The GRAFTMASTER™ RX Coronary Stent Graft System is indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts ≥ 2.75 mm in diameter. The effectiveness of this device for this use has not been demonstrated. The long-term outcome of this permanent implant is unknown at present.
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