definiens: means : ( a ) the use of SIS for the repair of myocardial tissue, and for the repair of the pericardial sac . By way of clariﬁcation, the Aziyo Fieldsof Use do include placing the SIS patch material directly into or onto myocardial tissue but do not include the use of SIS for the repair orreplacement of the coronary arteries, or for epicardial infarct repair ; ( b ) the use of SIS for all Atrial Septal Defect ( ASD ) and Ventricular Septal Defect ( VSD ) repair, except for the transvascularapproach to ASD and VSD repair ; ( c ) the use of SIS to repair carotid arteries in an open surgery but not the use of SIS in conjunction with a stent or other frame ; andfor clarity, for purposes of this subparagraph ( c ) does not include ( i ) any form of percutaneous access ( using a cut down or not ) toor through a carotid artery using SIS, including but not limited to any vascular patching via percutaneous delivery ( e.g. as in the repair ofpunctures created by percutaneous access devices ), ( ii ) any form of indirect access to the carotid artery through a vascular vessel using SIS, or(iii ) any form of access to or through a carotid artery over or through a device using SIS ( e.g. transcatheter access ) ; 1 ( d ) the use of SIS to patch repair the wall of peripheral veins and arteries, other than carotid arteries, using a sheet form patchproduct in open surgery and where a surface of the implanted patch forms part of the blood contacting lumen of the vein or artery, but notincluding the use of SIS in conjunction is with a stent or other frame ; and for clarity, ( i ) for purposes of this subparagraph ( d ) doesnot include ( a ) any form of percutaneous access ( using a cut - down or not ) to or through a vein or artery using SIS, including but not limited toany vascular patching via percutaneous delivery ( e.g. as in the repair of punctures created by percutaneous access devices ), ( b ) any form ofindirect access to the vein or artery through a vascular vessel using SIS, or ( c ) any form of access to or through a vein or artery over or through adevice using SIS ( e.g. transcatheter access ), and ( ii ) patch repair shall be limited to patch repair as speciﬁed above only and does not includethe creation or use of a vessel or conduit made out of SIS and does not include any use of SIS to replace or repair any valve ; ( e ) SIS pouch devices into which implantable cardiac pacemaker or deﬁbrillator devices are to be inserted at the point of care forsubcutaneous implantation in human patients ; ( f ) SIS pouch devices into which implantable electronic cardiac stimulation devices, other than cardiac pacemaker or deﬁbrillatordevices, are to be inserted at the point of care for subcutaneous implantation in human patients ( hereafter the ) ; and ( g ) SIS pouch devices into which implantable electronic neurostimulation devices for deep brain stimulation, spinal nerve and sacralnerve stimulation to relieve chronic pain, and nerve stimulation to help control bladder, digestive, abdomen, and bowel movements, are to beinserted at the point of care for subcutaneous implantation in human patients ( hereafter the ) . ”