Singapore - English - HSA (Health Sciences Authority)

novomed incorporation pte. ltd. - general & plastic surgery - the gore viabahn® endoprosthesis is a flexible, self expanding endoluminal prosthesis intended for endovascular grafting of peripheral arteries.

Australia - English - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 31744 - cardiovascular patch, synthetic - the device is a high strength, low thrombotic, synthetic patch designed to decrease suture line bleeding in cardiovascular repair and reconstruction procedures. advanced elastomeric fluoropolymer helps seal around penetrating sutures. for use in cardiovascular patching.

Australia - English - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 61423 - multipurpose surgical mesh, synthetic polymer, non-bioabsorbable, antimicrobial - an implantable surgical mesh comprising of expanded eptfe with two functionally distinct surfaces, a smooth side and a textured side. the smooth surface is impregnated with the plus antimicrobial coating and functions to minimize visceral tissue attachment. the textured side is a corduroy-like surface which allows for tissue ingrowth from the abdominal wall, particularly the peritoneum. some configurations also possess macropores or holes to facilitate a more rapid tissue fixation. intended for use in the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.

Australia - English - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 62573 - aortic arch endovascular stent-graft - the aortic component (ac) is a component of the gore? tag? thoracic branch endoprosthesis (tbe). the endoprosthesis functions as a new blood conduit, with inlet and outlet to the endoprosthesis for blood flow. the self-expanding stent frame serves to maintain an open vessel lumen while the eptfe graft material serves as a blood flow conduit. the gore? tag? thoracic branch endoprosthesis (tbe) is intended for endovascular repair of pathologies of the descending thoracic aorta requiring a proximal landing zone including the left subclavian artery while maintaining blood flow into the left subclavian artery.

Australia - English - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 63144 - aortic arch endovascular stent-graft extender - the aortic extender component (ae) is an optional component of the gore? tag? thoracic branch endoprosthesis (tbe). this component is used to improve sealing and/or add seal length to the proximal end of the aortic component within the aorta. the self-expanding stent frame serves to maintain an open vessel lumen while the eptfe graft material serves as a blood flow conduit. the gore? tag? thoracic branch endoprosthesis (tbe) is intended for endovascular repair of pathologies of the descending thoracic aorta requiring a proximal landing zone including the left subclavian artery while maintaining blood flow into the left subclavian artery.

Australia - English - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 62571 - aortic arch branch vessel endovascular stent-graft - the side branch component (sb) is a component of the gore? tag? thoracic branch endoprosthesis (tbe). it bridges the aortic component (ac) and the left subclavian artery, allowing for exclusion of the native vasculature while maintaining perfusion of a branch vessel located within the proximal aortic landing zone. the self-expanding stent frame serves to maintain an open vessel lumen while the eptfe graft material serves as a blood flow conduit. it also includes the cbas? heparin surface. the gore? tag? thoracic branch endoprosthesis (tbe) is intended for endovascular repair of pathologies of the descending thoracic aorta requiring a proximal landing zone including the left subclavian artery while maintaining blood flow into the left subclavian artery.

Australia - English - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 58865 - vascular introducer kit - the device consists of the introducer sheath tube for passage of endovascular tools, a hemostasis valve attached to the sheath tube to minimize bleeding through the sheath during the procedure, and a dilator with a tapered leading end which inserts through the sheath and valve assembly to provide a smooth transition of the wire to the dilator and the dilator to the sheath while advancing the introducer sheath assembly into the patient?s vasculature system. the gore? dryseal flex introducer sheath is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

Singapore - English - HSA (Health Sciences Authority)

novomed incorporation pte. ltd. - cardiovascular - gore® propaten® vascular graft is indicated for patients who require replacement or bypass of peripheral vessels due to occlusive or aneurysmal diseases or trauma, or for patients who require arteriovenous hemodialysis access in the upper or lower extremities due to end-stage renal disease (esrd). gore® propaten® vascular graft configured for pediatric shunt is indicated for staged palliative repair of cyanotic congenital heart disease (cchd).

Australia - English - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 66383 - intravascular occluding/stent-graft post-dilation balloon catheter - a compliant polyurethane balloon is mounted on the leading end of a 3 lumen catheter shaft. termination of the leading end is an atraumatic catheter leading tip for smooth transition from the guidewire to catheter. radiopaque markers indicate the proximal and distal end of the balloon which aid in placement under fluoroscopy. both of the lumens facilitate balloon catheter preparation, inflation and deflation. at the trailing end is a dual port y-arm which allows for over-the-wire access. the gore? molding and occlusion balloon catheter (mob) is intended to serve as a balloon catheter accessory device. ballooning of a stent graft may improve molding of the graft material and fixation of the stent graft to the vessel wall. balloon occlusion of a large diameter vessel may provide hemostasis until vessel repair may be achieved.

Singapore - English - HSA (Health Sciences Authority)

novomed incorporation pte. ltd. - general & plastic surgery - it is intended for use in all types of soft tissue approximation, including use in cardiovascular surgery , but not in ophthalmic surgery, microsurgery, and peripheral neural tissue.