GRAFTMASTER RX Coronary Stent Graft System | 合法醫療器材資訊網

Long-termoutcomeforthispermanentimplantisunknownatpresent.IRBApprovalRequiredforUse.PhotostakenbyandonfileatAbbott.

Humanitarian Device

Humanitarian 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.

Indications

The 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.

Contraindications

GRAFTMASTER™ RX is contraindicated for use in:

Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated. ...

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