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 HOURS | 41.0% |
*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 RATE† | 59.1% |
| 1-MONTH SUCCESS RATE‡ | 66.7% |
| MAJOR ADVERSE EVENTS | 34.1% |
*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 v2.0 | Item approved for OUS use only.