, C., Atrial Septal Defect Treatment Options (2005). AACN Clinical Issues, 16(2), 252-266.
5. McMahon, C. J., Feltes, T. F., Fraley, J. K., Bricker, J. T., Grifka, R. G., Tortoriello, T. A.,…Bezold, L. I. (2002). Natural history of growth of secundum atrial septal defects and implications for transcatheter closure. Heart, 87(3), 256-259.

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