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Although a number of embolization protection devices are currently under investigation, only the PercuSurge GuardWire Plus^TM 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PCI has been completed, an aspiration catheter removes the debris and pooled blood, and the balloon is deflated and withdrawn, allowing blood flow to resume.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.

None

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.

12/22/2003: Code Reference section completed

10/13/2006: Policy reviewed, no changes

Hayes Medical Technology Directory

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