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STRUCTURAL INTERVENTIONS

AMPLATZER™ DUCT OCCLUDERS

Designed for flexibility, our innovative duct occluder options conform to a variety of duct sizes while achieving complete patent ductus arteriosus (PDA) closure from a pulmonary or aortic approach.

INDUSTRY-LEADING AMPLATZER™
PDA OCCLUDERS1

The Amplatzer™ family of patent ductus arteriosus (PDA) closure occluders provides proven closure for a wide variety of patient morphologies. These devices share several Amplatzer characteristics:

  • Provide secure positioning in the ductus
  • Achieve complete closure
  • Promote tissue in-growth
  • Provide flexibility and conformability

PDA Closure in Infants


Constriction of the ductus arteriosus is a critical step in postnatal circulatory transition. If the ductus remains open, PDA occurs, resulting in left-to-right shunting that can create significant challenges, especially in premature infants.

Challenges include3:

  • Pulmonary over-circulation in lungs that are already under duress
  • Systemic hypoperfusion

As the only PDA closure solution indicated for premature infants ≥ 700g + ≥ 3 days old and proven to deliver safe and effective closure, Amplatzer Piccolo™ Occluder offers new opportunities to care for a wider range of patients than ever before.4

PDA Closure Guidelines in Adults


PDA closure is recommended if left atrial or left ventricular enlargement is present and attributable to the PDA with left-to-right shunt, pulmonary artery systolic pressure < 50% systemic, and pulmonary vascular resistance less than one-third systemic.5

PDA closure may be considered in the presence of a net left-to-right shunt if pulmonary artery systolic pressure is ≥ 50% systemic, and/or pulmonary vascular resistance is greater than one-third systemic.5

Transcatheter PDA closure—eg, with an Amplatzer™ ductus occluder—is the standard of care in most cases.6

Amplatzer Piccolo™ Occluder:
For PDA Closure in the smallest patients

The Amplatzer Piccolo™ Occluder, which delivers proven PDA closure for patients 700 g and up, provides the strength to occlude small ducts, while minimizing protrusion into surrounding pulmonary artery and descending aorta.4

Features include:

  • Low-profile retention discs and end screw are designed to minimize protrusion into the aorta and pulmonary artery
  • Symmetrical design for either pulmonary or aortic approach  
  • Tightly woven mesh to minimize residual shunt immediately after positioning
  • Flexible delivery wire for ease of deployment
  • Ability to be easily recaptured and redeployed for optimal placement9
Amplatzer Piccolo Occluder delivers PDA closure, occludes small ducts with minimal protrusion

Amplatzer™ Duct Occluder: For large PDA closure

Backed by over 15 years of performance in the U.S.,1 the Amplatzer™ Duct Occluder can accommodate large PDAs with a single device—which can aid in minimizing the complexity of the procedure.

Features include:

  • A conical shape that can help conform to tapering ducts
  • A retention skirt to prevent embolization

Treatment range:

  • Ductus diameter: 3.0-12.0 mm 
  • Ductus length: > 3.0 mm*

*The Amplatzer Duct Occluder can be used in any length defect as long as the device does not extend more than 3 mm into the pulmonary artery or does not occupy over half of the pulmonary artery lumen.
 

Amplatzer Duct Occluder for large PDA closure with a single device

Amplatzer™ Duct Occluder II:
Versatility to conform to a variety of PDAs

The Amplatzer™ Duct Occluder II is engineered using 2 articulating discs and multi-layered mesh that conforms to most classifications of PDAs.

Features include:

  • Symmetrical design so it can be introduced via pulmonary or aortic approach7
  • 6 planes of occlusion for full, cross-sectional coverage8
  • Fabric-free design allows for delivery through a low-profile catheter—while still achieving a very high occlusion rate7

Treatment range:

  • Ductus diameter: 2.5-5.5 mm
  • Ductus length: > 5.0-12.0 mm
     
Amplatzer™ Duct Occluder II uses multilayered mesh that conforms to most classifications of patent ductus arteriosus

MAT-2115460 v2.0 | Item approved for U.S. use only.

References
  1. Data on file at Abbott.
  2. Philip R, et al. Morphologic characterization of the patent ductus arteriosus in the premature infant and the choice of transcatheter occlusion device. Catheter Cardiovasc Interv. 2016;87(2):310-317. doi: 10.1002/ccd.26287.
  3. Schneider DJ, Moore JW. Patent ductus arteriosus. Circulation. 2006;114(17):1873-1918.
  4. Amplatzer Piccolo Occluder Instructions for Use.
  5. Stout KK, et al. 2018 AHA/ACC Guideline for the Management of Adults with Congenital Heart Disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2018;000:e000-e000. doi: 10.1161/CIR.0000000000000603.
  6. Baruteau AE, et al. Transcatheter closure of patent ductus arteriosus: past, present and future. Arch Cardiovasc Dis. 2014;107:122-132.
  7. Saliba Z, et al. The Amplatzer Duct Occluder II: a new device for percutaneous ductus arteriosus closure. J Interven Cardiol. 2009;22:496–502.
  8. Gruenstein DH, et al. Transcatheter closure of patent ductus arteriosus using the Amplatzer Duct Occluder II (ADO II). Catheter Cardiovasc Interv. 2017;89:1118–1128.  doi: 10.1002/ccd.26968.
  9. Data on File, 302350-001_G Amplatzer Duct Occluder CER.
Important Safety Information
  • AMPLATZER PICCOLO™ OCCLUDER
  • AMPLATZER™ DUCT OCCLUDER
  • AMPLATZER™ DUCT OCCLUDER II

  • Rx Only

    AMPLATZER PICCOLO™ OCCLUDER

    INDICATIONS AND USAGE

    The Amplatzer Piccolo™ Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical 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.

    POTENTIAL ADVERSE EVENTS

    Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to: Air embolus, Allergic reaction, Anemia, Anesthesia reactions, Apnea, Arrhythmia, Bleeding, Cardiac perforation, Cardiac tamponade, Chest pain, Device embolization, Device erosion, Death, Endocarditis, 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, Pleural effusion, Pulmonary embolism, Re-intervention for device removal, Respiratory distress, Stroke, Thrombus, Transient ischemic attack, Valvular regurgitation, Vascular access site injury, Vascular occlusion, Vessel perforation.

  • Rx Only

    AMPLATZER™ DUCT OCCLUDER

    INDICATIONS AND USAGE

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

    CONTRAINDICATIONS

    Patients weighing less than 6 kg; Patients less than 6 months of age; Presence of thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained; Active endocarditis or other infections producing bacteremia; Patients whose vasculature, through which access to the defect is gained, is inadequate to accommodate the appropriate sheath size; Patients with pulmonary hypertension with pulmonary vascular resistance of greater than 8 Wood units or Rp/Rs of greater than 0.4.

    POTENTIAL AND ADVERSE EVENTS

    Placement of the Amplatzer™ Duct Occluder involves using standard interventional cardiac catheterization techniques. The following events might occur from either the catheterization procedure or from the device: Air embolus; Allergic drug reaction; Allergic dye reaction; Anesthesia reactions; Apnea; Arrhythmia; Bacterial endocarditis; Bleeding; Brachial plexus injury; Chest pain; Death; Delivery system failure; Fever; Headache/migraine; Hypertension/hypotension; Myocardial infarction; Partial obstruction of aorta; Partial obstruction of pulmonary artery; Perforation of vessel or myocardium; Peripheral embolism; Stroke/transient ischemic attack; Thrombus; Valvular regurgitation; Vascular access site complications.

  • Rx Only

    AMPLATZER™ DUCT OCCLUDER II

    INDICATIONS AND USAGE

    The Amplatzer™ Duct Occluder II is a percutaneous transcatheter occlusion device 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.

    POTENTIAL AND 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; Vessel perforation.

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