A U.S. Food and Drug Administration (FDA) approved percutaneous septal occlusion device used according to labeling, may be considered medically necessary for ANY ONE of following cardiac septal defects:
- Closure of a secundum atrial septal defect (ASD); or
- Closure of a fenestrated septal opening as a result of the Fontan procedure; or
- Closure of a patent ductus arteriosus (PDA); or
- Closure of a complex ventricular septal defect (VSD); or
- For individuals that are considered high risk for standard transarterial or transarterial surgical VSD closure due to anatomic conditions and overall medical condition; or
- Closure of surgical shunts or collaterals.
A percutaneous septal occlusion device is contraindicated for use in individuals with ANY of the following:
- Known to have local or generalized sepsis, or any systemic infection that cannot be successfully treated within one (1) month prior to device placement; or
- Whose size or condition would cause the individual to be a poor candidate for cardiac catheterization; or
- With the margins of the defect less than five (5) mm to the coronary sinus, AV valves and right upper lobe pulmonary vein; or
- With thrombus at or near the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained unless the individual is protected with other embolic protection devices such as a vena cava filter; or
- Whose anatomy would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins should a septal occluder be used; or
- With an intra-cardiac mass or vegetation; or
- Unable to take anti-platelet or anticoagulant medications such as aspirin, heparin, or warfarin, successfully prior to device placement; or
- Whose vasculature is inadequate to accommodate a septal occlusion device.
All other devices or uses are considered experimental and investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.