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STRUCTURAL INTERVENTIONS

AMPLATZER PICCOLO™ OCCLUDER CLINICAL DATA

The only 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-2314095 v1.0 | Item approved for OUS 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
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MAT-2000631 v18.0 | Item approved for OUS use only.

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