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TOOLS & RESOURCES

AMPLATZER™ PORTFOLIO APP

EXCELLENCE
AT YOUR FINGERTIPS

The Amplatzer™ Structural Interventions portfolio not only pioneered structural heart defect occluders, but also retains a leadership position in structural heart innovation and treatment worldwide, while advancing patient safety and providing physicians with easy-to-use solutions. After over two decades of clinical success, it remains the leader in innovation and treatment worldwide. We continue that innovation with the Amplatzer Portfolio App.

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

The Ampatzer Portfolio App offers:

Information that is always up to date
The ability to show every device available in your region
Availability weather you’re online or offline
Accessibility on smartphones and tablets
Translation in 7 languages

Always
Up to date

Shows every
product available
in your region

Accessible online
and offline

FOR SMARTPHONES
AND TABLETS

FREE*

*Data rates may apply

Abbott Amplatzer Portfolio App helps physicians determine which structural intervention device to use

GET THE AMPLATZER PORTFOLIO APP

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

App Store

Google Play

MAT-2301281 v1.0 | Item approved for U.S. use only.

Important Safety Information

Important Safety Information

AMPLATZER™ TALISMAN™ PFO OCCLUDER
INDICATION FOR USE

The Amplatzer™ Talisman™ 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 stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude other causes of ischemic stroke.
CONTRAINDICATIONS
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 intra-cardiac thrombus, mass, vegetation, or tumor. 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 required Amplatzer™ Talisman™ PFO device size would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins.
Patients with another source of right-to-left shunts, including an atrial septal defect and/or fenestrated septum.
Patients with active endocarditis or other untreated infections.
Patients who are unable to tolerate intra-procedural anticoagulation or post-procedural anti-platelet therapy.
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/toxic effect due to: anesthesia, contrast media, medication, or metal; Arrhythmia; Arteriovenous fistulae; Bleeding; Cardiac perforation; Cardiac tamponade; Chest pain; Death; Deep vein thrombosis; Device embolization; Device erosion; Endocarditis; Esophagus injury; Fever; Headache/migraine; Hematoma; Hypertension/hypotension; Infection; Myocardial infarction; Pacemaker placement secondary to PFO device closure; Pain; Pericardial effusion; Pericarditis; Peripheral embolism; Pseudoaneurysm; Pulmonary embolism; Reintervention for residual shunt/device removal; Stroke; Transient ischemic attack; Thrombus formation; Valvular regurgitation; Vascular access site injury; Vessel perforation.
AMPLATZER™ AMULET™ LEFT ATRIAL APPENDAGE OCCLUDER
INDICATION FOR USE

The Amplatzer™ Amulet™ Left Atrial Appendage Occluder is a percutaneous transcatheter device intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation and who are at increased risk for stroke and systemic embolism based on CHADS₂ or CHA₂DS₂-VASc scores, are suitable for short term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.
CONTRAINDICATIONS
The Amplatzer™ Amulet™ Left Atrial Appendage (LAA) Occluder is contraindicated for patients:
with the presence of intracardiac thrombus,
with active endocarditis or other infections producing bacteremia.
where placement of the device would interfere with any intracardiac or intravascular structures.
POTENTIAL ADVERSE EVENTS
Potential adverse events associated with the device or implant procedure include, but are not limited to, the following:
Air embolism
Airway trauma
Allergic reaction
Anemia
Anesthesia reaction (nausea, vasovagal reaction, confusion/altered mental status or other)
Arrhythmia
Atrial septal defect
Bleeding
Cardiac arrest
Cardiac tamponade
Chest pain/discomfort
Congestive heart failure
Death
Device embolization
Device erosion
Device malfunction
Device malposition
Device migration
Device-related thrombus
Fever
Hematuria
Hypertension/hypotension
Infection
Multi-organ failure
Myocardial infarction
Perforation
Pericardial effusion
Pleural effusion
Renal failure/dysfunction
Respiratory failure
Seizure
Significant residual flow
Stroke
Thrombocytopenia
Thromboembolism: peripheral and pulmonary
Thrombus formation
Transient ischemic attack
Valvular regurgitation/insufficiency
Vascular access site injury (hematoma, pseudoaneurysm, arteriovenous fistula, groin pain or other)
Vessel trauma/injury
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 COMPLICATIONS AND 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 regurgitatio
AMPLATZER PICCOLO^TM OCCLUDER
INDICATIONS AND USAGE

The AMPLATZER Piccolo^TM 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
AMPLATZER™ MUSCULAR VSD OCCLUDER
INDICATION 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
POTENTIAL COMPLICATIONS AND ADVERSE EVENTS
Potential adverse events may occur during or after a procedure using this device may include, but are not limited to:
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
AMPLATZER^TM DUCT OCCLUDER AND DELIVERY SYSTEM
INDICATIONS AND USAGE
The AMPLATZER^TM 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 Complications 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