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 CLOSURE||98.4%|
|12-MONTH COMPLETE CLOSURE||98.6%|
|SERIOUS AND MAJOR ADVERSE EVENTS||1.3%|
*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
MAT-2115459 v3.0 | Item approved for U.S. use only.