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Structural Interventions

AMPLATZER PICCOLO™ OCCLUDER CLINICAL DATA

The only U.S. approved device specifically designed and indicated for Patent Ductus Arteriosus (PDA) closure in premature infants, 700g and up.

AMPLATZER PICCOLO™ OCCLUDER: PROVEN SAFETY FOR THE YOUNGEST INFANTS AND UP

The safety and efficacy of the Amplatzer Piccolo™ Occluder in patients weighing ≥ 700 grams was
studied in a 50-patient pivotal trial and in 150 additional patients under a continued access protocol. When combined, the study enrolled a total of 200 patients. At the time of the procedure, 100 patients weighed ≤ 2 kg and the other 100 patients weighed >2 kg.1

NEW PICCOLO 3-YEAR FOLLOW-UP DATA

95.5%1

Average
IMPLANT SUCCESS
99.0% for patients ≤ 2kg
92.0% for patients > 2kg

100%2


EFFECTIVE PDA CLOSURE
At 3-year follow-up
Only IDE patients included a 3 year echo.

>95.0%2


3-YEAR SURVIVAL
No deaths were directly attributed
to the procedure or device itself.

2.0%2


DEVICE RELATED 
SERIOUS ADVERSE EVENTS
At 3-year follow-up

CLICK THE LINK BELOW TO LEARN MORE ABOUT AMPLATZER PICCOLO™ OCCLUDER 3-YEAR DATA

Read the paper

MAT-2312397 v1.0 | Item approved for U.S. use only.

References
  1. Sathanandam SK, Gutfinger D, O’Brien L, et al. Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams. Catheter Cardiovasc Interv. 2020;96(6):1266-1276. doi: 10.1002/ccd.28973.
  2. Zahn, E. The Amplatzer Piccolo™ (ADOIIAS) U.S. Clinical Trial 3-Year Follow-up Report. Presented at: CSI Frankfurt; June 22-25, 2022
Important Safety Information
  • AMPLATZER PICCOLO™ OCCLUDER

  • 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.

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