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DESCRIPTIONDistal embolization protection devices are designed to provide temporary vascular occlusion during diagnostic and interventional procedures in the coronary vasculature, specifically during treatment of stenosed or occluded saphenous vein grafts (SVGs). The objective of the device is to reduce or eliminate the risk of serious periprocedural complications, including abrupt vessel closure, myocardial infarction (MI), stroke, and death due to distal embolization, by capturing and removing embolic debris before it can travel to the myocardium or cerebellum and block blood flow.
Although a number of embolization protection devices are currently under investigation, only the PercuSurge GuardWire PlusTM Temporary Occlusion and Aspiration System (PercuSurge, Inc., Sunnyvale, CA, a division of Medtronic, Inc., Minneapolis, MN) has been approved for marketing by the FDA. The PercuSurge is an intravascular balloon and aspiration device intended for use in coronary artery bypass graft (CABG) patients undergoing percutaneous coronary interventions (PCIs) for stenosed or occluded saphenous vein grafts (SVGs). Before PCI, the PercuSurge device is advanced beyond the lesion and the balloon is inflated to occlude blood flow briefly and prevent distal embolization by atherosclerotic and thrombotic debris that may be dislodged during angioplasty and stenting. After PCI has been completed, an aspiration catheter removes the debris and pooled blood, and the balloon is deflated and withdrawn, allowing blood flow to resume.
The use of the PercuSurge GuardWire system for distal embolization protection in patients undergoing angioplasty and/or stenting of existing SVGs is considered investigational.
The use of the PercuSurge GuardWire system as a primary treatment of blocked coronary arteries or for distal embolization protection during PTCA of native coronary vessels is considered investigational.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY8/2002: Approved by Medical Policy Advisory Committee (MPAC)
12/22/2003: Code Reference section completed
10/13/2006: Policy reviewed, no changes
Hayes Medical Technology Directory
CODE REFERENCEAll codes billed are considered investigational and not eligible for coverage.