STRUCTURAL INTERVENTIONS

AMPLATZER™ VENTRICULAR SEPTAL DEFECT OCCLUDERS CLINICAL DATA

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.


GET THE AMPLATZER PORTFOLIO APP

The Amplatzer Portfolio App helps physicians determine which Amplatzer Structural Interventions device to use by suggesting applicable devices based on respective Instructions for Use.
 

MAT-2201731 v2.0 | Item approved for OUS use only.

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