Humanitarian Device. Authorized by Federal law for use in the treatment of acute perforations of
native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter. The
effectiveness of this device for this use has not been demonstrated. Institutional Review Board (IRB)
full board review and approval is required prior to use. BIOTRONIK is required to verify adequate IRB
approval documentation prior to product shipment. IRB continuing renewal maintenance is required.