Designed for flexibility, our innovative duct occluder options conform to a variety of duct sizes while achieving complete patent ductus arteriosus (PDA) closure from a pulmonary or aortic approach.
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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
INTERVENTIONAL DEVICE EXEMPTION AND PICCOLO CLINICAL TRIAL RESULTS
NEW 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
3-YEAR
SURVIVAL
No deaths were directly
attributed to the procedure
or device itself
MAJOR
COMPLICATIONS†
Through 180 days
4.2% for patients ≤ 2kg
0% for patients > 2kg
AMPLATZER™ DUCT OCCLUDER PDA CLOSURE CLINICAL DATA
The Amplatzer™ Duct Occluder was evaluated in a multicenter, non-randomized, pivotal study evaluating the clinical performance for PDA closure in 435 patients.3
| Acute Procedure Success* | 99.2% |
| 6-Month Complete Closure | 98.4% |
| 12-Month Complete Closure | 98.6% |
| Serious And Major Adverse Events | 98.6% |
AMPLATZER™ DUCT OCCLUDER II PDA CLOSURE CLINICAL DATA
The safety and efficacy of the Amplatzer™ Duct Occluder II were evaluated in a single-arm, multicenter study in 192 patients aged 6 months to < 18 years. The device was successfully implanted in 92.7% of patients, with complete closure in 98.2% of successful implantations. Serious adverse events were reported in 1.6% of patients.4
The study found that implantation was simple and the ability for retrograde aortic delivery revealed a statistically significant reduction in fluoroscopy time and therefore procedure-related radiation exposure.5
The Amplatzer™ Portfolio App helps physicians determine which Amplatzer Structural Interventions device to use by suggesting applicable devices based on respective Instructions for Use.
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- 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.
- Zahn E. The Amplatzer Piccolo™ (ADOIIAS) U.S. Clinical Trial 3-Year Follow-up Report. Presented at: CSI Frankfurt; June 22-25, 2022
- Amplatzer™ Duct Occluder Instructions for Use.
- Amplatzer™ Duct Occluder II Instructions for Use.
- Gruenstein DH, et al. Transcatheter closure of patent ductus arteriosus using the Amplatzer™ Duct Occluder II (ADO II). Catheter Cardiovasc Interv. 2017;89(6):1118-1128. doi.org/10.1002/ccd.26968.