Amplatzer Muscular VSD Occluder

Approval order statement

APPROVAL FOR THE AMPLATZER MUSCULAR VSD OCCLUDER. THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH A COMPLEX VENTRICULAR SEPTAL DEFECT (VSD) OF SIGNIFICANT SIZE TO WARRANT CLOSURE (LARGE VOLUME LEFT TO RIGHT SHUNT, PULMONARY HYPERTENSION AND/OR CLINICAL SYMPTOMS OF CONGESTIVE HEART FAILURE) WHO ARE CONSIDERED TO BE AT HIGH RISK FOR STANDARD TRANSATRIAL OR TRANSARTERIAL SURGICAL CLOSURE BASED ON ANATOMICAL CONDITIONS AND/OR BASED ON OVERALL MEDICAL CONDITION. HIGH RISK ANATOMICAL FACTORS FOR TRANSATRIAL OR TRANSARTERIAL SURGICAL CLOSURE INCLUDE PATIENTS: 1) REQUIRING LEFT VENTRICULOTOMY OR AN EXTENSIVE RIGHT VENTRICULOTOMY; 2) WITH A FAILED PREVIOUS VSD CLOSURE; 3) WITH MULTIPLE APICAL AND/OR ANTERIOR MUSCULAR VSDS (?SWISS CHEESE SEPTUM?); OR 4) WITH POSTERIOR APICAL VSDS COVERED BY TRABECULAE.