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.

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