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 months
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-2115459 v2.0 | Item approved for U.S. use only.

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MAT-2004021 v11.0  |   Item approved for U.S. use only.

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