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™ 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.1

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.2

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.3

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AMPLATZER PICCOLO™ OCCLUDER
CLINICAL DATA

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MAT-2115459 v3.0 | Item approved for U.S. use only.

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