The Amplatzer Family of Duct Occluders offers an extensive line of devices and a simple treatment option for the closure of patent ductus arteriosus (PDA). Amplatzer™ Duct Occluders are designed to occlude PDAs of various shapes and sizes. With an easy-to-perform deployment procedure, the implanting physician can be confident in placing the device with precision.
The Amplatzer™ Duct Occluder is designed to accommodate large PDAs with a single device — which may reduce the complexity of the procedure.
The Amplatzer™ Duct Occluder II conforms to a variety of ducts while achieving complete closure from a pulmonary or aortic approach.1
The Amplatzer Piccolo™ Occluder, is designed to occlude small ducts in patients 700g and up, including neonates and infants.
Amplatzer Duct Occluders are flexible and conformable and can be securely positioned in the ductus for complete closure. They are constructed of Nitinol mesh and the Amplatzer Duct Occluder also has polyester material.
|Model/Reorder Number||Device Diameter at Descending Aorta (mm)||Device Diameter at Pulmonary Artery (mm)||Retention Skirt Diameter (mm)||Device Length (mm)|
|Model/Reorder Number||Waist Diameter (mm)||Device Length (mm)||Disc Diameter (mm)|
|Model/Reorder Number||Waist Diameter (mm) [A]||Length betweek discs (mm) [B]||Disc Diameter (mm) [C]||Recommended Sheath Size|
|9-PDAP-03-02-L||3||2||4.00||4 F; 90° Curve|
|9-PDAP-03-04-L||3||4||4.00||4 F; 90° Curve|
|9-PDAP-03-06-L||3||6||4.00||4 F; 90° Curve|
|9-PDAP-04-02-L||4||2||5.25||4 F; 90° Curve|
|9-PDAP-04-04-L||4||4||5.25||4 F; 90° Curve|
|9-PDAP-04-06-L||4||6||5.25||4 F; 90° Curve|
|9-PDAP-05-02-L||5||2||6.50||4 F; 90° Curve|
|9-PDAP-05-04-L||5||4||6.50||4 F; 90° Curve|
|9-PDAP-05-06-L||5||6||6.50||4 F; 90° Curve|
Indications and Usage
The Amplatzer Piccolo™ Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).
Non-clinical testing has demonstrated that the Amplatzer Piccolo™ Occluder is MR Conditional. A patient with the Amplatzer Piccolo™ Occluder can be safely scanned in an MR system under the following conditions:
Under the scan conditions defined above, the device is expected to produce a maximum temperature rise of less than or equal to 3ºC after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends approximately 9 mm from the Amplatzer Piccolo™ Occluder when imaged with a gradient echo pulse sequence and a 3.0T MRI System.
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.