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.
NEW VERSION AVAILABLE
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.