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STRUCTURAL INTERVENTIONS

AMPLATZER™ SEPTAL OCCLUDER

The primary treatment option for atrial septal defects (ASD) is percutaneous, transcatheter closure, and Abbott’s Amplatzer™ Septal Occluder is the proven standard of care1,2—with more than 20 years of global clinical experience in ASD closure.3

FROM THE #1 COMPANY IN CONGENITAL OCCLUDERS3

The Amplatzer™ line not only pioneered structural heart defect occluder devices, it remains the leader in innovation and treatment worldwide. The Amplatzer Septal Occluder offers exceptional safety data, which is significant given that it is the most studied transcatheter ASD closure device on the market.6

The importance of treating patients with Atrial Septal Defects

Patients diagnosed with an ASD, who are indicated for closure with an Amplatzer™ Septal Occluder, exhibit both4:

  • Echocardiographic evidence of ostium secundum ASD
  • Clinical evidence of right ventricular (RV) volume overload (i.e., ratio of pulmonary to systemic flow > 1.5 or RV enlargement)
After receiving ASD closure with the Amplatzer Septal Occluder, Bao remarks

After receiving ASD closure with the Amplatzer Septal Occluder, Bao remarks:

“I feel better. And maybe (now) I can have more energy to play with my daughter.”

This testimonial relates an account of an individual’s response to the treatment. This patient’s account is genuine, typical and documented. However, it does not provide any indication, guide, warranty or guarantee as to the response other persons may have to the treatment. Responses to the treatment discussed can and do vary and are specific to the individual patient.

Patient Experience after Atrial Septal Defect Occlusion

Patients typically report symptom improvement after the closure of the ASD. In young children, growth rate can increase, and in children and young adults, LV filling improves. When younger patients are treated—those who have less chamber enlargement before repair—there is greater likelihood of normalization of RV size.6
 

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, approved in the U.S. 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.4

The Amplatzer Septal Occluder is designed for ASD closure:

  • Shaped-memory nitinol mesh that securely apposes both sides of the septal wall
  • A wide waist that centers the device and fills the ASD 
  • Polyester material that promotes occlusion and tissue in-growth
  • Can be recaptured and redeployed for precise placement4

The Amplatzer Septal Occluder has the widest range of device sizes, from 4mm to 38mm, enabling the treatment of the widest range of ASD defects.

Amplatzer Septal Occluder for ASD in the secundum position

Amplatzer™ Cribriform Multi-Fenestrated Septal Occluder

The Amplatzer™ Cribriform Occluder is a percutaneous, transcatheter, ASD device intended for the closure of multifenestrated (cribriform) ASDs.7 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.5

In many ways similar to the Amplatzer Septal Occluder, the Amplatzer Cribriform design features include: 

  • Self-expanding, double-disc device designed for closure of multi-fenestrated ASDs
  • Matched disc diameters that maximize coverage of multiple fenestrations
  • Ability to be easily recaptured and redeployed for optimal placement3

The Amplatzer Cribriform Occluder disc diameters range from 18 mm to 35 mm.

Amplatzer Cribriform Occluder is a percutaneous, transcatheter device for the closure of multifenestrated ASD
Abbott Amplatzer Portfolio App helps physicians determine which structural intervention device to use

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

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MAT-2008369 v4.0 | Item approved for U.S. use only.

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. Data on file at Abbott.
  4. Amplatzer Septal Occluder Instructions for Use.
  5. 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.
  6. Baumgartner, H., et al., 2020 ESC Guidelines for the management of adult congenital heart disease. Eur Heart J, 2021. 42(6): p. 563-645.
  7. Amplatzer Multi-Fenestrated Septal Occluder - Cribriform Instructions for Use.
Important Safety Information
  • Amplatzer Septal Occluder
  • AMPLATZER™ MULTI-FENESTRATED SEPTAL OCCLUDER – CRIBRIFORM

  • Rx Only

    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.

    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.

  • Rx Only

    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.

    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 that 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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