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AMPLATZER™
VENTRICULAR SEPTAL
DEFECT OCCLUDERS
STRUCTURAL INTERVENTIONS

 

Ventricular septal defects (VSDs) are the most commonly found congenital
heart defect.2 Our Amplatzer™ VSD portfolio includes occluders specifically
designed to close complex VSDs in patients considered to be too high risk for
standard surgical repair.

AMPLATZER™ MUSCULAR VSD OCCLUDER DEMONSTRATED CLOSURE SUCCESS IN PATIENTS WITH VSD

The Amplatzer™ Muscular VSD Occluder was evaluated in a prospective, non-randomized, multi-center clinical study in 38 patients considered to be high risk for standard surgical repair of muscular VSD.1

AMPLATZER MUSCULAR VSD OCCLUDER1 
Acute procedure success rate*76.3%
6-month closure rate*93.6&
12-month closure rate*93.3%
24-month closure rate*100.0%
Major adverse events at 24 hours41.0%


*Patients who had a shunt ≤ 2 mm at follow-up interval as assessed by investigator.

Amplatzer™ Post-Infarct VSD Occluder Clinical Data

The safety and effectiveness of the Amplatzer™ P.I. Muscular VSD Occluder were evaluated in 44 post-myocardial infarction VSD patients.2

AMPLATZER P.I. MUSCULAR VSD OCCLUDER2 
Technical success*95.5%
Acute procedure success rate59.1%
1-month success rate66.7%
Major adverse events34.1%


*Patients in which device placement was attempted and a device was successfully deployed in a defect during a catheterization at some point during the study.
Successful closure of the defect was defined as ≤ 2-mm residual shunt, but may include shunts up to 2.9 mm. Rate is per patients seen.
Successful closure of the defect was defined as ≤ 2-mm residual shunt. Rate is per patients seen.


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References
  1. Amplatzer™ Muscular VSD Occluder Instructions for Use.
  2. Amplatzer™ Post-infarct Muscular VSD Occluder Instructions for Use.

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