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 Fields of 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 or replacement 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 transvascular approach 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 s tent or other frame ; and for clarity, for purposes of this subparagraph ( c ) does not include ( i ) any form of percutaneous access ( using a cut down or not ) to or through a carotid artery using SIS, including but not limited to any vascular pa tching via percutaneous delivery ( e.g. as in the repair of punctures 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 ar tery over or through a device using SIS ( e.g. transcatheter access ) ; ( d ) the use of SIS to patch repair the wall of peripheral veins and arteries, other than carotid arteries, using a sheet form patch product in open surgery and where a surface of the implanted patch forms part of the blood contacting lumen of the vein or artery, but not including the use of SIS in conjunction is with a stent or other frame ; and for clarity, ( i ) for purposes of this subparagraph ( d ) does not 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 to any vascular patching via percutaneous delivery ( e.g. as in the repair of punctures created by percutaneous access devices ), ( b ) any form of indirect 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 a device using SIS ( e.g. transcatheter access ), and ( ii ) patch repair shall be limited to p atch repair as specified above only and does not include the 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 ; and ( e ) SIS pouch devices into which implantable cardiac pacemak er or defibrillator devices are to be inserted at the point of care for subcutaneous implantation in human patients