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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™ 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-2201735 v2.0 | Item approved for OUS use only.

References
  1. Amplatzer Duct Occluder Instructions for Use.
  2. Amplatzer Duct Occluder II Instructions for Use.
  3. 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 v20.0 | Item approved for OUS use only.

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