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STRUCTURAL INTERVENTIONS

AMPLATZER™ VENTRICULAR SEPTAL DEFECT OCCLUDERS CLINICAL DATA

Ventricular septal defects (VSDs) are the most commonly found congenital heart defect.² Our Amplatzer™ VSD portfolio includes occluders specifically designed to close complex VSDs in patients considered to be too high risk for standard surgical repair.

Clinical Data

AMPLATZER™ VSD OCCLUDER DEMONSTRATED CLOSURE SUCCESS IN PATIENTS WITH VSD

The Amplatzer™ Muscular VSD Occluder was evaluated in a prospective, non-randomized, multi-center clinical study in 38 patients considered to be high risk for standard surgical repair of muscular VSD.¹

AMPLATZER MUSCULAR VSD OCCLUDER¹
ACUTE PROCEDURE SUCCESS RATE*	76.3%
6-MONTH CLOSURE RATE*	93.6%
12-MONTH CLOSURE RATE*	93.3%
24-MONTH CLOSURE RATE*	100.0%
MAJOR ADVERSE EVENTS AT 24 HOURS	41.0%

*Patients who had a shunt ≤ 2 mm at follow-up interval as assessed by investigator.

Amplatzer™ Post-Infarct VSD Occluder Clinical Data

The safety and effectiveness of the AMPLATZER™ P.I. Muscular VSD Occluder were evaluated in 44 post-myocardial infarction VSD patients.²

AMPLATZER P.I. MUSCULAR VSD OCCLUDER²
TECHNICAL SUCCESS*	95.5%
ACUTE PROCEDURE SUCCESS RATE^†	59.1%
1-MONTH SUCCESS RATE^‡	66.7%
MAJOR ADVERSE EVENTS	34.1%

*Patients in which device placement was attempted and a device was successfully deployed in a defect during a catheterization at some point during the study.
^†Successful closure of the defect was defined as ≤ 2-mm residual shunt, but may include shunts up to 2.9 mm. Rate is per patients seen.
^‡Successful closure of the defect was defined as ≤ 2-mm residual shunt. Rate is per patients seen.

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-2115461 v2.0 | Item approved for U.S. use only.

Important Safety Information

Important Safety Information

AMPLATZER™ Muscular VSD Occluder
AMPLATZER™ Post-infarct Muscular VSD Occluder

Rx Only
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 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 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.
Rx Only
AMPLATZER™ P.I. MUSCULAR VSD OCCLUDER
INDICATIONS AND USAGE

The Amplatzer™ Post-infarct Muscular VSD Occluder is a percutaneous transcatheter occlusion device intended for closure of post-myocardial infarct muscular VSDs in patients who are not satisfactory surgical candidates.
CONTRAINDICATIONS
The Amplatzer™ Post-infarct Muscular VSD Occluder is contraindicated for the following: Patients with perimembranous VSDs or a VSDs close to the aortic or mitral valve; Patients with congenital muscular VSDs; Patients with the 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 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 known to have active sepsis 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.
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 reaction; Anemia; Anesthesia reaction; Apnea; Arrhythmia; Arterial pulse loss; Atelectasis; Bacterial endocarditis; Bleeding; Brachial plexus injury; Cardiac arrest; Cardiomyopathy; Cyanosis; Chest pain; Death; Device embolization; Device fracture; Fever; Headache/migraine; Heart block; Heart failure; Hemolysis; Hypertension; Hypotension; Left ventricular aneurysm; Myocardial infarction; Perforation of vessel or myocardium; Peripheral embolism; Renal insufficiency; Respiratory arrest; Sepsis; Stridor; Stroke/TIA; Sub-aortic stenosis; Thrombocytopenia; Thrombus; Valvular regurgitation/insufficiency; Vascular access site complications; Venous thrombosis; Vomiting.