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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PCI has been completed, an aspiration catheter removes the debris and pooled blood, and the balloon is deflated and withdrawn, allowing blood flow to resume.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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY8/2002: Approved by Medical Policy Advisory Committee (MPAC)
12/22/2003: Code Reference section completed
10/13/2006: Policy reviewed, no changes
08/18/2015: Code Reference section updated for ICD-10. Removed ICD-9 diagnosis codes 414.02 and 996.72.
06/01/2016: Policy number added. Investigative definition updated in Policy Guidelines section.
Hayes Medical Technology Directory
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.