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The HeRO® Graft is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted peripheral venous access sites suitable for fistulas or grafts. The HeRO® Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the KDOQI guidelines' as patients who: - . Have become catheter-dependent or who are approaching catheter-dependency (i.e.. have exhausted all other access options, such as arteriovenous fistulas and grafts). - Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as . determined by a history of previous access failures or venography. - Are failing fistulas or grafts due to poor venous outflow as determined by access failure . or venography (e.g. fistula/graft salvage). - Have poor remaining venous access sites for creation of a fistula or graft as determined . by ultrasound or venography. - Have a compromised central venous system or central venous stenosis (CVS) as . determined by history or previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography. - . Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.2

The HeRO Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis composed of three components: Arterial Graft Component, Venous Outflow Component and Accessory Component Kit. The Venous Outflow Component is made of radiopaque silicone and contains reinforcing braided filaments that impart kink and crush resistance. During surgery, the Venous Outflow Component is sized to fit the patient by cutting it to the proper length and sliding it over the barbs of the connector on the Arterial Graft Component. The Arterial Graft Component is a conventional ePTFE hemodialysis graft that has been attached to a titanium connector. The Accessory Component Kit (a convenience kit) contains instruments that assist in the implantation of the HeRO Graft.

The HeRO® Graft is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted peripheral venous access sites suitable for fistulas or grafts. The HeRO® Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the KDOQ! guidelines' as patients who: - ♥ Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts). - Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as . determined by a history of previous access failures or venography. - t Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography(e.g. fistula/graft salvage). - . Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography. - Have a compromised central venous system or central venous stenosis (CVS) as . • determined by history or previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography. - Are receiving inadequate dialysis clearance (i.e., low KIV) via cathefers. KDOQI guidelines recommend a minimum Kt/V of 1.4.2

The HeRO® Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis composed of three components: HeRO® Arterial Graft Component, HeRO® Venous Outflow Component and HeRO® Accessory Component Kit. The HeRO® Venous Outflow Component is made of radiopaque silicone and contains reinforcing braided filaments that impart kink and crush resistance. During surgery, the outflow component is sized to fit the patient by cutting it to the proper length and sliding it over the barbs of the connector on the graft component. The HeRO® Arterial Graft Component is a conventional ePTFE hemodialysis graft that has been attached to a titanium connector. The HeRO® Accessory Component Kit (a convenience kit) contains tools that assist in the implantation of the HeRO® Graft.

The HeRO™ Vascular Access Device is intended for use in maintaining long-term hemodialysis access in patients who have exhausted peripheral vascular access sites suitable for fistulas or grafts. The HeRO™ Vascular Access Device is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheterdependent patients are readily identified using the K/DOQI guidelines1 as patients who: - Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts). - Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography. - Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography. - Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography. - Have a compromised central venous system or central venous stenosis (CVS) as determined by history or previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography. - Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. K/DOQI guidelines recommend a minimum Kt/V of 1.4.

The HeRO™ Vascular Access Device is a non-autogenous (i.e., synthetic) vascular access device composed of three components: HeRO™ Arterial Graft Component, HeRO™ Venous Outflow Component and HeRO™ Accessory Kit (a convenience kit). The HeRO™ Venous Outflow Component is made of radiopaque silicone reinforced with braided filaments that impart kink and crush resistance. During surgery, the barbs of the connector on the Outflow Component is sized to fit the patient by cutting it to the proper length and sliding it over the band in the patient. The HeRO™ Arterial Graft Component is a conventional ePTFE hemodialysis graft that has been attached to a titanium connector. The HeRO™ Vascular Access Component Kit (a convenience kit) contains tools that assist in the implantation of the HeRO™ Vascular Access Device.