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.

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MAT-2201731 v1.0 | Item approved for Global OUS use only.

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MAT-2000631 v10.0 | Item approved for OUS use only.

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