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STRUCTURAL INTERVENTIONS

AMPLATZER™ DUCT OCCLUDERS CLINICAL DATA

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.

Clinical Data

AMPLATZER™ DUCT OCCLUDER PDA CLOSURE CLINICAL DATA

The Amplatzer™ Duct Occluder was evaluated in a multi-center, non-randomized, pivotal study evaluating the clinical performance for PDA closure in 435 patients.¹

ACUTE PROCEDURE SUCCESS*	99.2%
6-MONTH COMPLETE CLOSURE	98.4%
12-MONTH COMPLETE CLOSURE	98.6%
SERIOUS AND MAJOR ADVERSE EVENTS	1.3%

*Of the number of patients where the device was attempted, those who successfully received a device.

AMPLATZER™ DUCT OCCLUDER II PDA CLOSURE CLINICAL DATA

The safety and efficacy of the Amplatzer™ Duct Occluder II were evaluated in a single-arm, multicenter study in 192 patients aged 6 months to < 18 years. The device was successfully implanted in 92.7% of patients, with complete closure in 98.2% of successful implantations. Serious adverse events were reported in 1.6% of patients.²

The study found that implantation was simple and the ability for retrograde aortic delivery revealed a statistically significant reduction in fluoroscopy time and therefore procedure-related radiation exposure.³

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AMPLATZER PICCOLO™ OCCLUDER
CLINICAL DATA

MAT-2115459 v3.0 | Item approved for U.S. use only.

Important Safety Information

Important Safety Information

AMPLATZER™ DUCT OCCLUDER
AMPLATZER™ DUCT OCCLUDER II

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.