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CONGENITAL
HEART DEFECTS

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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

AVERAGE
IMPLANT SUCCESS

99.0% for patients ≤ 2kg
92.0% for patients > 2kg

EFFECTIVE
PDA CLOSURE*

100% for patients ≤ 2kg
98.8% for patients > 2kg

6-MONTH
SURVIVAL

Overall survival for the IDE and CAP patients at 6 months
96.0% for patients ≤ 2kg
98.0% for patients > 2kg

MAJOR
COMPLICATIONS†

Through 180 days
4.2% for patients ≤ 2kg
0% for patients > 2kg

CAP=continued access protocol, IDE=investigational device exemption.
*Assessed by echocardiography and defined as the presence of either a grade 0 (none) or grade 1 (trivial) shunt.
†Major complications were defined as device or procedure-related adverse events resulting in death, a life-threatening adverse event, persistent or significant disability and/or surgical intervention.

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PICCOLO™ CLINICAL TRIAL SUMMARY

PICCOLO 3-YEAR FOLLOW-UP DATA

AVERAGE
IMPLANT SUCCESS

99.0% for patients ≤ 2kg
92.0% for patients > 2kg

EFFECTIVE
PDA CLOSURE*

At 3-year follow-up Only IDE patients included a 3 year echo

6-MONTH SURVIVAL

Overall survival for the IDE and
CAP patients at 6 months
96.0% for patients ≤ 2kg
98.0% for patients > 2kg

MAJOR COMPLICATIONS†

Through 180 days
4.2% for patients ≤ 2kg
0% for patients > 2kg

IDE=investigational device exemption
*Assessed by echocardiography and defined as the presence of either a grade 0 (none) or grade 1 (trivial) shunt.
†Major complications were defined as device or procedure-related adverse events resulting in death, a life-threatening adverse event, persistent or significant disability and/or surgical intervention.

INTERVENTIONAL DEVICE EXEMPTION AND PICCOLO CLINICAL TRIAL RESULTS

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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.org/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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