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™ 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|
|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-2115461 v1.0 | Item approved for U.S. use only.