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
99.0% for patients ≤ 2kg
92.0% for patients > 2kg
At 6 monts
100% for patients ≤ 2kg
98.8% for patients > 2kg
Overall survival for the IDE and CAP patients at 6 months
96.0% for patients ≤ 2kg
98.0% for patients > 2kg
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 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.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.