GRAFTMASTER RX Coronary Stent Graft System | 合法醫療器材資訊網
TheGRAFTMASTERRXCoronaryStentGraftSystemisdesignedtotreatfreeperforationsinnativecoronaryvesselsorsaphenousveinbypassgrafts.
Humanitarian DeviceHumanitarian Device. Authorized by Federal Law for the 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.
IndicationsThe GRAFTMASTER™ RX 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. Long-term outcome for this permanent implant is unknown at present.
ContraindicationsGRAFTMASTER™ RX is contraindicated for use in:
Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated. ...GRAFTMASTER RX Coronary Stent Graft System | 合法醫療器材資訊網
Graftmaster Rx Coronary Stent Graft System | 合法醫療器材資訊網
藥物資訊 | 合法醫療器材資訊網
Humanitarian Use Device | 合法醫療器材資訊網
Vascular Intervention Coronary Covered Coronary Stent ... | 合法醫療器材資訊網
Humanitarian Device Exemption (HDE) | 合法醫療器材資訊網
JOSTEN Coronary Stent Graft INSTRUCTIONS FOR USE ... | 合法醫療器材資訊網
MAUDE Adverse Event Report | 合法醫療器材資訊網
Coronary Perforation and Covered Stents | 合法醫療器材資訊網
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