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STRUCTURAL INTERVENTIONS

AMPLATZER™ DUCT OCCLUDERS CLINICAL DATA

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.

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

95.5%

Implant
success

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

99.4%

Effective Closure†

At 6 monts
100% for patients ≤ 2kg
98.8% for patients > 2kg

97.0%

6 month
Survival

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

2.1%

MAJOR
COMPLICATIONS**

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

*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, life-threatening adverse event, persistent or significant disability and/or surgical intervention.

AMPLATZER™ DUCT OCCLUDER PDA CLOSURE CLINICAL DATA 

The Amplatzer™ Duct Occluder was evaluated in a multi-center, non-randomized, pivotal study evaluating the clinical performance for PDA closure in 435 patients.2

ACUTE PROCEDURE SUCCESS*99.2%
6-MONTH COMPLETE CLOSURE98.4%
12-MONTH COMPLETE CLOSURE98.6%
SERIOUS AND MAJOR ADVERSE EVENTS1.3%

*Of the number of patients where the device was attempted, those who successfully received a device.

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.3

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.4

MAT-2201735 v1.0 | Item approved for Global 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. Amplatzer Duct Occluder Instructions for Use.
  3. Amplatzer Duct Occluder II Instructions for Use.
  4. Gruenstein DH, et al. Transcatheter closure of patent ductus arteriosus using the Amplatzer Duct Occluder II (ADO II). Catheter Cardiovasc Interv. 2017;89:1118-1128.  doi: 10.1002/ccd.26968.
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MAT-2000631 v14.0 | Item approved for OUS use only.

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